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

NCT ID: NCT07213505

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2026-09-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Testing new front-end features

Intervention Type: 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.

Interventions

Testing new front-end features

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten

UNKNOWN

Sponsor Role: collaborator

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Innsbruck, , Austria

Site Status: RECRUITING

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

Sankt Pölten, , Austria

Site Status: NOT_YET_RECRUITING

Countries

Austria

Facility Contacts

Simone Univ.-Prof.in Dr.in med. Graf

Role: primary

+43 50 504 23147

Astrid Priv.-Doz. OÄ Drin. med. univ. Magele, MBA

Role: primary

Other Identifiers

MED-EL_CRD_2024_01

Identifier Type: -

Identifier Source: org_study_id