Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
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.
Sensorineural Hearing Loss
|Study Design:||Observational Model: Case-Only|
- IT-MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- MLNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- LNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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
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