Status:
RECRUITING
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Lead Sponsor:
Cochlear
Conditions:
Sensorineural Hearing Loss
Bilateral Hearing Loss
Eligibility:
All Genders
18+ years
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06936449
Start Date
May 5 2025
End Date
March 1 2028
Last Update
December 15 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106