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

NCT ID: NCT07028619

Last Updated: 2026-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2025-09-18

Brief Summary

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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.

Detailed Description

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MED-EL cochlear implant recipients who use a compatible Starkey hearing aid in the other ear will evaluate a new Bluetooth streaming option that will directly stream audio from their iOS smart device to both hearing devices. A survey will be completed after a trial with the new streaming option.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bimodal streaming

Bimodal streaming

Group Type EXPERIMENTAL

Bimodal Streaming Configuration

Intervention Type DEVICE

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

Interventions

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Bimodal Streaming Configuration

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Unable to provide reliable feedback
* Unable to operate a smartphone with or without assistance
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Med-El Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Idaho Ear Clinic

Meridian, Idaho, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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US2501

Identifier Type: -

Identifier Source: org_study_id

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