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New cochlear implant features aim to cut through noise

NCT ID NCT07213505

Symptom relief Sponsor: MED-EL Elektromedizinische Geräte GesmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two new features in the MED-EL SONNET 3 audio processor for cochlear implant users: the Focused Beamformer, which improves directional hearing, and the AI Mode Medium, which uses adaptive intelligence to optimize sound processing. Forty experienced cochlear implant users participated to see if these features help them understand speech better in noisy settings. The goal is to make hearing in challenging environments easier for people with hearing loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
new front-end features (Focused Beamformer and AI Mode Medium) in the MED-EL SONNET 3 audio processor
What this could lead to
If successful, these features could help cochlear implant users hear better in noisy environments, making conversations easier in places like restaurants or parties.
What could go wrong
This is a small, completed study with only 40 participants, so results may not apply to all users. The improvements are incremental and may not be noticeable in everyday life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

sensorineural hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cochlear implant users

Contacts and locations

Locations

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

    Innsbruck, Austria

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

    Sankt Pölten, Austria

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