Status:
RECRUITING
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsors:
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten
Conditions:
Cochlear Implant Users
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 percep...
Eligibility Criteria
Inclusion
- Minimum age of eighteen (18) years at time of enrolment
- Experienced MED-EL cochlear implant (CI) user (≥ 6 months) for the ear to be tested
- User of a MED-EL Audio Processor (i.e. a SONNET, SONNET 2, SONNET 3, or RONDO 3 ≥ 3months)
- Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
- 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)
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
Exclusion
- Lack of compliance with any inclusion criteria
- 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)
- Implanted with C40X, or C40C on the ear to be tested
- Implanted with an auditory brainstem implant (ABI) or Split electrode array
- Known allergic reactions to components of the investigational medical device
- Anything that, in the opinion of the Investigator, would
- place the subject at increased risk
- preclude the subject's full compliance with or completion of the study
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07213505
Start Date
September 29 2025
End Date
September 29 2026
Last Update
November 21 2025
Active Locations (2)
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1
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Innsbruck, Austria
2
Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen
Sankt Pölten, Austria