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Nucleus Hybrid L24 Extended Duration Post Approval Study (HED)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nucleus Hybrid L24 Implant
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hybrid L24 pivotal study subjects

    Arm 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

    Outcomes

    Primary Outcome Measures

    Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
    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).
    AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2015
    Last Updated
    October 31, 2021
    Sponsor
    Cochlear
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379273
    Brief Title
    Nucleus Hybrid L24 Extended Duration Post Approval Study
    Acronym
    HED
    Official Title
    The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 14, 2015 (Actual)
    Primary Completion Date
    March 18, 2019 (Actual)
    Study Completion Date
    March 18, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cochlear
    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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hybrid L24 pivotal study subjects
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Device
    Intervention Name(s)
    Nucleus Hybrid L24 Implant
    Intervention Description
    Subjects have already been implanted with the Nucleus Hybrid L24 implant.
    Primary Outcome Measure Information:
    Title
    Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
    Description
    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).
    Time Frame
    5 years postactivation.
    Title
    AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
    Description
    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).
    Time Frame
    5 years postactivation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruce J Gantz, MD
    Organizational Affiliation
    University of Iowa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29330858
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Nucleus Hybrid L24 Extended Duration Post Approval Study

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