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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| LWB Consulting | UNKNOWN |
| Althea Anagnostopoulos Harrington | UNKNOWN |
| MV Clinical Research, LLC |
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This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting electrode array (CI632D) | Experimental | Participants will be implanted with the slim modiolar dexamethasone-eluting electrode array. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Device | CI632D cochlear implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation | Impedance will be measured across the active electrodes of the implant for each participant. | On day of implantation and at 1- and 3-months postactivation |
| Coprimary endpoint 2: Mean change in word recognition score in the best unilateral listening mode in quiet from preimplantation to 3 months postactivation | Within-subject change in consonant-nucleus-consonant (CNC) words in quiet (% correct) calculated as the average across 2 runs of the test conducted on each participant. CNC word score ranges from 0-100%, higher the score the better the outcome. | Preoperative baseline and 3-months postactivation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean within-subject change in the global score of the Speech, Spatial, and Qualities of hearing scale (SSQ12) from preimplantation to postimplantation | Within-subject change in Global SSQ12 scores at 6-months postactivation compared with preoperative baseline. The global SSQ12 score ranges from 0-10, higher the score the better the outcome. | Preoperative baseline and 6-months postactivation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency throughout the study | Adverse events will be recorded as overall, by severity, by relatedness to device or procedure, or by seriousness. Device deficiency will be recorded as overall and by type. | From implantation to 12-months postimplantation (study end) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Parkinson, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Rocky Mountain Ear Center |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| UNKNOWN |
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| Dexamethasone | Drug | CI632D, dexamethasone-eluting cochlear implant |
|
|
| Mean within-subject change in sentence recognition score in the best unilateral listening mode in noise from preimplantation to postimplantation | Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome. | Preoperative baseline and 6-months postactivation |
| Mean within-subject change in sentence recognition score in the best bilateral listening mode in noise from preimplantation to postimplantation | Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome. | Preoperative baseline and 6-months postactivation |
| Englewood |
| Colorado |
| 80113 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Washington University | St Louis | Missouri | 63141 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10010 | United States |
| NYU Langone Health | New York | New York | 10017 | United States |
| Northwell Health Long Island Jewish Medical Center | New York | New York | 11042 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |