Hybrid L24 New Enrollment Post Approval Study
HNE
Nucleus Hybrid L24 Implant System: New Enrollment Study
1 other identifier
interventional
52
1 country
19
Brief Summary
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2022
CompletedResults Posted
Study results publicly available
March 13, 2023
CompletedMarch 13, 2023
February 1, 2023
7.2 years
January 29, 2015
February 7, 2023
March 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
Pre-operatively, up to 3 years post-activation of the device
Study Arms (1)
Nucleus Hybrid L24 Implant
EXPERIMENTALAdults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (19)
Arizona Ear Center
Phoenix, Arizona, 85004, United States
Kaiser Permanente South Sacramento
Sacramento, California, 95823, United States
University of Colorado Hospitals
Aurora, Colorado, 80045, United States
Denver Ear Associates
Englewood, Colorado, 80110, United States
Rocky Mountain Ear Center
Englewood, Colorado, 80113, United States
University of Miami
Miami, Florida, 33136, United States
NorthShore University Health System
Northbrook, Illinois, 60062, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01803, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Michigan Ear Institute
Farmington Hills, Michigan, 48334, United States
Midwest Ear Institute
Kansas City, Missouri, 64111, United States
The University of Cincinnati
Cincinnati, Ohio, 45219, United States
Ohio Ear Institute
Westerville, Ohio, 43082, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Ear Institute of Texas
San Antonio, Texas, 78258, United States
Related Publications (2)
Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2025 Oct 8. doi: 10.1002/lary.70195. Online ahead of print.
PMID: 41059917DERIVEDReinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305.
PMID: 39514431DERIVED
Results Point of Contact
- Title
- PRS Specialist, Clinical Affairs
- Organization
- Cochlear
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Kaplan, MD
Greater Baltimore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
March 5, 2015
Study Start
February 1, 2015
Primary Completion
April 14, 2022
Study Completion
April 14, 2022
Last Updated
March 13, 2023
Results First Posted
March 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
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.