Cochlear Implantation (Effective April 4, 2005)

50.3 - Cochlear Implantation (Effective April 4, 2005) (Rev. 11875; Issued:02-23-23; Effective: 09-26-22; Implementation: 03-24-23) A. General 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. B. Nationally Covered Indications Effective for services performed on or after September 26, 2022, cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate- to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence recognition. Patients must meet all of the following criteria. • Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids; • Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation; • Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system; • No contraindications to surgery; and • The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling. C. Nationally Non-Covered Indications Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation listed in Section B are deemed not eligible for Medicare coverage except as described in Section D below. D. Other CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials. (This NCD last reviewed September 2022)