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A Pivotal, Prospective, Multicentre, Single-arm Study Evaluating the Safety and Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode Array (EA32D). (DEE-REX)
This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.
Details
| Lead sponsor | Cochlear |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 56 |
| Start date | 2025-01-03 |
| Completion | 2026-09 |
Conditions
- Hearing Loss
Interventions
- Cochlear implant
- Dexamethasone
Primary outcomes
- Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation — On day of implantation and at 1- and 3-months postactivation
Impedance will be measured across the active electrodes of the implant for each participant. - Coprimary endpoint 2: Mean change in word recognition score in the best unilateral listening mode in quiet from preimplantation to 3 months postactivation — Preoperative baseline and 3-months postactivation
Within-subject change in consonant-nucleus-consonant (CNC) words in quiet (% correct) calculated as the average across 2 runs of the test conducted on each participant. CNC word score ranges from 0-100%, higher the score the better the outcome.
Countries
United States