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Nucleus Hybrid L24 Extended Duration Post Approval Study — HED  

Hearing Loss Clinical Trial

Official title:
The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study

Clinical Trial Summary

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Clinical Trial Description

The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02379273
Study type Interventional
Source Cochlear
Contact
Status Completed
Phase N/A
Start date January 14, 2015
Completion date March 18, 2019
View Details
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