NCT04750642

Cochlear Implant With Dexamethasone Eluting Electrode Array

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Detailed description

The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

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 (CI632D)
DEVICE	CI632	CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-07-07
• Completion: 2024-02-23
• First posted: 2021-02-11
• Last updated: 2025-04-22
• Results posted: 2025-04-22

Locations

8 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study