Hybrid L24 New Enrollment Post Approval Study (HNE)

Nucleus Hybrid L24 Implant System: New Enrollment Study

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

Study Overview

• Status: Completed
• Conditions: High Frequency Sensorineural Hearing Loss
• Intervention / Treatment: Device: Nucleus Hybrid L24 Implant

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Ear Center
  • California
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospitals
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Ear Center
    • Englewood, Colorado, United States, 80110
      • Denver Ear Associates
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Northshore University Health System
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Lahey Hospital and Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Ear Institute
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Midwest Ear Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The University of Cincinnati
    • Westerville, Ohio, United States, 43082
      • Ohio Ear Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh Ear Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78258
      • Ear Institute of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nucleus Hybrid L24 Implant; Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.	Device: Nucleus Hybrid L24 Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	From pre-operatively through 3 years post-activation of the device
Number of Device or Procedure Related Adverse Events		Up to 5 years post-activation of the device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition	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.	Pre-operatively, up to 3 years post-activation of the device

Collaborators and Investigators

• Sponsor: Cochlear
• Investigators: Principal Investigator: Brian Kaplan, MD, Greater Baltimore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): April 14, 2022
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: CAM-5573-HYB-PMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes