NCT06936449

Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 19 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sensorineural Hearing Loss
• Bilateral Hearing Loss

Interventions

Type	Name	Description
DEVICE	CI632D	CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
DEVICE	CI632	CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Timeline

• Start date: 2025-05-05
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-04-20
• Last updated: 2025-12-15

Locations

3 sites across 1 country: United States