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Trial record 1 of 3 for:    Nucleus® Hybrid™ L24 Implant System:
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Nucleus Hybrid L24 Extended Duration Post Approval Study (HED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379273
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborators:
University of Iowa
NYU Langone Health
Midwest Ear Institute
University of Cincinnati
The Center for Hearing and Balance Disorders
Ohio State University
Mayo Clinic
Hearts for Hearing
Information provided by (Responsible Party):
Cochlear

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Nucleus Hybrid L24 Implant Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study
Actual Study Start Date : January 14, 2015
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: Nucleus Hybrid L24 Implant
Subjects have already been implanted with the Nucleus Hybrid L24 implant.


Outcome Measures
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Primary Outcome Measures :
  1. Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. [ Time Frame: 5 years postactivation. ]
    The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).

  2. AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. [ Time Frame: 5 years postactivation. ]
    The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379273


Sponsors and Collaborators
Cochlear
University of Iowa
NYU Langone Health
Midwest Ear Institute
University of Cincinnati
The Center for Hearing and Balance Disorders
Ohio State University
Mayo Clinic
Hearts for Hearing
Investigators
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Principal Investigator: Bruce J Gantz, MD University of Iowa
  Study Documents (Full-Text)

Documents provided by Cochlear:
Study Protocol  [PDF] September 9, 2014
Statistical Analysis Plan  [PDF] April 17, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02379273    
Other Study ID Numbers: CAM-5563-HYB-PMA
First Posted: March 4, 2015    Key Record Dates
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases