Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
Cochlear
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation. * Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642). * Willing and able to provide written informed consent. Exclusion Criteria: * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator. * Additional disabilities that may affect the subject's participation or safety during the clinical…
Interventions
- DeviceCI632D
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
- DeviceCI632
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Locations (3)
- Rocky Mountain Ear CenterEnglewood, Colorado
- University of IowaIowa City, Iowa
- University Hospitals ClevelandCleveland, Ohio