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A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: CI632D Investigational Medical Device (IMD) | Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant |
| |
| Active Comparator: CI632 Comparator Device | Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI632D | Device | CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits. | 5 years post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation. | 5 years post-activation | |
| Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals available from those sites invited to participate in the study consisting of up to 10 subjects implanted with the CI632D and up to 9 subjects with the CI632 in the CIDEX study (NCT04750642)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Contact | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Recruiting | Englewood | Colorado | 80113 | United States |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| CI632 | Device | CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone |
|
| 5 years post-activation |
| Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation. | 5 years post-activation |
| Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. | 5 years post-activation |
| Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation. | 5 years post-activation |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| University Hospitals Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |