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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population

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.


Detailed Summary:

Informed Consent will be obtained prior to enrollment in the study, and will include an interview to discuss study expectations, potential risks and benefits and the study evaluation schedule. The Informed Consent Form may be taken home and reviewed by the candidate and the candidate will be given the opportunity to ask questions about it and/or the study prior to signing the form. The candidate will then be given a copy of the signed Informed Consent Form.

The Informed Consent Forms will include a detailed list of procedures included in the pre-operative evaluation process. The Informed Consent document will be reviewed and signed by the relevant parties prior to any study-related evaluation taking place. Testing completed as part of normal clinical practice, such as the audiogram is acceptable prior to signing the consent form.

Information regarding each participant's hearing history will be collected and may be obtained from the participant directly or from their medical record.

The Preoperative evaluation includes:

  1. Assessment of the candidate's suitability for the study
  2. Establishment of baseline data if the candidate proves to be appropriate for study inclusion.

During preoperative testing, the patient will utilize hearing aids that have been verified as appropriate by the participant's managing audiologist. Clinicians will base the appropriateness of the hearing aid fitting on the recommendations of the American Academy of Audiology Task Force (2006). This includes real ear measures to verify accuracy of the hearing aid settings.

Candidacy Assessmen
Sponsor: American Cochlear Implant Alliance

Current Primary Outcome: 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.


Original Primary Outcome: Hearing in Noise Test (HINT) 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.


Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • CNS 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.
  • AZ Bio Sentences 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. ]
    These sentences differ from HINT sentences as they are presented by four different talkers (2 female and 2 male) and have more difficult linguistic content. Subjects are given a percent correct score based on the percentage of words correctly repeated back. The test is administered prior to and after receiving a cochlear implant to determine if their ability to recognize words in sentences has improved.
  • 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.
  • 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.
  • Resource Use and Expenditure Questionnaire [ Time Frame: Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant. ]
    This instrument focuses on costs associated with hearing loss. The questionnaire will be administered prior to and after the subject receives a cochlear implant and will aid in providing information relative to the cost of effectiveness of cochlear implants.
  • 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.


Information By: American Cochlear Implant Alliance

Dates:
Date Received: February 21, 2014
Date Started: February 2014
Date Completion: June 2019
Last Updated: April 18, 2017
Last Verified: April 2017