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

NCT07213505 | Recruiting

• 1 other identifier: MED-EL_CRD_2024_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 the adaptive intelligence for optimized sound processing.

Conditions

Cochlear Implant Users

Keywords

cochlear implant; audiology

Outcome Measures

Primary Outcomes (1)

• Oldenburg Sentence Test in noise (S0 N±135)

  Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested)

  immediately after the intervention

Secondary Outcomes (2)

• Oldenburg Sentence Test in noise (S0 N±135)

  immediately after the intervention

• Oldenburg Sentence Test in noise (S0 N±135)

  immediately after the intervention

Study Arms (1)

Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los

EXPERIMENTAL

Testing new versus approved front-end features (within subject design)

Other: Testing new front-end features

Interventions

Testing new front-end features OTHER

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.

Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead
• Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten: collaborator
• Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen: collaborator

Study Sites (2)

Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen

Innsbruck, Austria

RECRUITING

Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen

Sankt Pölten, Austria

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: October 9, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)