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The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiResâ„¢ 90K Advantage implant with HiFocusâ„¢ Mid-Scala electrode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HiRes90Kâ„¢ Advantage Cochlear Implant | Experimental | HiRes90Kâ„¢ Advantage implant with HiFocusâ„¢ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiResâ„¢ 90K Advantage implant with HiFocusâ„¢ Mid-Scala electrode | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocusâ„¢ Mid-Scala electrode array | Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as:
| One month |
| Measure | Description | Time Frame |
|---|---|---|
| Word recognition in quiet pre and post implantation with the HiFocusâ„¢ Mid-Scala electrode array | Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid | One month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalhousie University, Department of Surgery, Division of Otolaryngology | Halifax | Nova Scotia | B3H 2Y9 | Canada | ||
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| The Ottawa Hospital, Parkdale Clinic, Audiology Department |
| Ottawa |
| Ontario |
| K1Y 4E9 |
| Canada |
| Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery | Toronto | Ontario | M4N 3M5 | Canada |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003638 | Deafness |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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