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Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP950 Sound Processor | Device | An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically:
| 1 month |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Englewood | Colorado | 80013 | United States | ||
| NYU |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software |
| 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 | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically:
| All enrolled subjects | Posted | Count of Participants | Participants | 1 month |
|
|
1 year
There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero.
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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 | Treatment Group | There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mircrophone housing | Product Issues | Intermittent sound processor. The adverse event was resolved by replacing the processor. The device was subsequently analyzed and found to have dislodged microphones from the housing. |
Short-term usability study, in a small population
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Nix, Clinical Project Manager | Cochlear Americas | 303-264-2340 | knix@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2016 | Aug 14, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Wireless programming pod | Device | The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software |
|
| New York |
| New York |
| 10523 |
| United States |
| Hearts for Hearing | Oklahoma City | Oklahoma | 73112 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
|
| Skin flap | Product Issues | Infection or swelling at implant site. August 30, 2016 was reported date of onset, and reported to the clinic on September 3, 2016. The adverse event was resolved on September 6, 2016 by antibiotic treatment. |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |