Status:
COMPLETED
Design Improvements With SONNET 3
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
7+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06597747
Start Date
December 16 2024
End Date
July 31 2025
Last Update
December 31 2025
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27517