Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population
1 other identifier
observational
37
1 country
19
Brief Summary
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that expand criteria currently used by Center for Medicare \& Medicaid Services (CMS), and 2) to assess the correlation between measures of speech recognition in candidates for cochlear implants and their utility in predicting audiologic and quality of life outcomes after implantation. Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical insurance coverage. Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in a patient population that does not meet current CMS candidacy criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 21, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJuly 27, 2021
July 1, 2021
5.6 years
February 21, 2014
July 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months
A list of recorded sentences presented to subjects prior to receiving a cochlear implant while they use hearing aids. Subjects repeat each word of the sentence that they can understand and are given a percent correct score based on the percentage of words correctly understood. The test is administered again after receiving a cochlear implant to determine if their ability to recognize words in sentences has improved.
up to 12 months post-cochlear implant.
Secondary Outcomes (4)
CNC Word Test at Baseline/Pre-Surgery, 6 and 12 months
Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.
Health Utility Index Mark 3 (HUI3) Questionnaire at Baseline/Pre-Surgery, 6 and 12 months
Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.
Short Form Health Survey (SF-36) with utility transforms at Baseline/Pre-Surgery, 6 and 12 months
6 and 12 months post- cochlear implant.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.
Study Arms (2)
Group A
45 participants with AzBio baseline sentence scores between 41 - 50%
Group B
45 participants with AzBio baseline sentence scores between 51 - 60%.
Interventions
A cochlear implant consists of an implantable device that electrically stimulates surviving nerve fibers within the inner ear to produce perceptions of sound in patients with significant sensorineural hearing loss.. The implanted device is controlled by an external sound processor that converts acoustic sound signals into patterns of electrical stimulation that result in sound perception for the user.
Eligibility Criteria
This study will evaluate the benefits of cochlear implantation in up to 90 CMS-eligible (medicare) adults from up to 10 study sites in the North America.
You may qualify if:
- Sixty-five years of age or older at the time of the study and CMS-eligible as primary source of medical insurance coverage.
- Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high frequencies (3000 Hz and above).
- Preoperative aided sentence score in quiet greater than or equal to 40% correct but less than or equal to 60% correct in the best aided condition on recorded AzBio sentences.
- English spoken as the primary language.
You may not qualify if:
- Congenital hearing loss (for the purpose of this study, onset pror to 2 years-of-age).
- Preoperative aided sentence score less than 40% or greater than 60% correct in the best aided condition on AzBio sentences in quiet
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- Active middle-ear infection.
- The audiologist and/or surgeon will review the study protocol with the patient prior to having him/her sign the consent form. If the patient indicates he/she is unwilling or unable to comply with all investigational requirements, he/she will not be enrolled in the study.
- Using best clinical judgment based on professional interaction with the patient and his/her family, the managing audiologist and surgeon will determine if there are any disabling cognitive limitations that would prevent the patient from providing reliable data for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Cochlear Implant Alliancelead
- University of Michigancollaborator
- University of Iowacollaborator
- Johns Hopkins Universitycollaborator
- University of Miamicollaborator
- NYU Langone Healthcollaborator
- University of North Carolinacollaborator
- University of Southern Californiacollaborator
- Vanderbilt Universitycollaborator
- University of Washingtoncollaborator
- Washington University School of Medicinecollaborator
- Loyola University Chicagocollaborator
- University of Pennsylvaniacollaborator
- University of Texascollaborator
- Saint Luke's Health Systemcollaborator
- Massachusetts Eye and Ear Infirmarycollaborator
- Medical College of Wisconsincollaborator
- Medical University of South Carolinacollaborator
- Ohio State Universitycollaborator
- Rocky Mountain Ear Center Audiology and Ear Servicescollaborator
Study Sites (19)
University of Southern California, Department of Otolaryngology, Head & Neck Surgery
Los Angeles, California, 90033, United States
Rocky Mountain Ear Center
Englewood, Colorado, 80113, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Loyola University Medical Center - Department of Otolaryngology - Head and Neck Surgery
Chicago, Illinois, 60153, United States
University of Iowa, Otolaryngology-Head & Neck Surgery
Iowa City, Iowa, 52242, United States
Johns Hopkins Listening Center
Baltimore, Maryland, 21287, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
University of Michigan, Department of Otolaryngology, Head & Neck Surgery
Ann Arbor, Michigan, 48109, United States
St. Luke's Midwest Ear Institute
Kansas City, Missouri, 64111, United States
Washington University School of Medicine, Department of Otolaryngology, Head & Neck Surgery
St Louis, Missouri, 63110, United States
New York University Medical Center
New York, New York, 10016, United States
University of North Carolina at Chapel Hill, Department of Otolaryngology, Head & Neck Surgery
Chapel Hill, North Carolina, 27599, United States
The Ohio State University Medical Center
Columbus, Ohio, 43212, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Washington, Virginia Merrill Bloedel Hearing Research Center
Seattle, Washington, 98195, United States
Koss Cochlear Implant Program, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Zwolan TA, Kallogjeri D, Firszt JB, Buchman CA. Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):933-941. doi: 10.1001/jamaoto.2020.2286.
PMID: 32857106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa A Zwolan, Ph.D
University of Michigan & American Cochlear Implant Alliance
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director, University of Michigan Cochlear Implant Program
Study Record Dates
First Submitted
February 21, 2014
First Posted
March 3, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share