Cochlear Implant UsersM11S3NCT07213505
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
A study testing Testing new front-end features in people with Cochlear Implant Users, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant Users
- What is being tested?
- Testing new front-end features
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- 29 Sep 2025to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Austria2 sites
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Innsbruck
Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen
Sankt Pölten
About this study
Official title: Investigating New Front-end Features in the SONNET 3
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.
- Conditions
- Cochlear Implant Users
- Being tested
- Testing new front-end features
- Keywords
- cochlear implant, audiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing new front-end featuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los | Experimental | Testing new versus approved front-end features (within subject design) Receives: Other: Testing new front-end features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oldenburg Sentence Test in noise (S0 N±135)
Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested)
Measured: immediately after the intervention
Secondary outcomes (2)
Oldenburg Sentence Test in noise (S0 N±135)
Speech perception in noise measured in dB SNR (the new Focused beamformer and the Natural beamformer are tested)
Measured: immediately after the intervention
Oldenburg Sentence Test in noise (S0 N±135)
Speech perception in noise measured in dB SNR (theAI-Medium and the AI-Mild mode are tested)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start29 Sep 2025
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant UsersStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen, Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213505
- Sponsor's protocol ID
- MED-EL_CRD_2024_01
- Acronym
- M11S3
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating New Front-end Features in the SONNET 3
- ClinicalTrials.gov ID
- NCT07213505
- Acronym / sponsor ID
- M11S3 / MED-EL_CRD_2024_01
- Conditions
- Cochlear Implant Users
- Keywords
- cochlear implant, audiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen, Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los | Experimental | Other: Testing new front-end featuresTesting new versus approved front-end features (within subject design) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing new front-end featuresNew 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. | Other | Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los |
Primary outcome
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)
2 secondary outcomes
Oldenburg Sentence Test in noise (S0 N±135)
Time frame: immediately after the intervention
Oldenburg Sentence Test in noise (S0 N±135)
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant Users
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruiting
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
Cochlear Implant, Cochlear Implant Users
Recruiting
Assessment of a Method to Improve Cochlear Implant Users' Speech Perception in Noisy Environments While Maintaining Their Ability to Determine Where a Sound Originates From
Cochlear Implant Users
Recruiting
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
Cochlear Implant Users
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing new front-end features in people with Cochlear Implant Users, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oldenburg Sentence Test in noise (S0 N±135) (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.