Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-04-16 @ 7:51 AM
Study NCT ID:
NCT03086135
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of a New Implant System for Bone Conduction Hearing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}, {'id': 'D006314', 'term': 'Hearing Loss, Conductive'}, {'id': 'D046089', 'term': 'Hearing Loss, Mixed Conductive-Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Emmanuel.Mylanus@radboudumc.nl', 'phone': '+31 24 361 49 34', 'title': 'Professor Emmanuel Mylanus', 'organization': 'Radboud University Medical center, Nijmegen'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 42, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'General disorders and administration site conditions other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nervous system disorders other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Wound infection', 'notes': 'Infection at implant site starting shortly after surgery, lead to explantation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infection and infestations', 'notes': 'One subject was hospitalized three days due to an influenza infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrilation', 'notes': '0ne subject was treated for persistent atrial fibrillation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 51, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.8', 'spread': '9.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'PTA4 at 3 months with the Osia system vs Unaided at visit 1', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 3 months after surgery', 'description': "The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.", 'unitOfMeasure': 'dB (Decibel)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.3', 'spread': '8.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in noise at 3 months with the Osia system vs Unaided at visit 1', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 3 months after surgery', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.', 'unitOfMeasure': 'SNR (Speech in Noise Ratio)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.9', 'spread': '9.4', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.9', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.4', 'spread': '8.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'PTA4 at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'PTA4 at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 6 and 12 months after surgery', 'description': "The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.", 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some subjects did not perform the test at one or more visits.'}, {'type': 'SECONDARY', 'title': 'Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '12.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.3', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.4', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.2', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.8', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.7', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.1', 'spread': '10.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.6', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.8', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': '3 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '13.1', 'groupId': 'OG000'}]}]}, {'title': '3 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.9', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '3 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.5', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '3 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.4', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': '3 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.1', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': '3 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.9', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': '3 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.1', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': '3 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.8', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': '3 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.7', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': '3 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.9', 'spread': '13.8', 'groupId': 'OG000'}]}]}, {'title': '6 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': '6 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.2', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '6 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.4', 'spread': '12.0', 'groupId': 'OG000'}]}]}, {'title': '6 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.9', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': '6 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.0', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '6 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.1', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': '6 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.6', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': '6 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.2', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': '6 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.6', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': '6 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.7', 'spread': '12.3', 'groupId': 'OG000'}]}]}, {'title': '12 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.7', 'spread': '12.8', 'groupId': 'OG000'}]}]}, {'title': '12 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.8', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': '12 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.8', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.8', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.2', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': '12 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.8', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': '12 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.6', 'spread': '12.0', 'groupId': 'OG000'}]}]}, {'title': '12 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.0', 'spread': '12.2', 'groupId': 'OG000'}]}]}, {'title': '12 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.9', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-38.8', 'spread': '12.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': "The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency.", 'unitOfMeasure': 'dB (Decibel)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '750, 1500 and 8000 Hz were not included in the eCRF for free-field threshold audiometry test due to an error when the first six subjects entered the study. Measurements at these frequencies were therefore not performed at the first visits. In addition; not all subjects performed the test at all frequencies at all visits.'}, {'type': 'SECONDARY', 'title': 'Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks; 50 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '27.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks; 65 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.8', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks; 80 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '30.8', 'groupId': 'OG000'}]}]}, {'title': '3 months: 50 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '26.8', 'groupId': 'OG000'}]}]}, {'title': '3 months: 65 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '26.8', 'groupId': 'OG000'}]}]}, {'title': '3 months: 80 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.8', 'spread': '31.9', 'groupId': 'OG000'}]}]}, {'title': '6 months: 50 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.5', 'spread': '29.5', 'groupId': 'OG000'}]}]}, {'title': '6 months: 65 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '27.7', 'groupId': 'OG000'}]}]}, {'title': '6 months: 80 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '33.3', 'groupId': 'OG000'}]}]}, {'title': '12 months: 50 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': '24.9', 'groupId': 'OG000'}]}]}, {'title': '12 months: 65 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '23.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: 80 dB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '32.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL \\[% correctly perceived words at 50, 65 and 80 dB SPL\\] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.', 'unitOfMeasure': 'Percentage of correctly perceived words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform the test at one or more visits.'}, {'type': 'SECONDARY', 'title': 'Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '8.1', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.7', 'spread': '8.1', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.6', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 6 and 12 months after surgery', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.', 'unitOfMeasure': 'SNR (Speech in Noise Ratio)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some subjects did not perform the test at one or more visits.'}, {'type': 'SECONDARY', 'title': 'Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '3 months: Ease of communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.1', 'spread': '21.7', 'groupId': 'OG000'}]}]}, {'title': '3 months: Background noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '20.0', 'groupId': 'OG000'}]}]}, {'title': '3 months: Reverberation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.8', 'spread': '23.1', 'groupId': 'OG000'}]}]}, {'title': '3 months: Aversiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': '3 months: Global', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '18.5', 'groupId': 'OG000'}]}]}, {'title': '12 months: Ease of communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.0', 'spread': '19.1', 'groupId': 'OG000'}]}]}, {'title': '12 months: Background noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '20.9', 'groupId': 'OG000'}]}]}, {'title': '12 months: Reverberation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.4', 'spread': '25.8', 'groupId': 'OG000'}]}]}, {'title': '12 months: Aversiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.58', 'spread': '24.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: Global', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.51', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.32', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 3 and 12 months after surgery', 'description': 'The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer some of the questions at one or more visits.'}, {'type': 'SECONDARY', 'title': 'Health Utility Index (HUI) at 3 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '3 months: comprehensive health state', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.081', 'spread': '0.227', 'groupId': 'OG000'}]}]}, {'title': '3 months: Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.035', 'groupId': 'OG000'}]}]}, {'title': '3 months: Hearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.173', 'spread': '0.324', 'groupId': 'OG000'}]}]}, {'title': '3 months: Speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.129', 'groupId': 'OG000'}]}]}, {'title': '3 months: Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.063', 'groupId': 'OG000'}]}]}, {'title': '3 months: Dexterity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': '3 months: Emotion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.120', 'groupId': 'OG000'}]}]}, {'title': '3 months: Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.088', 'groupId': 'OG000'}]}]}, {'title': '3 months: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.258', 'groupId': 'OG000'}]}]}, {'title': '12 months: comprehensive health state', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.243', 'groupId': 'OG000'}]}]}, {'title': '12 months: Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.055', 'groupId': 'OG000'}]}]}, {'title': '12 months: Hearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.149', 'spread': '0.300', 'groupId': 'OG000'}]}]}, {'title': '12 months: Speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.062', 'spread': '0.136', 'groupId': 'OG000'}]}]}, {'title': '12 months: Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.094', 'groupId': 'OG000'}]}]}, {'title': '12 months: Dexterity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.122', 'groupId': 'OG000'}]}]}, {'title': '12 months: Emotion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.144', 'groupId': 'OG000'}]}]}, {'title': '12 months: Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.125', 'groupId': 'OG000'}]}]}, {'title': '12 months: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.334', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.082', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.43', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.72', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.23', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0026', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0024', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.85', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.56', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery and 3 and 12 months after surgery', 'description': 'The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer all questions in the questionnaire at one or both time-points.'}, {'type': 'SECONDARY', 'title': 'Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '3 months: Total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': '3 months: Speech score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': '3 months: Spatial score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': '3 months: Quality score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': '12 months: Total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.69', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': '12 months: Speech score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.94', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': '12 months: Spatial score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '2.52', 'groupId': 'OG000'}]}]}, {'title': '12 months: Quality score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery and 3 and 12 months after surgery', 'description': 'The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer all questions at one or both visits.'}, {'type': 'SECONDARY', 'title': 'Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.16', 'spread': '5.68', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.82', 'spread': '5.94', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.72', 'spread': '5.84', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.85', 'spread': '6.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform a PTA4 measurement at one or more visits.'}, {'type': 'SECONDARY', 'title': 'Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks: 250 hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '10.98', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.22', 'spread': '9.15', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.30', 'spread': '8.49', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '6.65', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '8.39', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.62', 'spread': '7.66', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.18', 'spread': '7.86', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.20', 'spread': '9.58', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'spread': '17.3', 'groupId': 'OG000'}]}]}, {'title': '3 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '9.19', 'groupId': 'OG000'}]}]}, {'title': '3 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.69', 'spread': '8.86', 'groupId': 'OG000'}]}]}, {'title': '3 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.86', 'spread': '8.66', 'groupId': 'OG000'}]}]}, {'title': '3 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '7.22', 'groupId': 'OG000'}]}]}, {'title': '3 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'spread': '7.82', 'groupId': 'OG000'}]}]}, {'title': '3 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.37', 'spread': '8.15', 'groupId': 'OG000'}]}]}, {'title': '3 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.57', 'spread': '9.11', 'groupId': 'OG000'}]}]}, {'title': '3 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.73', 'spread': '10.07', 'groupId': 'OG000'}]}]}, {'title': '3 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': '3 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.1', 'spread': '18.4', 'groupId': 'OG000'}]}]}, {'title': '6 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '8.70', 'groupId': 'OG000'}]}]}, {'title': '6 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.69', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': '6 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'spread': '7.90', 'groupId': 'OG000'}]}]}, {'title': '6 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': '6 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '7.23', 'groupId': 'OG000'}]}]}, {'title': '6 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.61', 'spread': '8.29', 'groupId': 'OG000'}]}]}, {'title': '6 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.76', 'spread': '8.06', 'groupId': 'OG000'}]}]}, {'title': '6 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': '6 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.4', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': '6 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.7', 'spread': '17.6', 'groupId': 'OG000'}]}]}, {'title': '12 months: 250 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '9.81', 'groupId': 'OG000'}]}]}, {'title': '12 months: 500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.91', 'spread': '8.79', 'groupId': 'OG000'}]}]}, {'title': '12 months: 750 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.75', 'spread': '8.65', 'groupId': 'OG000'}]}]}, {'title': '12 months: 1000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.07', 'spread': '7.98', 'groupId': 'OG000'}]}]}, {'title': '12 months: 1500 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.73', 'spread': '8.21', 'groupId': 'OG000'}]}]}, {'title': '12 months: 2000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.80', 'spread': '8.33', 'groupId': 'OG000'}]}]}, {'title': '12 months: 3000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.61', 'spread': '9.13', 'groupId': 'OG000'}]}]}, {'title': '12 months: 4000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.6', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': '12 months: 6000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.6', 'spread': '11.4', 'groupId': 'OG000'}]}]}, {'title': '12 months: 8000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.5', 'spread': '17.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.096', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.015', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.73', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.019', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0046', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.019', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.040', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.037', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0048', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0007', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.11', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.80', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform all measurements at all visits.'}, {'type': 'SECONDARY', 'title': 'Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks: 50 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '24.81', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 65 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.65', 'spread': '19.58', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 80 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '7.34', 'groupId': 'OG000'}]}]}, {'title': '3 months: 50 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.17', 'spread': '26.16', 'groupId': 'OG000'}]}]}, {'title': '3 months: 65 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.48', 'spread': '21.39', 'groupId': 'OG000'}]}]}, {'title': '3 months: 80 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '8.35', 'groupId': 'OG000'}]}]}, {'title': '6 months: 50 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': '6 months: 65 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.73', 'spread': '22.56', 'groupId': 'OG000'}]}]}, {'title': '6 months: 80 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.875', 'spread': '10.02', 'groupId': 'OG000'}]}]}, {'title': '12 months: 50 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.7', 'spread': '29.5', 'groupId': 'OG000'}]}]}, {'title': '12 months: 65 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': '12 months: 80 dB SPL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.61', 'spread': '10.45', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0051', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.56', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.041', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet \\[% correctly perceived words at 50, 65 and 80 dB SPL\\]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.', 'unitOfMeasure': 'Percentage of correctly perceived words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform all measurements at all visits.'}, {'type': 'SECONDARY', 'title': 'Adaptive Speech Recognition in Noise, With Reference Device BP110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.12', 'spread': '6.92', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.19', 'spread': '6.80', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.91', 'spread': '6.80', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.54', 'spread': '7.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.', 'statisticalMethod': "Fisher's non-parametric permutation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.', 'unitOfMeasure': 'SNR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform the test at all visits.'}, {'type': 'SECONDARY', 'title': 'Surgical Information: Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'spread': '27.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgery time in minutes between first incision and last suture', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Soft Tissue Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'spread': '1.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: Soft tissue thickness was measured in mm', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Soft Tissue Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Polishing/Removal at Implant Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Type of Anaesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': 'General', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Local', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Location of BI300 Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': 'Alt 1: distance from the ear channel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.3', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': '9.64Alt 2: horizontally from ear channel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Alt 2: vertically from the ear channel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.64', 'spread': '9.20', 'groupId': 'OG000'}]}]}, {'title': 'Alt 2: distance between receiver and coil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '13.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: where is the location of the BI300 implant, measured in two different ways:\n\nAlternative 1 used for the first 6 subjects: Location from the ear channel in mm.\n\nAlternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil.\n\nValue 9.64 mm vertically from ear channel is correct.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Localization of the BI300 implant measured in two different ways; 6 subjects with alternative 1, 45 subjects with alternative 2.'}, {'type': 'SECONDARY', 'title': 'Incision Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': 'C-shaped flap', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Poesterior flap', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For two subjects two alternatives were checked.'}, {'type': 'SECONDARY', 'title': 'Daily Usage Time of Sound Processor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'Sound processor usage time measured as hours per day.', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer the question at all visits.'}, {'type': 'SECONDARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '18.6', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '16.6', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '20.1', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.9', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer the question at all visits.'}, {'type': 'SECONDARY', 'title': 'Magnet Choice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '4 weeks: strength 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: strength 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '6 weeks strength 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '3 months strength 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '6 months strength 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '12 months strength 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4, 6 weeks, 3, 6 and 12 months', 'description': 'Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not perform all visits.'}, {'type': 'SECONDARY', 'title': 'Softpad Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'classes': [{'title': '6 weeks: yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 weeks: no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': '3 months: yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '3 months: no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': '6 months: yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 months: no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': '12 months: yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '12 months: no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'A question was asked if the subjects used softpads; yes or no could be ticked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some of the subjects did not answer the question at all visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bone-conduction Hearing Device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.\n\nOsia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-14', 'size': 1659531, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-11T03:19', 'hasProtocol': True}, {'date': '2018-04-16', 'size': 633842, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-11T03:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2017-03-09', 'resultsFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-27', 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months', 'timeFrame': 'Baseline before surgery, 3 months after surgery', 'description': "The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds."}, {'measure': 'Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.', 'timeFrame': 'Baseline before surgery, 3 months after surgery', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.'}], 'secondaryOutcomes': [{'measure': 'Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months', 'timeFrame': 'Baseline before surgery, 4 weeks, 6 and 12 months after surgery', 'description': "The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds."}, {'measure': 'Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': "The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is \\<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency."}, {'measure': 'Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL \\[% correctly perceived words at 50, 65 and 80 dB SPL\\] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.'}, {'measure': 'Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months', 'timeFrame': 'Baseline before surgery, 4 weeks, 6 and 12 months after surgery', 'description': 'The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.'}, {'measure': 'Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months', 'timeFrame': 'Baseline before surgery, 3 and 12 months after surgery', 'description': 'The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.'}, {'measure': 'Health Utility Index (HUI) at 3 and 12 Months', 'timeFrame': 'Baseline before surgery and 3 and 12 months after surgery', 'description': 'The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.'}, {'measure': 'Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months', 'timeFrame': 'Baseline before surgery and 3 and 12 months after surgery', 'description': 'The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing.'}, {'measure': 'Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.'}, {'measure': 'Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.'}, {'measure': 'Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet \\[% correctly perceived words at 50, 65 and 80 dB SPL\\]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.'}, {'measure': 'Adaptive Speech Recognition in Noise, With Reference Device BP110', 'timeFrame': 'Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.', 'description': 'The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.'}, {'measure': 'Surgical Information: Time of Surgery', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgery time in minutes between first incision and last suture'}, {'measure': 'Soft Tissue Thickness', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: Soft tissue thickness was measured in mm'}, {'measure': 'Soft Tissue Reduction', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".'}, {'measure': 'Bone Polishing/Removal at Implant Site', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.'}, {'measure': 'Type of Anaesthesia', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.'}, {'measure': 'Location of BI300 Implant', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: where is the location of the BI300 implant, measured in two different ways:\n\nAlternative 1 used for the first 6 subjects: Location from the ear channel in mm.\n\nAlternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil.\n\nValue 9.64 mm vertically from ear channel is correct.'}, {'measure': 'Incision Type', 'timeFrame': 'Visit 2, surgery', 'description': 'Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.'}, {'measure': 'Daily Usage Time of Sound Processor', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'Sound processor usage time measured as hours per day.'}, {'measure': 'Comfort', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.'}, {'measure': 'Magnet Choice', 'timeFrame': '4, 6 weeks, 3, 6 and 12 months', 'description': 'Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.'}, {'measure': 'Softpad Use', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'A question was asked if the subjects used softpads; yes or no could be ticked.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Deafness; Sensoneural Single Sided', 'Conductive Hearing Loss', 'Mixed Hearing Loss']}, 'descriptionModule': {'briefSummary': 'To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects (18 years or older)\n* Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.\n\nOR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).\n\n* Signed informed consent\n* Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)\n\nExclusion Criteria:\n\n* Uncontrolled diabetes as judged by the investigator.\n* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.\n* Insufficient bone quality and quantity for implantation of a BI300 Implant.\n* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period\n* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator\n* Unable to follow investigational procedures, e.g. to complete quality of life scales.\n* Participation in another clinical investigation with pharmaceutical and/or device.'}, 'identificationModule': {'nctId': 'NCT03086135', 'briefTitle': 'Clinical Performance of a New Implant System for Bone Conduction Hearing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Clinical Performance of a New Implant System for Bone Conduction Hearing', 'orgStudyIdInfo': {'id': 'CBAS5539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone-conduction hearing device', 'description': 'The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.', 'interventionNames': ['Device: Osia System']}], 'interventions': [{'name': 'Osia System', 'type': 'DEVICE', 'description': 'An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.', 'armGroupLabels': ['Bone-conduction hearing device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': 'VIC 3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Victorian Eye and Ear Hospital', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '05-830', 'city': 'Kajetany', 'state': 'Nadarzyn', 'country': 'Poland', 'facility': 'World Hearing Center Institute of Physiology and Pathology of Hearing', 'geoPoint': {'lat': 52.0927, 'lon': 20.8141}}], 'overallOfficials': [{'name': 'Emmanuel Mylanus, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud Univerity Medical centre'}, {'name': 'Robert Briggs, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Victorian Eye and Ear Hospita'}, {'name': 'Susan Arndt, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Freiburg'}, {'name': 'Piotr Skarżyński, Ass.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Hearing and Speech'}, {'name': 'Henry Alexander Arts, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}