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Completed

NCT Number: NCT07213505

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

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.

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Key information

Conditions

Cochlear Implant Users

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oldenburg Sentence Test in noise (S0 N±135)

    Time frame: immediately after the intervention

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

Secondary outcomes

  1. Oldenburg Sentence Test in noise (S0 N±135)

    Time frame: immediately after the intervention

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

  2. Oldenburg Sentence Test in noise (S0 N±135)

    Time frame: immediately after the intervention

    Speech perception in noise measured in dB SNR (theAI-Medium and the AI-Mild mode are tested)

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Collaborators

  • Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
  • Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten

Registry information

Official study title

Investigating New Front-end Features in the SONNET 3

Acronym: M11S3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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