Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 9:37 PM
Study NCT ID:
NCT05246904
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating a Self-fitting Hearing Aid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054062', 'term': 'Deaf-Blind Disorders'}], 'ancestors': [{'id': 'D003638', 'term': 'Deafness'}, {'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': 'D001766', 'term': 'Blindness'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be randomly assigned and will not know which fit is first.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abbreviated profile of hearing aid benefit', 'timeFrame': '2-3 weeks', 'description': 'Survey of subjective benefit'}, {'measure': 'Speech in noise test, AZ Bio sentences', 'timeFrame': 'Immediately after fitting', 'description': 'Sentence recognition test in background noise'}], 'secondaryOutcomes': [{'measure': 'Subjective sound quality rating', 'timeFrame': '2-3 weeks', 'description': 'Participants rate the quality of sound through hearing aids'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hearing aids, self-fitting'], 'conditions': ['Hearing and Vision Loss']}, 'descriptionModule': {'briefSummary': "Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.", 'detailedDescription': 'The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. We will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). Hearing loss will be measured using the results of a standard clinical hearing test.\n\nWe will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of the field trials will be randomized across participants to account for any potential order effects. After each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate hearing loss ability to follow written directions,\n\nExclusion Criteria:\n\n* inability to use software during first visit'}, 'identificationModule': {'nctId': 'NCT05246904', 'briefTitle': 'Validating a Self-fitting Hearing Aid', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Validating a Self-fitting Hearing Aid', 'orgStudyIdInfo': {'id': 'STUDY00015143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'audiologist arm', 'description': 'A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.', 'interventionNames': ['Other: Fitting algorithm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'self-fit arm', 'description': "Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.", 'interventionNames': ['Other: Fitting algorithm']}], 'interventions': [{'name': 'Fitting algorithm', 'type': 'OTHER', 'description': 'The best fitting algorithm will be selected by the audiologist (arm 1) or software.', 'armGroupLabels': ['audiologist arm', 'self-fit arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}