Cochlear Implants for Sensorineural Hearing Loss

The Centers for Medicare and Medicaid Services (CMS) has convened this meeting for the panel to review the evidence on health outcomes attributable to unilateral and bilateral cochlear implantation for its beneficiaries.

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code sound. Cochlear implant devices are available in single-channel and multi-channel models. The purpose of implanting the device is to provide awareness and identification of sounds and to facilitate communication for persons who are moderately to profoundly hearing impaired.

In 2005, CMS published National Coverage Determination (NCD) for Cochlear Implantation (50.3). This NCD establishes Medicare's criteria for coverage of cochlear implantation. Among other criteria, the patient must derive limited benefit from current means of sound amplification. Limited benefit is defined by test scores of less than or equal to 40% correct in the best-aided listening condition on tape recorded tests of open set sentence recognition.

For those patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60% (and who meet Medicare's other coverage criteria), NCD 50.3 states that cochlear implantation may be covered, but only when the provider is participating in, and patients are enrolled in, either an FDA-approved category B investigational device exemption clinical trial as defined at 42 CFR 405.201, a trial under the Centers for Medicare & Medicaid (CMS) Clinical Trial Policy as defined at section 310.1 of the National Coverage Determinations Manual, or a prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards. Since the 2005 NCD was published, we are unaware of any new clinical trials that adequately address the impact of cochlear implantation in patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60%.

March 5, 2011

March 15, 2011

May 9, 2011

May 9, 2011

May 16, 2011

July 12, 2011

• Webcast of meeting
• Registration
• Webinar registration
• Information about visiting CMS

Registrations have closed.

7:30 – 8:00 AM

8:00 – 8:15 AM

8:15 - 8:35 AM

8:35 – 8:55 AM

8:55 – 9:15 AM

9:15 – 10:00 AM

10:00 – 10:15 AM

10:15 – 11:00 AM

11:00 – 11:15 AM

Public Attendees who wish to address the panel will be given that opportunity

11:15 – 12:00 PM

12:00 – 1:00 PM

1:00 – 2:00 PM

2:00 – 3:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:00 – 4:00 PM

4:00 – 4:30 PM

The questions below all refer to the use of cochlear implant(s) in adults with bilateral sensorineural, moderate to profound hearing loss who demonstrate limited benefit from amplification. Definitions of terms included in these questions are:

• Limited benefit from amplification is defined by the correct test scores noted in the questions below, obtained with the best aided listening condition on tape or otherwise recorded tests of open-set sentence recognition.
• Health outcomes include symptom status, functional abilities and health related quality of life. In your discussions please note if your conclusions apply only to specific outcomes or more broadly.

For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence.

1. How confident are you that there is adequate evidence to determine whether or not a unilateral (i.e. first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of:

   1. >40% and ≤50%
   2. >50% and ≤60%

Discussion for Question 1:

Is there an absolute or relative change in test scores that indicates a clinically meaningful difference in health outcomes for this population?

2. If the result of Question 1 is at least intermediate (mean vote ≥ 2.5) for either range of correct open set sentence recognition scores noted above, how confident are you that a unilateral (i.e. first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of :

   1. >40% and ≤50%
   2. >50% and ≤60%

Discussion for Question 2:

Are there any specific factors, other than test scores (e.g.anatomy, duration of hearing loss, characteristics of facilities/care providers, etc.), that can aid in the identification of those individuals most likely to attain improved health outcomes?

If the answer to question 3b is at least intermediate (mean vote ≥ 2.5), continue on to questions 4-9.

4. How confident are you that there is adequate evidence to determine whether or not a sequential bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below ?

   1. ≤ 40%
   2. > 40 % and ≤ 50%,
   3. > 50% and ≤ 60%

5. If the answer to question 4 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a sequential bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

   1. ≤ 40%
   2. > 40 % and ≤ 50%
   3. > 50% and ≤ 60%

6. How confident are you that there is adequate evidence to determine whether or not a simultaneous bilateral cochlear implantation as compared to a unilateralcochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

   1. ≤ 40%
   2. > 40 % and ≤ 50%
   3. > 50% and ≤ 60%

7. If the answer to question 6 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a simultaneous bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss with test scores in the ranges below ?

   1. ≤ 40%
   2. > 40 % and ≤ 50%
   3. > 50% and ≤ 60%

8. How confident are you that there is adequate evidence to determine whether or not a simultaneous bilateral cochlear implantation as compared to a sequential cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

   1. ≤ 40%
   2. > 40 % and ≤ 50%
   3. > 50% and ≤ 60%

9. If the answer to question 8 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a simultaneous bilateral cochlear implantation as compared to a sequential cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

   1. ≤ 40%
   2. > 40 % and ≤ 50%
   3. > 50% and ≤ 60%

10. What significant evidence gaps exist regarding the clinical criteria of individuals who should receive cochlear implants, either unilateral or bilateral?

11. How confident are you that these conclusions are generalizable to:

    1. The Medicare patient population?
    2. Community based settings?

Download scoresheet [PDF, 97KB]