Clinical Trial: Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

Brief Summary: The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.

Detailed Summary:

The proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of age, implanted at up to 5 sites in the United States and Canada. The estimated duration of this multisite study is 18 to 24 months. The duration of individual subject participation is not to exceed 12 months.

The study will be conducted as a within-subject repeated measures experiment (in which each subject serves as his or her own control) in order to accommodate the heterogeneity that is well known to characterize hearing-impaired populations


Sponsor: Cochlear

Current Primary Outcome:

  • IT-MAIS [ Time Frame: 12 Months ]
  • MAIS [ Time Frame: 12 Months ]
  • MLNT [ Time Frame: 12 Months ]
  • LNT [ Time Frame: 12 Months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cochlear

Dates:
Date Received: December 23, 2007
Date Started: October 2006
Date Completion:
Last Updated: August 7, 2014
Last Verified: August 2014