Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05468918
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Real World Perspectives on Advancements in Hearing Aid Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phonakaudiologyresearch@gmail.com', 'phone': '630-821-5000', 'title': 'Director of Research', 'organization': 'Sonova USCS'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 Weeks. Participants had one day testing in the lab followed by a two week home trial.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants Who Wore Comparator Devices', 'description': 'All participants who completed lab testing and home trial with the Comparator devices.\n\nPhonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'All Participants Who Wore Audeo Lumity Devices', 'description': 'All participants who completed lab testing and home trial with the Audeo Lumity devices.\n\nPhonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech in Noise Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Tested With Both Devices.', 'description': 'Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.'}], 'classes': [{'title': 'Percent correct with Lumity devices', 'categories': [{'measurements': [{'value': '84.84', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '99'}]}]}, {'title': 'Percent correct with comparator devices', 'categories': [{'measurements': [{'value': '77.16', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '98.5'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of study', 'description': 'A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.', 'unitOfMeasure': 'percentage of correct responses', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Perception of Listening Effort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Tested With Both Devices.', 'description': 'Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.'}], 'classes': [{'title': 'Listening effort rating with Lumity devices', 'categories': [{'measurements': [{'value': '5.82', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Listening effort rating with comparator devices', 'categories': [{'measurements': [{'value': '6.82', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of study', 'description': 'Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Tested With Comparator Devices First, Than Audeo Lumity Devices', 'description': 'All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices.\n\nPhonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces'}, {'id': 'FG001', 'title': 'Participants Tested With Audeo Lumity First, Than Comparator Devices', 'description': 'All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices.\n\nPhonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants Tested With Both Devices.', 'description': 'Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-24', 'size': 209792, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-12T12:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were blinded as to which device they were wearing during the lab testing.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2022-07-18', 'resultsFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech in Noise Test', 'timeFrame': 'Day 1 of study', 'description': 'A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.'}, {'measure': 'Subjective Perception of Listening Effort', 'timeFrame': 'Day 1 of study', 'description': 'Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.', 'detailedDescription': 'Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.\n\nThis study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate sensorineural hearing loss\n* Experienced hearing aid user\n* Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial\n* Smartphone user for receiving study alerts\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Not willing to wear hearing aid'}, 'identificationModule': {'nctId': 'NCT05468918', 'briefTitle': 'Real World Perspectives on Advancements in Hearing Aid Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Real World Perspectives on Advancements in Hearing Aid Technology', 'orgStudyIdInfo': {'id': 'SRF-2855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants tested with comparator devices first, then Audeo Lumity devices', 'description': 'All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices.', 'interventionNames': ['Device: Phonak Audeo previous generation hearing aids', 'Device: Phonak Audeo Lumity hearing aids']}, {'type': 'EXPERIMENTAL', 'label': 'Participants who were tested with Audeo Lumity first, then comparator devices', 'description': 'All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices.', 'interventionNames': ['Device: Phonak Audeo previous generation hearing aids', 'Device: Phonak Audeo Lumity hearing aids']}], 'interventions': [{'name': 'Phonak Audeo previous generation hearing aids', 'type': 'DEVICE', 'description': 'Receiver-in-canal (RIC) hearing aids with universal earpieces', 'armGroupLabels': ['Participants tested with comparator devices first, then Audeo Lumity devices', 'Participants who were tested with Audeo Lumity first, then comparator devices']}, {'name': 'Phonak Audeo Lumity hearing aids', 'type': 'DEVICE', 'description': 'Receiver-in-canal (RIC) hearing aids with universal earpieces', 'armGroupLabels': ['Participants tested with comparator devices first, then Audeo Lumity devices', 'Participants who were tested with Audeo Lumity first, then comparator devices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Phonak Audiology Research Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}