Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Purpose
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.
Conditions
- Sensorineural Hearing Loss
- Bilateral Hearing Loss
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 investigation. - Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator. - Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
Rocky Mountain Ear Center
Englewood, Colorado 80113
Englewood, Colorado 80113
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University Hospitals Cleveland
Cleveland, Ohio 44106
Cleveland, Ohio 44106
More Details
- Status
- Recruiting
- Sponsor
- Cochlear