NCT02379273

Nucleus Hybrid L24 Extended Duration Post Approval Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Nucleus Hybrid L24 Implant	Subjects have already been implanted with the Nucleus Hybrid L24 implant.

Timeline

• Start date: 2015-01-14
• Primary completion: 2019-03-18
• Completion: 2019-03-18
• First posted: 2015-03-04
• Last updated: 2021-11-30
• Results posted: 2021-11-30