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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

Study category: Ear, Nose, and Throat

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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.

Details
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

Stephen Cass, MD, MPH/MSPH

Study ID

Protocol Number: 14-1927

More information available at ClinicalTrials.gov: NCT02379819

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