Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-02 @ 8:03 PM
Study NCT ID:
NCT03131557
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Phonak Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability (phone calls)', 'timeFrame': 'One week', 'description': "The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued."}], 'secondaryOutcomes': [{'measure': 'Zero-defect performance in daily life', 'timeFrame': 'Three weeks', 'description': 'The data, serving as secondary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.'}, {'measure': 'Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)', 'timeFrame': 'One week', 'description': "The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Bilateral Sensorineural, Progressive']}, 'descriptionModule': {'briefSummary': 'A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.', 'detailedDescription': 'Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).'}, '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 and without (experience with) hearing aids\n* Good written and spoken (Swiss) German language skills\n* Healthy outer ear\n* Ability to fill in a questionnaire (p/eCRF) conscientiously\n* Informed Consent as documented by signature\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 in Stäfa (Switzerland)\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* Central hearing disorders'}, 'identificationModule': {'nctId': 'NCT03131557', 'briefTitle': 'Quality Control of CE-Certified Phonak Hearing Aids - 2017_13', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Quality Control of CE-Certified Phonak Hearing Aids - 2017_13', 'orgStudyIdInfo': {'id': 'Sonova2017_13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Line extension of the Phonak Audéo B hearing aid', 'description': 'The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.', 'interventionNames': ['Device: Line extension of the Phonak Audéo B product family']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phonak Audéo B hearing aid', 'description': 'Phonak Audéo B will be fitted to the participants individual hearing loss.', 'interventionNames': ['Device: Phonak Audéo B']}], 'interventions': [{'name': 'Line extension of the Phonak Audéo B product family', 'type': 'DEVICE', 'description': 'The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.', 'armGroupLabels': ['Line extension of the Phonak Audéo B hearing aid']}, {'name': 'Phonak Audéo B', 'type': 'DEVICE', 'description': 'Phonak Audéo B will be fitted to the participants individual hearing loss.', 'armGroupLabels': ['Phonak Audéo B hearing aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8712', 'city': 'Stäfa', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Sonova AG', 'geoPoint': {'lat': 47.24254, 'lon': 8.72342}}], 'overallOfficials': [{'name': 'Simone Ebbing, B.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sonova AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}