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Recruiting Not applicable NCT07213505

This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.

No applicable phase (e.g. observational)
Conditions: Cochlear Implant Users

Sponsor: MED-EL Elektromedizinische Geräte GesmbH

trial.available_in: БГ
Overview
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. The focus of the study is on two new front-end features: * Focused Beamformer - Enhances directional hearing. * AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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
Interventions
Testing new front-end features
OTHER
Locations 2
Austria (2)
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Innsbruck
Simone Univ.-Prof.in Dr.in med. Graf
Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen
Sankt Pölten
Astrid Priv.-Doz. OÄ Drin. med. univ. Magele, MBA
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.09.2025
Completion date
01.07.2026
Registry ID
NCT07213505
Source
clinicaltrials.gov
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