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

Not Applicable

Not yet recruiting

• Conditions: Cochlear Implant Users

• Registration Number: NCT07213505
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

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 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 artificial intelligence for optimized sound processing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-25
• Study Start: 2025-09-30
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oldenburg Sentence Test in noise (S0 N±135)	immediately after the intervention	Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested)

Secondary Outcome Measures

Name	Time	Method
Oldenburg Sentence Test in noise (S0 N±135)	immediately after the intervention	Speech perception in noise measured in dB SNR (theAI-Medium and the AI-Mild mode are tested)

Trial Locations

Locations (2)

Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen; 🇦🇹 Innsbruck, Austria

Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen; 🇦🇹 Sankt Pölten, Austria