Nucleus Hybrid L24 Extended Duration Post Approval Study (HED)

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Nucleus Hybrid L24 Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02379273

CAM-5563-HYB-PMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Exclusion criteria

• Recipients who withdrew or were terminated from the L24 pivotal IDE study
• Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Hybrid L24 pivotal study subjects

Experimental group

Description:

Subjects implanted with the Nucleus Hybrid L24 Implant as part of the pivotal IDE study and who still have the device implanted will continue to be followed for 5 years post activation

Treatment:

Device: Nucleus Hybrid L24 Implant