Not provided
Not provided
Not provided
Not provided
Not provided
FDA determination of Fox software as class III medical device, not CDSS.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - New Model | Experimental | Standardized programming and testing method |
|
| Group B - Traditional Model | Active Comparator | Traditional clinical model which is not standardized across clinical sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Education and Treatment Model | Other | Patients will have self directed equipment education and standardized programming approaches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time Spent With Audiologist | Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B). | 6 months post activation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Head and Neck Surgical Associates | Wichita Falls | Texas | 76310 | United States | ||
| Puget Sound ENT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A - New Model | Standardized programming and testing method Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches |
| FG001 | Group B - Traditional Model | Traditional clinical model which is not standardized across clinical sites Traditional Model: Standard clinical practice and education |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A - New Model | Standardized programming and testing method Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches |
| BG001 | Group B - Traditional Model |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Time Spent With Audiologist | Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B). | No subjects completed all required visits and data for primary endpoints were not collected due to study termination shortly after execution commenced. | Posted | 6 months post activation |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A - New Model | Standardized programming and testing method Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Chenier | Cochlear Limited | +14423254171 | lchenier@cochlear.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2019 | Sep 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2019 | Oct 7, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional Model | Other | Standard clinical practice and education |
|
| Edmonds |
| Washington |
| 98026 |
| United States |
Traditional clinical model which is not standardized across clinical sites Traditional Model: Standard clinical practice and education |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
Traditional clinical model which is not standardized across clinical sites
Traditional Model: Standard clinical practice and education
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Group B - Traditional Model | Traditional clinical model which is not standardized across clinical sites Traditional Model: Standard clinical practice and education | 0 | 2 | 0 | 2 | 0 | 2 |
The disclosure restriction on the PIs, no data was to be published prior to sponsor publishing. However, an agreement was in place with one site to provide presentation at upcoming conference for a poster presentation.
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |