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Sponsor decided to cancel the study prior to any subjects being enrolled/consented due to the lack of CMS coverage and an internal staffing shortage.
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The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI624 Slim 20 Electrode | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI624 Slim 20 Electrode | Device | Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize hearing performance of the CI624. | Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words. | 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Hearing and Balance | Jacksonville | Florida | 32256 | United States |
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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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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |