Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-04 @ 5:55 PM
Study NCT ID:
NCT06743295
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2024-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Noise Reduction in Phonak Hearing Aids
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-word Testing', 'timeFrame': 'Baseline', 'description': 'Participants will listen to a list of 50 words and repeat each word aloud. Results are reported as a percentage of correctly repeated words out of 50.'}, {'measure': 'Sentence Testing', 'timeFrame': 'Baseline', 'description': 'Participants will listen to a list of 20 sentences and repeat each sentence aloud. Results are reported as a percentage of correctly repeated sentences out of 20.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hearing aid'], 'conditions': ['Hearing Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for hearing impaired patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hearing impairment not using hearing aids\n* Individuals with hearing impairment currently using hearing aids\n* Cochlear implant patients with a single-sided implant (using a hearing aid in the opposite ear)'}, 'identificationModule': {'nctId': 'NCT06743295', 'briefTitle': 'AI Noise Reduction in Phonak Hearing Aids', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of Artificial Intelligence Based Noise Reduction in Phonak Hearing Aid on Patients With Hearing Impairment and Cochlear Implants', 'orgStudyIdInfo': {'id': '24-009408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing Aid only', 'description': 'Patients with hearing impairment who do not have a Cochlear implant', 'interventionNames': ['Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction']}, {'type': 'EXPERIMENTAL', 'label': 'Cochlear Implant with Hearing Aid', 'description': 'Patients with hearing impairment who have a single-sided implant (using a hearing aid on the opposite ear)', 'interventionNames': ['Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction']}], 'interventions': [{'name': 'DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction', 'type': 'DEVICE', 'description': 'Participants with hearing loss will be fitted with the Phonak Audéo Sphere™ Infinio (PAI) hearing aid with artificial intelligence (AI)-based noise reduction, which incorporates deep neural networks (DNN) technology to reduce background noise.\n\nSpeech stimuli, presented at a comfortable level of approximately 60 dB SPL (like normal conversation), will be delivered via a loudspeaker positioned directly in front of the participant.\n\nThey will be tested in 3 listening environments: quiet, moderate noise, high noise.\n\nSpeech perception scores will be measured as a function of each hearing aid program setting: quiet setting, moderate noise, and advanced AI-based reduction for high noise.', 'armGroupLabels': ['Cochlear Implant with Hearing Aid', 'Hearing Aid only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Study Coordinator', 'role': 'CONTACT', 'email': 'tombers.nicole@mayo.edu', 'phone': '507-293-2445'}, {'name': 'Aniket A. Saoji', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Research Study Coordinator', 'role': 'CONTACT', 'email': 'tombers.nicole@mayo.edu', 'phone': '507-293-2445'}], 'overallOfficials': [{'name': 'Aniket Saoji, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Otolaryngology', 'investigatorFullName': 'Aniket Saoji', 'investigatorAffiliation': 'Mayo Clinic'}}}}