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| Name | Class |
|---|---|
| NAMSA | OTHER |
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The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children and adults with unilateral hearing loss/single-sided deafness | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Cochlear™ Nucleus® Cochlear Implant (CI) System | Device | The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations. | Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear. | pre-implantation, 12 months post-activation |
| Number of procedure and device related adverse events classified by type, frequency and severity. | 36 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings. | Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities. | pre-implantation, 12 months post-activation |
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Inclusion Criteria:
• Individuals 18 years or older (Group A)
Ear to be Implanted:
Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
• Children 5 years to 17 years, 11 months (Group B)
Ear to be Implanted:
Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Contact | +612294286555 | cltd-prs-admin@cochlear.com |
| Name | Affiliation | Role |
|---|---|---|
| Jillian Crosson | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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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| Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone. | Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better. | pre-implantation, 12 months post-activation |
| Rocky Mountain Ear Center | Recruiting | Englewood | Colorado | 80113 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| New York Eye and Ear Infirmary | Recruiting | New York | New York | 10003 | United States |
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| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27517 | United States |
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| Nationwide Children's Hospital | Withdrawn | Columbus | Ohio | 43205 | United States |
| University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery | Withdrawn | Dallas | Texas | 75390 | United States |
| Virginia Mason Medical Center | Recruiting | Seattle | Washington | 98101 | United States |
|
| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| 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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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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