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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimodal streaming | Experimental | Bimodal streaming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimodal Streaming Configuration | Device | Participants' devices are configured for bimodal streaming. Participants complete a survey following a trial with the new bimodal streaming feature. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idaho Ear Clinic | Meridian | Idaho | 83642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimodal Streaming | Bimodal streaming with DualSync bimodal streaming |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimodal Streaming | Bimodal streaming with DualSync bimodal streaming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population differs for questions on streaming music, media, and phone calls as not all participants streamed all forms of audio. | Posted | Count of Participants | Participants | 1 week |
|
|
From enrollment until completion of 1-week follow-up survey (approximately 1 week)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimodal Streaming | Bimodal streaming with DualSync bimodal streaming | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | MED-EL Corporation | 888-633-3524 | research.us@medel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2025 | Sep 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration of Cochlear Implant Experience | Months since activation of the cochlear implant | Median | Full Range | months |
|
| Participants |
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |