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Nucleus Hybrid L24 Extended Duration Post Approval Study

NCT ID: NCT02379273

Last Updated: 2021-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-14

Study Completion Date

2019-03-18

Brief Summary

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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

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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

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hybrid L24 pivotal study subjects

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

Group Type EXPERIMENTAL

Nucleus Hybrid L24 Implant

Intervention Type DEVICE

Subjects have already been implanted with the Nucleus Hybrid L24 implant.

Interventions

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Nucleus Hybrid L24 Implant

Subjects have already been implanted with the Nucleus Hybrid L24 implant.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

Midwest Ear Institute

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

The Center for Hearing and Balance Disorders

AMBIG

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Hearts for Hearing

OTHER

Sponsor Role collaborator

Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce J Gantz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

References

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Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2025 Oct 8. doi: 10.1002/lary.70195. Online ahead of print.

Reference Type DERIVED
PMID: 41059917 (View on PubMed)

Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.

Reference Type DERIVED
PMID: 29330858 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CAM-5563-HYB-PMA

Identifier Type: -

Identifier Source: org_study_id