Sensorineural Hearing Loss Clinical Trial
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.
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
;
Observational Model: Case-Only
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