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Hybrid L24 New Enrollment Post Approval Study (HNE)

Primary Purpose

High Frequency Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
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 High Frequency Sensorineural Hearing Loss

Eligibility Criteria

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

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

Sites / Locations

  • Arizona Ear Center
  • Kaiser Permanente South Sacramento
  • University of Colorado Hospitals
  • Denver Ear Associates
  • Rocky Mountain Ear Center
  • University of Miami
  • NorthShore University Health System
  • University of Iowa
  • Greater Baltimore Medical Center
  • Lahey Hospital and Medical Center
  • University of Michigan
  • Michigan Ear Institute
  • Midwest Ear Institute
  • The University of Cincinnati
  • Ohio Ear Institute
  • Hospital of the University of Pennsylvania
  • Pittsburgh Ear Associates
  • Vanderbilt University Medical Center
  • Ear Institute of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nucleus Hybrid L24 Implant

Arm Description

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

Outcomes

Primary Outcome 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
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

Secondary Outcome Measures

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.

Full Information

First Posted
January 29, 2015
Last Updated
March 10, 2023
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02379819
Brief Title
Hybrid L24 New Enrollment Post Approval Study
Acronym
HNE
Official Title
Nucleus Hybrid L24 Implant System: New Enrollment Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Frequency Sensorineural 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
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nucleus Hybrid L24 Implant
Arm Type
Experimental
Arm Description
Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Intervention Type
Device
Intervention Name(s)
Nucleus Hybrid L24 Implant
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From pre-operatively through 3 years post-activation of the device
Title
Number of Device or Procedure Related Adverse Events
Time Frame
Up to 5 years post-activation of the device
Secondary Outcome Measure Information:
Title
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
Description
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.
Time Frame
Pre-operatively, up to 3 years post-activation of the device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kaplan, MD
Organizational Affiliation
Greater Baltimore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Ear Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Kaiser Permanente South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
University of Colorado Hospitals
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Ear Associates
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NorthShore University Health System
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01803
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Ear Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio Ear Institute
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pittsburgh Ear Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Ear Institute of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Hybrid L24 New Enrollment Post Approval Study

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