Clinical Trial: CI532 - Early Experience Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study

Brief Summary: To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Detailed Summary: To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Sponsor: Cochlear

Current Primary Outcome: Speech understanding (% correct) on AzBio sentences in quiet in the implanted ear [ Time Frame: pre implantation to 3 months postactivation of the sound processor ]

To determine if unilateral listening performance at 3 months post activation with the CI532 will be superior to the best aided unilateral preoperative condition for sentence perception in quiet.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cochlear

Dates:
Date Received: April 19, 2016
Date Started: May 2016
Date Completion: June 2017
Last Updated: February 6, 2017
Last Verified: February 2017