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| Name | Class |
|---|---|
| NAMSA | OTHER |
| LWB Consulting | UNKNOWN |
| Althea Anagnostopoulos Harrington | UNKNOWN |
| MV Clinical Research, LLC |
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This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear™ Nucleus® System | Experimental | Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear™ Nucleus® System | Device | The Cochlear™ Nucleus ® System is a commercially available system intended for restoration of hearing sensation through electrical stimulation of the auditory nerve in adult patients with bilateral symmetrical sensorineural hearing loss. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of device and procedure-related adverse events and serious adverse events | Events will be summarized by type, frequency, and severity. | 6-months post-activation |
| Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted | The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study. | Pre-operative baseline, 6 months post-activation |
| Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition | The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study. | Pre-operative baseline, 6 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of device and procedure related adverse events and serious adverse events | Events will be summarized by type, frequency, and severity. | 36-Months post-activation |
| Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Centre for Neurosciences |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| UNKNOWN |
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The SSQ12 is a self-administered questionnaire designed to measure auditory disability across three categories: speech perception, spatial hearing, and qualities of hearing. Respondents rate their perceived ability or experience for each scenario questioned on a 'ruler' (horizontal line) that is numbered, left to right, from '0' corresponding to no ability, to '10,' corresponding to complete ability. Higher scores represent greater ability. |
| Pre-operative baseline, 6 months post-activation |
| Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement | The THI is a 25-item self-assessment questionnaire used to assess the impact of tinnitus on a patient's quality of life. Items are grouped into functional, emotional, and catastrophic domains. A "yes" response is scored with 4 points; "sometimes" with 2 points; and "no" with zero points. Scores for the total scale range from 0 to 100 points, with higher scores representing greater perceived handicap. | Pre-operative baseline, 6 months post-activation |
| Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted | The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study. | Pre-operative baseline, 3 months post-activation |
| Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition | The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study. | Pre-operative baseline, 3 months post-activation |
| Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition | This will be evaluated for those participants who have a LFPTA (125-500 Hz) <80 dB HL versus those participants who have a LFPTA (125-500 Hz) ≥ 80 dB HL. | 6 months post-activation |
| Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition | This will be evaluated for those participants who have a LFPTA (125-500 Hz) <80 dB HL versus those participants who have a LFPTA (125-500 Hz) ≥ 80 dB HL. | 6 months post-activation |
| Tucson |
| Arizona |
| 85718 |
| United States |
| Pacific Neuroscience Institute | Santa Monica | California | 90404 | United States |
| University of Miami | Coral Gables | Florida | 33146 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64111 | United States |
| New York University | New York | New York | 10016 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Hospitals | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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