| Registry | NCT01959152 |
|---|---|
| Status | Terminated |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 1 (Actual) |
| Sponsor | Advanced Bionics (Industry) |
| Conditions | Hearing Loss, Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases |
| Interventions | HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode (Device) |
| Dates | start 2013-10-01, primary completion 2014-09-01, completion 2014-11-01, first posted 2013-10-09, last updated 2015-05-21 |
| Locations | 3 sites in Canada |
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All trials for Hearing Loss All trials for Deafness All trials of HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
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 HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HiRes90K™ Advantage Cochlear Implant | Experimental | Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode | HiRes90K™ Advantage implant with HiFocus™ 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * No previous cochlear implant experience * 18 years of age or older * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted * Aided monosyllabic word score of 10-50% in the ear to be implanted * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear * English language proficiency * Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: * Previous inner ear surgery * Cochlear malformation or obstruction that would preclude full insertion of electrode array * Presence of additional disabilities that would prevent or interfere with participation in the required study procedures * Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures * Evidence of central auditory lesion or compromised auditory nerve
| Facility | City | Country | Status |
|---|---|---|---|
| Dalhousie University, Department of Surgery, Division of Otolaryngology | Halifax, Nova Scotia | Canada | |
| The Ottawa Hospital, Parkdale Clinic, Audiology Department | Ottawa, Ontario | Canada | |
| Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery | Toronto, Ontario | Canada |