Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids

NCT07028619 | Completed Results FDA Device

• 1 other identifier: US2501
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL cochlear implant and Starkey hearing aid.

Conditions

Hearing Loss, Sensorineural; Sensorineural Hearing Loss, Bilateral; Cochlear Implant Recipients; Asymmetric Hearing Loss

Keywords

cochlear implants

Outcome Measures

Primary Outcomes (1)

• User Satisfaction With DualSync Bimodal Streaming Over Existing Bluetooth Streaming Option.

  Percentage of participants who reported improvement in subjective listening experience with DualSync bimodal streaming at 1-week. Responses taken from a user survey administered after 1-week with DualSync bimodal streaming.

  1 week

Study Arms (1)

Bimodal streaming

EXPERIMENTAL

Bimodal streaming

Device: Bimodal Streaming Configuration

Interventions

Bimodal Streaming Configuration DEVICE

Participants' devices are configured for bimodal streaming. Participants complete a survey following a trial with the new bimodal streaming feature.

Bimodal streaming

Eligibility Criteria

• 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 one ear
• Using an AudioKey compatible MED-EL audio processor
• Using an AudioKey compatible Starkey hearing aid
• If not using a SONNET 3 audio processor, has access to a MED-EL streaming device
• Using a smartphone that can support the AudioKey application
• Able to complete a survey via cellphone or computer
• Prior experience with Bluetooth streaming or expressed motivation to Bluetooth stream to hearing devices
• Ability to complete all study procedures including provide responses to survey questions

You may not qualify if:

• Unable to provide reliable feedback
• Unable to operate a smartphone with or without assistance

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (1)

Idaho Ear Clinic

Meridian, Idaho, 83642, 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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 26, 2025
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2025-09

Locations

US (1)