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

Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early User Experience With the AudioKey Application and Starkey Hearing Aids

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07028619
Enrollment
10
Registered
2025-06-19
Start date
2025-06-26
Completion date
2025-09-18
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cochlear implants

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.

Detailed description

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.

Interventions

DEVICEBimodal Streaming Configuration

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

Sponsors

Med-El Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
User Satisfaction With DualSync Bimodal Streaming Over Existing Bluetooth Streaming Option.1 weekPercentage 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.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous67.4 years
STANDARD_DEVIATION 13.9
Duration of Cochlear Implant Experience3.2 months
Region of Enrollment
United States
10 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026