Hearing Loss, SensorineuralNCT06597747
Design Improvements With SONNET 3
A study testing Audio processor in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 1 site in United States.
Trial summary
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Audio processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Implanted with a MED-EL cochlear implant in at least one ear
- ≥ 12 months since activation of the MED-EL audio processor
- Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
- Ability to complete all study procedures
- Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study
Who cannot join
- Evidence that hearing loss is retrocochlear in origin
- Unable to provide reliable feedback during cochlear implant programming
- Skin or scalp condition precluding use of the study device
- Unrealistic participant or parent (if applicable) motivation or expectations
- Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27517
About this study
Official title: Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
Read the detailed description
This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Audio processor
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio processorDevice
MED-EL SONNET 3 (EAS) audio processor
| Study group | Role | What they receive |
|---|---|---|
| SONNET 3 (EAS) | Experimental | Participants complete a take-home trial using SONNET 3 (EAS) audio processor Receives: Device: Audio processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Reporting Improvement With SONNET 3 Design
The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
Measured: Measured 1 month after baseline
Secondary outcomes (1)
Audiologist Satisfaction Ratings
Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey.
Measured: Measured after study completion, an average of 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Dec 2024
- Primary completion22 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597747
- Sponsor's protocol ID
- G240188
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Group level results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT06597747
- Acronym / sponsor ID
- G240188
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
Detailed description
This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SONNET 3 (EAS) | Experimental | Device: Audio processorParticipants complete a take-home trial using SONNET 3 (EAS) audio processor |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Implanted with a MED-EL cochlear implant in at least one ear
- ≥ 12 months since activation of the MED-EL audio processor
- Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
- Ability to complete all study procedures
- Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study
Key exclusion criteria (5 listed)
- Evidence that hearing loss is retrocochlear in origin
- Unable to provide reliable feedback during cochlear implant programming
- Skin or scalp condition precluding use of the study device
- Unrealistic participant or parent (if applicable) motivation or expectations
- Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
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 |
|---|---|---|
| Audio processorMED-EL SONNET 3 (EAS) audio processor | Device | SONNET 3 (EAS) |
Primary outcome
Participants Reporting Improvement With SONNET 3 Design
Time frame: Measured 1 month after baseline
The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
1 secondary outcome
Audiologist Satisfaction Ratings
Time frame: Measured after study completion, an average of 7.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Group level results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio processor in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 1 site in United States.
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 5 inclusion and 5 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants Reporting Improvement With SONNET 3 Design (time frame: Measured 1 month after baseline). 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 31 Dec 2025.