Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT04995666
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hearing Aid Quality and Reliability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-24', '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': 'Phonak Audiology Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Complication', 'notes': 'Participant reported pain and moisture in left ear 3 weeks after hearing aid fitting. Issue resolved after seeing physician and receiving medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'hearing aid devices', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid'}], 'classes': [{'title': 'Number of units that PASS manufacturer specifications', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Number of units that FAIL manufacturer specifications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 1 of study', 'description': 'Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.\n\nElectroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.', 'unitOfMeasure': 'hearing aid devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hearing aid devices', 'denomUnitsSelected': 'hearing aid devices', 'populationDescription': 'All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment'}, {'type': 'PRIMARY', 'title': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'hearing aid devices', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid'}], 'classes': [{'title': 'Number of devices that PASS manufacturer specifications specifications', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Number of devices that FAIL manufacturer specifications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 45 of study', 'description': 'Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).', 'unitOfMeasure': 'hearing aid devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hearing aid devices', 'denomUnitsSelected': 'hearing aid devices', 'populationDescription': 'All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment'}, {'type': 'PRIMARY', 'title': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'hearing aid devices', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid'}], 'classes': [{'title': 'Number of devices that PASS manufacturer specifications', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Number of devices that FAIL manufacturer specifications', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 90 of study', 'description': 'Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).', 'unitOfMeasure': 'hearing aid devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hearing aid devices', 'denomUnitsSelected': 'hearing aid devices', 'populationDescription': 'All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment. One participant lost a device, therefore total number of devices analyzed on Day 90 is 37.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids\n\nPhonak Audeo hearing aid: Rechargeable hearing aid'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-01', 'size': 194694, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T13:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2021-06-11', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-24', 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1', 'timeFrame': 'Day 1 of study', 'description': 'Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.\n\nElectroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.'}, {'measure': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45', 'timeFrame': 'Day 45 of study', 'description': 'Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).'}, {'measure': 'Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90', 'timeFrame': 'Day 90 of study', 'description': 'Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with mild to moderate severe sensorineural hearing loss\n* Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)\n\nExclusion Criteria:\n\n* Unable or unwilling to wear study devices during a home trial\n* Unable or unwilling to come to lab for study visits'}, 'identificationModule': {'nctId': 'NCT04995666', 'briefTitle': 'Hearing Aid Quality and Reliability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Hearing Aid Quality Check and Reliability Study', 'orgStudyIdInfo': {'id': 'SRF-368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing Aid', 'description': 'Participants will wear Phonak rechargeable Audeo hearing aids', 'interventionNames': ['Device: Phonak Audeo hearing aid']}], 'interventions': [{'name': 'Phonak Audeo hearing aid', 'type': 'DEVICE', 'description': 'Rechargeable hearing aid', 'armGroupLabels': ['Hearing Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sonova', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}