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Design Improvements With SONNET 3 | Clinical Trials | Clareo Health

COMPLETEDNA

Design Improvements With SONNET 3

Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users

NCT06597747•Med-El Corporation

View on ClinicalTrials.gov

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 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.

Eligibility

Age

7 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of North Carolina

Chapel Hill, North Carolina, United States

Key Dates

Start Date

December 16, 2024

Primary Completion Date

May 22, 2025

Completion Date

July 31, 2025

Last Updated

December 31, 2025

Enrollment

ACTUAL participants

Conditions

Hearing Loss, Sensorineural

Interventions

Audio processor

DEVICE

Preschool Hearing Screening

NCT06058767

Hearing LossHearing Disorders in Children+6 more

View study

RECRUITINGNA

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

NCT06642935

Hearing Loss, Bilateral or UnilateralHearing Loss, Sensorineural+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Design Improvements With SONNET 3

Inclusion Criteria

Exclusion Criteria

Preschool Hearing Screening

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

Post-Market Clinical Investigation of the IotaSOFT Insertion System