Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-01 @ 9:37 AM
Study NCT ID:
NCT05859568
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-13
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baseline Performance and Fitting Parameters for Sonova Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech performance in noise', 'timeFrame': '1 day', 'description': 'The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Localization performance', 'timeFrame': '1 day', 'description': 'A secondary efficacy endpoint is a front/back localization task where filtered pink noise is presented at 60dBA from one of six speakers in a 360 degree array. Scores are generated in percent correct; the scores obtained from the pinna-located microphone will be compared to the localization scores using the pinna-simulated microphone.'}, {'measure': 'Analysis of usability and preference questionnaire', 'timeFrame': '8 weeks', 'description': 'Subject responses captured on a usability and preference questionnaire at the initial visit will be compared to responses on the questionnaire administered after each two-week chronic use interval. Questions will inquire about subject\'s ability and experience hearing and listening in different situations and wearing configuration preferences. The questions are rated on a 5-point Likert scale with varying strength, such as "It was easy to verify proper microphone function" with answers ranging from strongly disagree to strongly agree.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Ear Diseases', 'Hearing Disorders', 'Otolaryngological Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.', 'detailedDescription': 'This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide Informed Consent/Assent\n* Adults (age +18 years) and children (8-17 years) can be enrolled in this study\n\n * If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities\n* Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit\n* English language proficiency as determined by the investigator\n\nExclusion Criteria:\n\n• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints'}, 'identificationModule': {'nctId': 'NCT05859568', 'briefTitle': 'Baseline Performance and Fitting Parameters for Sonova Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Bionics'}, 'officialTitle': 'Baseline Performance and Fitting Parameters for Sonova Products', 'orgStudyIdInfo': {'id': 'CPR2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microphone Location versus Microphone Algorithm Comparison', 'description': 'Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.', 'interventionNames': ['Device: Pinna-located microphone', 'Device: Pinna-simulated microphone algorithm']}], 'interventions': [{'name': 'Pinna-located microphone', 'type': 'DEVICE', 'description': 'Sound processors using a pinna-located microphone', 'armGroupLabels': ['Microphone Location versus Microphone Algorithm Comparison']}, {'name': 'Pinna-simulated microphone algorithm', 'type': 'DEVICE', 'description': 'Sound processors using a pinna-simulated algorithm', 'armGroupLabels': ['Microphone Location versus Microphone Algorithm Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91355', 'city': 'Valencia', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Bionics', 'geoPoint': {'lat': 34.44361, 'lon': -118.60953}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Bionics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}