This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Co… (NCT07213505) | Clinical Trial Compass
CompletedNot Applicable
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Austria40 participantsStarted 2025-09-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.