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Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SONNET 3 (EAS) | Experimental | Participants complete a take-home trial using SONNET 3 (EAS) audio processor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio processor | Device | MED-EL SONNET 3 (EAS) audio processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Reporting Improvement With SONNET 3 Design | The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey | Measured 1 month after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Audiologist Satisfaction Ratings | Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey. | Measured after study completion, an average of 7.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27517 | United States |
Group level results will be reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | SONNET 3 (EAS) | Participants complete a take-home trial using SONNET 3 (EAS) audio processor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SONNET 3 (EAS) | Participants complete a take-home trial using SONNET 3 (EAS) audio processor |
| 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 | Participants Reporting Improvement With SONNET 3 Design | The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey | Posted | Count of Participants | Participants | Measured 1 month after baseline |
|
|
Measured through study completion, an average of 7.5 months
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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 | SONNET 3 (EAS) | Participants complete a take-home trial using SONNET 3 (EAS) audio processor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Device Effect | Ear and labyrinth disorders | Non-systematic Assessment |
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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 | Aug 2, 2024 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
| Cochlear Implant Experience | Years since activation of cochlear implant | Mean | Standard Deviation | years |
|
|
| Secondary | Audiologist Satisfaction Ratings | Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey. | Posted | Mean | Standard Deviation | Score on 6-point Likert scale | Measured after study completion, an average of 7.5 months |
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| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |