Clinical Trial: Hybrid L24 New Enrollment Post Approval Study

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

Official Title: Nucleus Hybrid L24 Implant System: New Enrollment Study

Brief Summary: This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Detailed Summary:
Sponsor: Cochlear

Current Primary Outcome:

• CNC Word Recognition in Quiet [ Time Frame: 60 months post-activation ]
  The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study.
• AzBio Sentence Recognition in Noise [ Time Frame: 60 months post-activation ]
  The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cochlear

Dates:
Date Received: January 29, 2015
Date Started: February 2015
Date Completion: March 2022
Last Updated: March 28, 2017
Last Verified: March 2017