New beamformer and AI sound modes for MED-EL cochlear implant users
Investigating New Front-end Features in the SONNET 3
Researchers will test two new sound-processing features—Focused Beamformer and AI Mode Medium—in adult MED-EL cochlear implant users to see if they help hearing in noisy environments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Locations | 2 sites (Innsbruck and 1 other locations) |
| Trial ID | NCT07213505 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adult, experienced MED-EL cochlear implant users to try two new front-end processor features: a Focused Beamformer to enhance directional hearing and an AI Mode Medium for adaptive sound processing. Eligible participants must have used their MED-EL audio processor for at least three months and meet minimum speech-recognition criteria, while several implant types and better contralateral hearing are excluded. The features will be applied on participants' processors and performance and safety will be measured, with emphasis on speech understanding in background noise and any device-related issues. The work is carried out at collaborating ENT departments in Innsbruck and Sankt Pölten, Austria.
Who should consider this trial
Good fit: Adults (≥18 years) who are post-lingually deafened, have used a MED-EL cochlear implant in the test ear for ≥6 months, use a SONNET/SONNET 2/SONNET 3 or RONDO 3 processor for ≥3 months, and have ≥40% Freiburg monosyllable scores are the ideal candidates.
Not a fit: People with good hearing in the opposite ear (contralateral pure-tone average ≤30 dB), those implanted with excluded devices (C40X/C40C, ABI, or split electrode arrays), or those who do not meet the device-use or speech-score requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these features could improve speech understanding in noisy settings for MED-EL cochlear implant users.
How similar studies have performed: Previous beamforming and AI-based noise-reduction work in hearing aids and cochlear processors has shown promise for improving signal-to-noise listening, though outcomes depend on specific algorithms and device implementations.
Eligibility criteria
Show full inclusion / exclusion 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. 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
Where this trial is running
Innsbruck and 1 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.