Design Improvements With SONNET 3

Not Applicable

Recruiting

• Conditions: Hearing Loss, Sensorineural

• Registration Number: NCT06597747
• Lead Sponsor: Med-El Corporation

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 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 Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Study Start: 2024-12-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Improved Design with SONNET 3 (EAS)	Measured 1 month after baseline	The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey will be calculated.

Secondary Outcome Measures

Name	Time	Method
Summary of Audiologist-Reported Satisfaction Ratings with SONNET 3 (EAS)	Measured at enrollment conclusion	Descriptive statistics will be used to summarize audiologist responses to survey questions.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States