Clinical Trial

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

Study acronym: M11S3
Completed
View on ClinicalTrials.gov →
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 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.
Protocol Amendment History 1 change
critical Trial completed 2026-06-13
Trial Details
NCT Number NCT07213505
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Collaborators: Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen, Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten
Conditions Cochlear Implant Users
Enrollment 40 participants
Start Date 2025-09-29
Primary Completion 2026-06-11 (estimated)
Study Completion 2026-06-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-12