NCT06598059

Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

A Pivotal, Prospective, Multicentre, Single-arm Study Evaluating the Safety and Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode Array (EA32D).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Cochlear implant	CI632D cochlear implant
DRUG	Dexamethasone	CI632D, dexamethasone-eluting cochlear implant

Timeline

• Start date: 2025-01-03
• Primary completion: 2026-02-02
• Completion: 2026-09-01
• First posted: 2024-09-19
• Last updated: 2026-03-02

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study