Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
52 participants
INTERVENTIONAL
2015-02-28
2022-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nucleus Hybrid L24 Extended Duration Post Approval Study
NCT02379273
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
NCT00678899
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
NCT01072409
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
NCT01975571
Evaluation of New Feedback Canceller for Carina™ Implant
NCT02309541
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nucleus Hybrid L24 Implant
Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Nucleus Hybrid L24 Implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nucleus Hybrid L24 Implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cochlear
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Kaplan, MD
Role: PRINCIPAL_INVESTIGATOR
Greater Baltimore Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Ear Center
Phoenix, Arizona, United States
Kaiser Permanente South Sacramento
Sacramento, California, United States
University of Colorado Hospitals
Aurora, Colorado, United States
Denver Ear Associates
Englewood, Colorado, United States
Rocky Mountain Ear Center
Englewood, Colorado, United States
University of Miami
Miami, Florida, United States
NorthShore University Health System
Northbrook, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Michigan Ear Institute
Farmington Hills, Michigan, United States
Midwest Ear Institute
Kansas City, Missouri, United States
The University of Cincinnati
Cincinnati, Ohio, United States
Ohio Ear Institute
Westerville, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ear Institute of Texas
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reinhart 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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAM-5573-HYB-PMA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.