Design Improvements With SONNET 3

NCT06597747 | Completed Results FDA Device

• 1 other identifier: G240188
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Participants Reporting Improvement With SONNET 3 Design

  The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey

  Measured 1 month after baseline

Secondary Outcomes (1)

• Audiologist Satisfaction Ratings

  Measured after study completion, an average of 7.5 months

Study Arms (1)

SONNET 3 (EAS)

EXPERIMENTAL

Participants complete a take-home trial using SONNET 3 (EAS) audio processor

Device: Audio processor

Interventions

Audio processor DEVICE

MED-EL SONNET 3 (EAS) audio processor

SONNET 3 (EAS)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Research Manager
• Organization: MED-EL Corporation

research.us@medel.com

888-633-3524

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: December 16, 2024
• Primary Completion: May 22, 2025
• Study Completion: July 31, 2025
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)