Improving design of a new audio processor for cochlear implant users
Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
This study tests how satisfied experienced cochlear implant users are with a new behind-the-ear audio processor compared to their current one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | Med-El Corporation Industry-sponsored |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06597747 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates user satisfaction with the latest behind-the-ear audio processor model among experienced cochlear implant users. Participants will wear the new MED-EL audio processor and complete a custom questionnaire to compare its design and usability against their current processor. The study employs a single-arm, repeated measures design, allowing participants to serve as their own control. This approach aims to gather direct feedback on the new device's performance and user experience.
Who should consider this trial
Good fit: Ideal candidates are individuals who have been implanted with a MED-EL cochlear implant for at least 12 months and are currently using a SONNET or SONNET 2 audio processor.
Not a fit: Patients with retrocochlear hearing loss or those unable to provide reliable feedback during programming may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced audio processing technology that improves the quality of life for individuals with hearing loss.
How similar studies have performed: While this specific approach is novel, similar studies evaluating user satisfaction with audio processors have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: MED-EL Corporation
- Email: research.us@medel.com
- Phone: 1-888-633-3524
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.