Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 3:24 PM
Study NCT ID:
NCT02545569
Status:
UNKNOWN
Last Update Posted:
2019-08-30
First Post:
2015-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-09-07', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective measurement of speech intelligibility related to the intervention.', 'timeFrame': '5 years', 'description': 'SNR (speech to noise ratio) in decibel.'}, {'measure': 'Objective measurement of the transfer function related to the intervention.', 'timeFrame': '5 years', 'description': 'REM (real ear measurement) in decibel.'}, {'measure': 'Objective measurement from the position of the outer ear related to the test subject.', 'timeFrame': '5 years', 'description': 'Measurement in degree.'}, {'measure': 'Objective measurement from the size of the outer ear related to the test subject.', 'timeFrame': '5 years', 'description': 'Measurement in micron.'}, {'measure': 'Objective measurement of humidity in the ear canal related to the test subject and the intervention.', 'timeFrame': '5 years', 'description': 'Measurement in percent.'}, {'measure': 'Objective measurement of temperature in the ear canal related to the test subject and the intervention.', 'timeFrame': '5 years', 'description': 'Measurement in degree centigrade.'}], 'secondaryOutcomes': [{'measure': 'Subjective rating of the intervention via questionnaire.', 'timeFrame': '5 years', 'description': 'Ordinal scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Bilateral or Unilateral']}, 'descriptionModule': {'briefSummary': 'The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.', 'detailedDescription': 'This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.\n\nThe purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only adult participants between 18 and 99 years\n* lnformed Consent as documented by signature (Appendix lnformed Consent Form)\n* Ability to fill in a questionnaire conscientious\n* Healthy outer ear (w/o previous surgical procedures)\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\n* Limited ability to describe listening impressions/experiences and the use of the hearing aid\n* lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist\n* Massively limited dexterity\n* Psychological problems\n* Central hearing problems'}, 'identificationModule': {'nctId': 'NCT02545569', 'acronym': 'CPS', 'briefTitle': 'Evaluation of New Custom Made Hearing Product Technology and Shell Modification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phonak AG, Switzerland'}, 'officialTitle': 'Evaluation of New Custom Made Hearing Product Technology and Shell Modification', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2014-0459'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hearing Device Type A', 'description': 'In the ear (ITE) hearing aid, 1-3 weeks wearing', 'interventionNames': ['Device: hearing aid (MD class IIa) - ITE, BTE, RIC']}, {'type': 'EXPERIMENTAL', 'label': 'Hearing Device Type B', 'description': 'In the ear (ITE) hearing aid, 1-3 weeks wearing', 'interventionNames': ['Device: hearing aid (MD class IIa) - ITE, BTE, RIC']}], 'interventions': [{'name': 'hearing aid (MD class IIa) - ITE, BTE, RIC', 'type': 'DEVICE', 'otherNames': ['hearing accessory (MD class I) - DM systems, FM systems, remote control'], 'description': 'Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.', 'armGroupLabels': ['Hearing Device Type A', 'Hearing Device Type B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8712', 'city': 'Stäfa', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Jana-Kosima Schwarzlos', 'role': 'CONTACT', 'email': 'JanaKosima.Schwarzlos@sonova.com', 'phone': '0041 58 928 0101'}], 'facility': 'Sonova AG', 'geoPoint': {'lat': 47.24254, 'lon': 8.72342}}], 'centralContacts': [{'name': 'Jana-Kosima Schwarzlos, B.Sc.', 'role': 'CONTACT', 'email': 'JanaKosima.Schwarzlos@sonova.com', 'phone': '+41 58 928 0101'}], 'overallOfficials': [{'name': 'Jana-Kosima Schwarzlos, B.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Switzerland, Sonova AG, CH-8712 Staefa, Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phonak AG, Switzerland', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}