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Post Approval Study: Longitudinal Monitoring of Newly Implanted Subjects with the Nucleus Hybrid L24 Cochlear Implant System
Primary Objective
To evaluate the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted individuals
Description
The visit dates for this study are a candidacy evaluation, a baseline evaluation, the Initial Activation, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Most of these visits will be at the same time as your clinical audiologist visits.
MoreDetails
Age
Adult
Eligibility
Eligibility criteria are if the participant would meet the Nucleus Hybrid L24 Implant System.
Phase
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Type of Study
Observational
Scope
National
Location
University of Colorado Hospital
Principal Investigator
Stephen Cass, MD, MPH/MSPH
Study ID
Protocol Number: 14-1927
ClinicalTrials.gov: NCT02379819
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