This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients. (M11S3)

MED-EL

Status: Enrolling

Conditions: Cochlear Implant Users

Treatments: Other: Testing new front-end features

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07213505

MED-EL_CRD_2024_01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Other: Testing new front-end features