Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05733169
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2023-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-calculation for Frequency Lowering With Hearing Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frequency Lowering']}, 'descriptionModule': {'briefSummary': 'Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced hearing aid user (minimum use duration 1 year)\n* Adult (minimum age: 18 years),\n* Experience with frequency lowering,\n* Hearing thresholds with N5-N7, S1, S2, S3 hearing loss\n* Symmetrical hearing loss (difference between ears \\<= 10 dB for 1kHz-6kHz) ,\n* Sensorineural hearing loss,\n* Air Conduction - bone conduction gap \\<= 10 dB,\n* Written and spoken German,\n* Ability to understand instruction,\n* Ability to describe listening experiences,\n* Ability to attend to the appointments,\n* Ability to fill in a questionnaire conscientiously\n* Healthy outer ear (without previous surgical procedures)\n* Hearing loss within the fitting ranges of the investigational product,\n* Informed consent as documented by signature.\n\nExclusion Criteria:\n\n* Clinical contraindications deformity of the ear (closed ear canal\n* or absence of pinna),\n* Not willing to wear the hearing aid,\n* Fluctuating hearing that could influence the results,\n* Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,\n* Limited mobility and not in the position to attend all appoint-ments,\n* Limited ability to describe listening impressions/experiences and the use of the hearing aid,\n* Inability to produce a reliable hearing test result,\n* Massively limited dexterity,\n* Known psychological problems,\n* Known central hearing disorders.'}, 'identificationModule': {'nctId': 'NCT05733169', 'briefTitle': 'Pre-calculation for Frequency Lowering With Hearing Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Pre-calculation for Frequency Lowering With Hearing Devices', 'orgStudyIdInfo': {'id': '5937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing impaired group', 'description': 'The hearing impaired group will compare the reference condition with the intervention condition.', 'interventionNames': ['Other: Frequency lowering intervention', 'Other: Frequency lowering reference']}], 'interventions': [{'name': 'Frequency lowering intervention', 'type': 'OTHER', 'otherNames': ['Intervention condition'], 'description': 'Modified parametrization of the current frequency lowering parametrization.', 'armGroupLabels': ['Hearing impaired group']}, {'name': 'Frequency lowering reference', 'type': 'OTHER', 'otherNames': ['Reference condition'], 'description': 'Current frequency lowering parametrization', 'armGroupLabels': ['Hearing impaired group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8712', 'city': 'Stäfa', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Sonova AG', 'geoPoint': {'lat': 47.24254, 'lon': 8.72342}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}