Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-31 @ 7:28 AM
Study NCT ID:
NCT05197803
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carolina.rubiano@sonova.com', 'phone': '519 895 0100', 'title': 'Study Manager', 'phoneExt': '2135', 'organization': 'Sonova AG'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Hearing instruments do not generally cause mortality or serious adverse events. All participants underwent testing under the study conditions during one day appointment session. Therefore, all participants are combined for the Adverse Events reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'All participants performed the HINT test in a sound room setting and SNR50 scores were obtained under the three study conditions.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech Intelligibility Test in Noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided.'}], 'classes': [{'title': 'dB SNR unaided condition', 'categories': [{'measurements': [{'value': '0.83', 'spread': '3.43', 'groupId': 'OG000'}]}]}, {'title': 'dB SNR aided condition (BTE)', 'categories': [{'measurements': [{'value': '-2.49', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'dB SNR aided condition (RIC)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '2.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '3.32', 'groupDescription': 'The study compared the results between the unaided condition vs. aided condition (BTE)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '3.57', 'groupDescription': 'The study compared the results between the unaided condition vs. aided condition (RIC)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 hours appointment', 'description': "Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.", 'unitOfMeasure': 'decibel (dB) Signal-to-Noise Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for two participants had to be removed from the final analysis. In both cases, the speech intelligibiliy test could not be completed in one or more study conditions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the existing participant local database. The first participant was enrolled on January 10, 2022 and the last participant was enrolled on January 28, 2022.', 'preAssignmentDetails': 'All 25 participants enrolled met the inclusion criteria established for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'All participants are fit with the BTE and the RIC hearing aids and then complete speech intelligibility testing aided and unaided.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66.36', 'spread': '11.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Speech Intelligibility in Noise', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio at which te participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.", 'unitOfMeasure': 'decibels (dB) Signal-to-Noise Ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The same group of 25 participants undergo one similar intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-04', 'size': 111055, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-01-10T19:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One similar intervention; 2 groups based on hearing aid model.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2021-12-16', 'resultsFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-21', 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Intelligibility Test in Noise', 'timeFrame': '2 hours appointment', 'description': "Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.', 'detailedDescription': 'Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).\n* Healthy outer ear.\n* Symmetrical hearing loss.\n* Ability to answer questions and repeat sentences.\n* Informed consent as documented by signature.\n* Willingness to wear different style of hearing aids.\n* Willingness to wear a binaural fitting.\n* Willingness to wear closed domes.\n* Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit\n\nExclusion Criteria:\n\n* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).\n* Limited mobility/not able to come to scheduled visits.\n* Inability to produce reliable hearing test result.\n* Visible congenital or traumatic deformity of the outer ear.\n* History of active drainage from the ear in the previous 90 days.\n* Abnormal appearance of the eardrum and ear canal.\n* Acute or chronic dizziness.\n* Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.\n* Known psychological problems.'}, 'identificationModule': {'nctId': 'NCT05197803', 'briefTitle': 'Clinical Study of Released Unitron RIC and BTE Hearing Aid Models', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models', 'orgStudyIdInfo': {'id': '515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'The same group of participants undergo the same testing conditions. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing - Hearing in Noise Test (HINT) - aided and unaided during one-time visit.', 'interventionNames': ['Device: Hearing aid']}], 'interventions': [{'name': 'Hearing aid', 'type': 'DEVICE', 'description': 'Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2E 1Y6', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Unitron Hearing', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}], 'overallOfficials': [{'name': 'Jinyu Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'jinyu.qian@sonova.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sonova Canada Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}