Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-02-01 @ 7:56 PM
Study NCT ID:
NCT03699735
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single (Participant)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assignment Each participant will be treated with each test condition in a randomized order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual binaural Hearing abilities', 'timeFrame': '2 weeks', 'description': 'Primary Outcome measurement is to measure the speech understanding in noise \\[SNR in dB\\] for the beam former principles A, B and C'}], 'secondaryOutcomes': [{'measure': 'Speechunderstanding for different beam form principles', 'timeFrame': '2 weeks', 'description': 'Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference \\[SNR in dB\\] and Binaural Masking Level Difference \\[SNR in dB\\] and speech test \\[Oldenburger Satztest in noise \\[SNR in dB\\]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids\n* Sensorineural hearing loss (N4-N6 according to ISO 60118-15)\n* Good written and spoken (Swiss) German language skills\n* Healthy outer ear\n* Informed Consent as documented by signature\n* Symmetric hearing loss below 1000 Hz\n\nExclusion Criteria:\n\n* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product\n* Limited mobility and not in the position to attend weekly appointments on study site\n* Inability to produce a reliable hearing test result\n* Known psychological problems\n* Central hearing disorders'}, 'identificationModule': {'nctId': 'NCT03699735', 'briefTitle': 'Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application', 'orgStudyIdInfo': {'id': 'Sonova2018_31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hearing Aid with beam form principle_A', 'description': 'Device: Hearing Aid beam former principle\\_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.', 'interventionNames': ['Device: Bolero B90-SP']}, {'type': 'EXPERIMENTAL', 'label': 'Hearing Aid with beam form principle_B', 'description': 'Device: Hearing Aid beam former principle\\_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.', 'interventionNames': ['Device: Bolero B90-SP']}, {'type': 'EXPERIMENTAL', 'label': 'Hearing Aid with beam form principle_C', 'description': 'Device: Hearing Aid beam former principle\\_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.', 'interventionNames': ['Device: Bolero B90-SP']}], 'interventions': [{'name': 'Bolero B90-SP', 'type': 'DEVICE', 'description': 'Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss', 'armGroupLabels': ['Hearing Aid with beam form principle_A', 'Hearing Aid with beam form principle_B', 'Hearing Aid with beam form principle_C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8712', 'city': 'Stäfa', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Sonova AG', 'geoPoint': {'lat': 47.24254, 'lon': 8.72342}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}