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

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ClinicalTrials.gov Identifier: NCT02075229
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
University of Michigan
University of Iowa
Johns Hopkins University
University of Miami
New York University School of Medicine
University of North Carolina
University of Southern California
Vanderbilt University
University of Washington
Washington University School of Medicine
Loyola University Chicago
University of Pennsylvania
University of Texas
Saint Luke's Health System
Massachusetts Eye and Ear
Medical College of Wisconsin
Medical University of South Carolina
Ohio State University
Rocky Mountain Ear Center
Information provided by (Responsible Party):
Teresa A. Zwolan, PhD, American Cochlear Implant Alliance

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.


Condition or disease Intervention/treatment
Bilateral Sensorineural Hearing Loss Device: Cochlear implant

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population
Study Start Date : February 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group A
45 participants with AzBio baseline sentence scores between 41 - 50%
Device: Cochlear implant
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.
Group B
45 participants with AzBio baseline sentence scores between 51 - 60%.
Device: Cochlear implant
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.



Primary Outcome Measures :
  1. AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months [ Time Frame: up to 12 months post-cochlear implant. ]
    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.


Secondary Outcome Measures :
  1. CNC Word Test at Baseline/Pre-Surgery, 6 and 12 months [ Time Frame: Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant. ]
    Similar to the HINT sentences test, but instead a list of recorded one-syllable words are presented. The test is administered prior to and after receiving a cochlear implant to determine if their ability to recognize one syllable words has improved.

  2. Health Utility Index Mark 3 (HUI3) Questionnaire at Baseline/Pre-Surgery, 6 and 12 months [ Time Frame: Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant. ]
    The HUI is a family of generic health profiles and preference-based systems that measure health status and health-related quality of life.

  3. Short Form Health Survey (SF-36) with utility transforms at Baseline/Pre-Surgery, 6 and 12 months [ Time Frame: 6 and 12 months post- cochlear implant. ]
    This is a multi-purpose short-form health survey that provides an 8 scale profile of functional health and wellbeing as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index using utility transforms.

  4. Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant. ]
    This is a 24 item self-assessment questionnaire scored in four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness to Sounds.



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075229


Contacts
Contact: Teresa A Zwolan, Ph.D. 734-998-8119 zwolan@umich.edu
Contact: Craig Buchman, MD 314-362-7395 buchmanc@ent.wustl.edu

  Show 20 Study Locations
Sponsors and Collaborators
American Cochlear Implant Alliance
University of Michigan
University of Iowa
Johns Hopkins University
University of Miami
New York University School of Medicine
University of North Carolina
University of Southern California
Vanderbilt University
University of Washington
Washington University School of Medicine
Loyola University Chicago
University of Pennsylvania
University of Texas
Saint Luke's Health System
Massachusetts Eye and Ear
Medical College of Wisconsin
Medical University of South Carolina
Ohio State University
Rocky Mountain Ear Center
Investigators
Principal Investigator: Teresa A Zwolan, Ph.D University of Michigan & American Cochlear Implant Alliance

Responsible Party: Teresa A. Zwolan, PhD, Professor and Director, University of Michigan Cochlear Implant Program, American Cochlear Implant Alliance
ClinicalTrials.gov Identifier: NCT02075229     History of Changes
Other Study ID Numbers: CAG-00107N
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Teresa A. Zwolan, PhD, American Cochlear Implant Alliance:
Cochlear Implant
Post-lingual onset hearing loss
Profound hearing loss
Low Frequency hearing loss
Profound sensorineural hearing loss
High frequency hearing loss
CMS-eligible patients

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms