Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07213505
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
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': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oldenburg Sentence Test in noise (S0 N±135)', 'timeFrame': 'immediately after the intervention', 'description': 'Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested)'}], 'secondaryOutcomes': [{'measure': 'Oldenburg Sentence Test in noise (S0 N±135)', 'timeFrame': 'immediately after the intervention', 'description': 'Speech perception in noise measured in dB SNR (the new Focused beamformer and the Natural beamformer are tested)'}, {'measure': 'Oldenburg Sentence Test in noise (S0 N±135)', 'timeFrame': 'immediately after the intervention', 'description': 'Speech perception in noise measured in dB SNR (theAI-Medium and the AI-Mild mode are tested)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cochlear implant', 'audiology'], 'conditions': ['Cochlear Implant Users']}, 'descriptionModule': {'briefSummary': 'Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced.\n\nThe focus of the study is on two new front-end features:\n\n* Focused Beamformer - Enhances directional hearing.\n* AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum age of eighteen (18) years at time of enrolment\n* Experienced MED-EL cochlear implant (CI) user (≥ 6 months) for the ear to be tested\n* User of a MED-EL Audio Processor (i.e. a SONNET, SONNET 2, SONNET 3, or RONDO 3 ≥ 3months)\n* Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested\n* A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB sound pressure level (SPL) for the ear to be tested (at the last time tested in clinical routine)\n* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)\n* Implanted with C40X, or C40C on the ear to be tested\n* Implanted with an auditory brainstem implant (ABI) or Split electrode array\n* Known allergic reactions to components of the investigational medical device\n* Anything that, in the opinion of the Investigator, would\n\n * place the subject at increased risk\n * preclude the subject's full compliance with or completion of the study"}, 'identificationModule': {'nctId': 'NCT07213505', 'acronym': 'M11S3', 'briefTitle': 'This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'MED-EL Elektromedizinische Geräte GesmbH'}, 'officialTitle': 'Investigating New Front-end Features in the SONNET 3', 'orgStudyIdInfo': {'id': 'MED-EL_CRD_2024_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los', 'description': 'Testing new versus approved front-end features (within subject design)', 'interventionNames': ['Other: Testing new front-end features']}], 'interventions': [{'name': 'Testing new front-end features', 'type': 'OTHER', 'description': 'New front-end features (i,e, the Focused Beamformer which nhances directional hearing and the AI Mode Medium (utilizes adaptive intelligence for optimized sound processing) will be compared to the approved beamformer and AI mode) in a within subject design. Subjects will be fitted with a MED-EL SONNET 3 audio processor.', 'armGroupLabels': ['Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Simone Univ.-Prof.in Dr.in med. Graf', 'role': 'CONTACT', 'phone': '+43 50 504 23147'}], 'facility': 'Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Sankt Pölten', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Astrid Priv.-Doz. OÄ Drin. med. univ. Magele, MBA', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MED-EL Elektromedizinische Geräte GesmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}