Design Improvements With SONNET 3

December 10, 2025 updated by: Med-El Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SONNET 3 (EAS)
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
Device: Audio processor
MED-EL SONNET 3 (EAS) audio processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured 1 month after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiologist Satisfaction Ratings
Time Frame: Measured after study completion, an average of 7.5 months
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 after study completion, an average of 7.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G240188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Group level results will be reported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss, Sensorineural

Clinical Trials on Audio processor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe