Hearing Loss, SensorineuralNCT07028619
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
A study testing Bimodal Streaming Configuration in people with Hearing Loss, Sensorineural and Sensorineural Hearing Loss, Bilateral, run by Med-El Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients
- What is being tested?
- Bimodal Streaming Configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to 18 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide reliable feedback
- Unable to operate a smartphone with or without assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early User Experience With the AudioKey Application and Starkey Hearing Aids
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.
Read the 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.
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Being tested
- Bimodal Streaming Configuration
- Keywords
- cochlear implants
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimodal Streaming ConfigurationDevice
Participants' devices are configured for bimodal streaming. Participants complete a survey following a trial with the new bimodal streaming feature.
| Study group | Role | What they receive |
|---|---|---|
| Bimodal streaming | Experimental | Bimodal streaming Receives: Device: Bimodal Streaming Configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start26 Jun 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028619
- Sponsor's protocol ID
- US2501
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early User Experience With the AudioKey Application and Starkey Hearing Aids
- ClinicalTrials.gov ID
- NCT07028619
- Acronym / sponsor ID
- US2501
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Keywords
- cochlear implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimodal streaming | Experimental | Device: Bimodal Streaming ConfigurationBimodal streaming |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide reliable feedback
- Unable to operate a smartphone with or without assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimodal Streaming ConfigurationParticipants' devices are configured for bimodal streaming. Participants complete a survey following a trial with the new bimodal streaming feature. | Device | Bimodal streaming |
Primary outcome
User Satisfaction With DualSync Bimodal Streaming Over Existing Bluetooth Streaming Option.
Time frame: 1 week
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimodal Streaming Configuration in people with Hearing Loss, Sensorineural and Sensorineural Hearing Loss, Bilateral, run by Med-El Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Satisfaction With DualSync Bimodal Streaming Over Existing Bluetooth Streaming Option. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.