Hybrid L24 New Enrollment Post Approval Study

Overview

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Full Title of Study: “Nucleus Hybrid L24 Implant System: New Enrollment Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 14, 2022

Interventions

  • Device: Nucleus Hybrid L24 Implant

Arms, Groups and Cohorts

  • Experimental: Nucleus Hybrid L24 Implant
    • Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
    • Time Frame: From pre-operatively through 3 years post-activation of the device
    • The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores.
  • Number of Device or Procedure Related Adverse Events
    • Time Frame: Up to 5 years post-activation of the device

Secondary Measures

  • Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
    • Time Frame: Pre-operatively, up to 3 years post-activation of the device
    • The AzBio Sentence Tests 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 toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

Participating in This Clinical Trial

Inclusion Criteria

Ear to Be Implanted:

  • Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted – CNC word recognition of 10-60% in the ear to be implanted Contralateral Ear: – Moderately severe to profound mid to high frequency hearing loss in the contralateral ear – CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct Exclusion Criteria:

  • not proficient in English – unwilling and/or unable to comply with the test protocol – deafness due to lesions of the acoustic nerve or central auditory pathway. – active middle-ear disease, with or without tympanic membrane perforation. – absence of cochlear development. – duration of severe to profound hearing loss of 30 years or greater

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cochlear
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brian Kaplan, MD, Principal Investigator, Greater Baltimore Medical Center

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