Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population

Completed

Conditions studied: Bilateral Sensorineural Hearing Loss

In brief

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.

Key facts

Study ID

NCT02075229

Run by

American Cochlear Implant Alliance

People needed

37

Starts

2014-02-01

Expected to finish

2019-09-01

Last updated by the study team

2021-07-27

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• University of Southern California, Department of Otolaryngology, Head & Neck Surgery — Los Angeles, California, United States
• Rocky Mountain Ear Center — Englewood, Colorado, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Loyola University Medical Center - Department of Otolaryngology - Head and Neck Surgery — Chicago, Illinois, United States
• University of Iowa, Otolaryngology-Head & Neck Surgery — Iowa City, Iowa, United States
• Johns Hopkins Listening Center — Baltimore, Maryland, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• University of Michigan, Department of Otolaryngology, Head & Neck Surgery — Ann Arbor, Michigan, United States
• St. Luke's Midwest Ear Institute — Kansas City, Missouri, United States
• Washington University School of Medicine, Department of Otolaryngology, Head & Neck Surgery — St Louis, Missouri, United States
• New York University Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill, Department of Otolaryngology, Head & Neck Surgery — Chapel Hill, North Carolina, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt Bill Wilkerson Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Washington, Virginia Merrill Bloedel Hearing Research Center — Seattle, Washington, United States
• Koss Cochlear Implant Program, Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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