NCT02905305

Cochlear Implant With Anti-Inflammatory Agent

Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: The Hearing Cooperative Research Centre · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device. In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Contour Advance electrode with controlled dose of dexamethasone base	The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
DEVICE	Contour Advance electrode	Standard Contour Advance electrode

Timeline

• Start date: 2013-09-10
• Primary completion: 2017-11-06
• Completion: 2018-03-15
• First posted: 2016-09-19
• Last updated: 2021-07-06

Locations

1 site across 1 country: Australia