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

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Brief Title

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

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 Description

      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 Assessment will include

        1. Air conduction thresholds for each ear with insert earphones at 125, 250, 500, 750,
           1000, 1500, 2000, 3000,4000, 6000, and 8000 Hertz (Hz) Bone conduction thresholds for
           each ear at 125, 250, 500, 750, 1000, 1500, 2000, 4000Hz

        2. AzBio Sentences Test (Quiet) - One complete recorded list at 60 dB(A) presented to the
           sound field with the right ear aided, left ear aided, and bilateral aided while using
           amplification that has been verified as appropriate by the participant's managing
           audiologist.

      Baseline Measures Speech Perception Testing will include

        1. Consonant Nucleus Consonant (CNC) Monosyllabic Word Test (Quiet) - One complete recorded
           list presented at 60 dB(A) in the conditions of right ear aided, left ear aided,
           bilateral aided

        2. Telephone Testing will be performed using the ear to be implanted pre- implant. City of
           New York (CUNY) Sentences will be administered via live voice while the participant
           couples the ear to be implanted to his/her hearing aid using settings typical for phone
           use by that participant. If the participant is unable to use the phone, the test will
           still be administered with the telephone placed over the hearing aid microphone. No
           additional assistive listening devices (i.e. handset amplifier) or speaker phone
           settings will be used. Stimuli will be presented a single time only and feedback will
           not be provided. The examiner will use a conversational level and rate. The participant
           will repeat as much of the sentence as possible, guessing when necessary. Sentences will
           be scored for number of words repeated correctly and a percent of total words correct
           will be calculated.

      4. Self-Assessment Questionnaires: Patients will be instructed to complete three
      questionnaires as they pertain to how they presently hear in everyday listening situations.
      These questionnaires will also be administered 6 and 12 months post-activation. :

        -  Health Utility Index (HUI3)

        -  Short Form-36 with utility transforms

        -  Abbreviated Profile of Hearing Aid Benefit (APHAB) Form A

      Surgical Procedure: The recommended surgical procedure as outlined in the appropriate
      surgical manual for the device selected for implantation (provided by the device
      manufacturer) will be followed by the surgeon.

      Postoperative Procedures will be tailored to the needs of the patient, and will vary
      depending on the type of cochlear implant the patient receives.

      Activation should take place 2-4 weeks following surgery, or as soon as the surgeon has
      determined that the patient is able to participate in such an appointment and should include
      the following:

        -  Check incision site for signs of irritation or infection. Perform otoscopy. Refer
           patient to cochlear implant surgeon if there are concerns.

        -  Check adhesion of the speech processor magnet to ensure appropriateness of magnet
           strength. Increase or decrease magnet strength as needed.

        -  Perform listening check of speech processor microphone.

        -  Perform impedance testing (Telemetry)

        -  Recommended mapping parameters are provided to clinicians as defaults to begin with, but
           may be modified as needed based upon the recipient's response to sound.

      The scheduled follow up appointments for recipients will vary depending on the recipient's
      response to sound, clinic schedule, and distance traveled to the clinic by the recipient. In
      addition to device activation, it is recommended the audiologist try to meet with patients
      one, three, six, and twelve months post-activation. Formal testing will be performed six and
      twelve months post-activation per the study protocol.

      Recommended procedures to include in each mapping appointment have been provided to
      audiologists and include discussion of experience using the device, clarification of any
      questions regarding device use, listening check of speech processor microphone, impedance
      telemetry, psychophysical measures,loudness balancing,creation of new speech processor
      programs if levels have changed, and informal assessment of speech recognition.

      Patients should be referred to a speech-language pathologist for formal aural
      rehabilitation/training if, at the three month interval he/she demonstrates no open-set
      speech recognition of numbers, colors, or sentences; demonstrates difficulty adjusting to the
      sound quality of the cochlear implant; if there is a question regarding the presence of
      coexisting communication difficulties related to a change in cognitive status rather than
      hearing impairment; or if the recipient requests additional rehabilitation and training that
      the audiologist is not able to provide.

      Post-operative assessments will be performed at the six and twelve month test intervals and
      will include:

        1. Audiometric Testing to include aided cochlear implant sound field warble tone thresholds
           at 250, 500, 1000, 2000, 3000, and 4000 Hz (if a hearing aid is used, the hearing aid
           will be removed and the contralateral ear will be plugged with a foam plug)

        2. Speech Perception Testing will be performed with the CI alone and/or when using the CI +
           HA (if patient reports utilizing a hearing aid in the ipsilateral or contralateral ear
           at least 4 hours each day). Test will include the CNC Word Test (Quiet) - one complete
           list presented at 60 dB(A), and AzBio Sentences in Quiet - one complete list presented
           at 60 dB (A). Formal evaluation of performance using the hearing aid alone is not
           included in this study. Testing will include measures to evaluate performance when using
           the implant alone and when the patient utilizes a hearing aid plus the cochlear implant
           if the recipient reports that he/she utilizes a hearing aid (either in the ipsilateral
           or contralateral ear) a minimum of 4 hours each day. These measures include
           administration of CNC Words and AZ Bio Sentences in the bimodal condition of CI+HA at
           the 6 and 12 month post-activation intervals.

        3. Self-Assessment Questionnaires described above will be re-administered six and twelve
           months post-activation. Patients will be instructed to complete each questionnaire as it
           pertains to how they presently hear in everyday listening situations (e.g. when using
           the CI alone or when using the CI + HA if they use a hearing aid with the CI at least 4
           hours each day).

        4. Telephone testing as described above but using CI alone.

      Clinicians will provide participants with traditional rehabilitation, such as orientation to
      the device, description of strategies to improve hearing, use of assistive devices and
      accessories to improve performance, listening and communicating over the telephone, and
      counseling regarding speech recognition outcomes and expectations for performance.
      Audiologists will provide written materials regarding sources for independent rehabilitation
      and training.

      RISKS AND BENEFITS The pre-specified success criteria for this protocol will be determined
      based on sentence recognition performance in the best aided condition. Individual levels of
      margin of effectiveness will be assessed based on post-operative scores on CNC Words and AZ
      Bio Sentences. A statistically significant improvement in pre- to postoperative performance
      (six to twelve months postactivation) on scores in the best aided condition will be based on
      the binomial distribution of Thorton and Raffin, 1978 and the binomial distribution model
      provided by Spahr et al., 2011.

      Risks involved within this study include, but are not limited to, the risks associated with
      all cochlear implant surgery. It is anticipated that all study participants may permanently
      lose any residual hearing in the ear to be implanted. The potential benefits of cochlear
      implantation include improvement in the participant's ability to understand speech in quiet
      and in noise, with or without lip-reading, and to better detect speech and other
      environmental sounds.

      To monitor device safety (reported through adverse events), medical and audiological
      observations and procedures, such as adverse device effects and unanticipated adverse device
      effects, are to be reported to the center's Institutional Review Board (IRB) and also to the
      study coordinating center. Information on all device malfunctions and adverse events will be
      obtained from the investigational sites and maintained by event type. The surgeon and
      audiologist will complete a postoperative Adverse Event Questionnaire at each postoperative
      test interval if any adverse events have taken place. The questions in the adverse event form
      elicit information regarding any surgical, medical, and device-related complications for each
      study participant.

      Adverse device effects refer to any undesirable clinical or medical occurrence associated
      with use of the device or participation in the study. Adverse device effects will be reported
      if observed, even if they were acknowledged as risk factors in the Informed Consent Form.

      Unanticipated adverse device effects refer to any event not identified above that represents
      a serious adverse effect on health or safety or any life-threatening problem or death caused
      by, or associated with, a device if that effect, problem or death was not previously
      identified in nature, severity, or degree of incidence in the investigational plan or
      application, or any other unanticipated serious problem associated with a device that relates
      to the rights, safety, or welfare of subjects.

      Investigators are to inform their respective Institutional Review Boards (IRBs) and the study
      coordinator immediately if an unanticipated adverse device effect is suspected (no more than
      10 working days after the investigator learns of the effect). If the case is determined to be
      an unanticipated adverse device effect, the investigator will fill out an Unanticipated
      Adverse Device Effect Form. The study coordinator will report the results of an evaluation of
      the unanticipated adverse device effect to the FDA and all other reviewing IRBs and
      investigators within 10 working days after first receiving notice of the event.
    


Study Type

Observational


Primary Outcome

AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months

Secondary Outcome

 CNC Word Test at Baseline/Pre-Surgery, 6 and 12 months

Condition

Bilateral Sensorineural Hearing Loss

Intervention

Cochlear implant

Study Arms / Comparison Groups

 Group A
Description:  45 participants with AzBio baseline sentence scores between 41 - 50%

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

37

Start Date

February 2014

Completion Date

June 2021

Primary Completion Date

January 2021

Eligibility 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.
      

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Teresa A Zwolan, Ph.D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02075229

Organization ID

CAG-00107N


Responsible Party

Principal Investigator

Study Sponsor

American Cochlear Implant Alliance

Collaborators

 University of Michigan

Study Sponsor

Teresa A Zwolan, Ph.D, Principal Investigator, University of Michigan & American Cochlear Implant Alliance


Verification Date

May 2020