Cochlear Implant for Treatment of Sensorineural Deafness
DESCRIPTION
A cochlear implant provides direct electrical stimulation to the auditory nerve, bypassing the usual transducer cells that are absent or nonfunctional in deaf cochlea. The basic components of a cochlear implant include both external and internal components. The external components include a microphone, an external sound processor, and an external transmitter. The internal components are implanted surgically. An internal receiver is implanted within the temporal bone and an electrode array extends from the receiver into the cochlea. Sounds are picked up by the microphone and carried to the external sound processor. The processor transforms sound into coded signals that are then transmitted transcutaneously to the implanted internal receiver. The receiver converts the incoming signals to electrical impulses that are conveyed to the electrode array, resulting in stimulation of the auditory nerve.
POLICY
Unilateral or bilateral cochlear implantation for the treatment of sensorineural hearing loss is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Unilateral or bilateral cochlear implantation for the treatment of sensorineural hearing loss is considered medically appropriate if ALL of the following criteria are met:
The Individual is 12 months of age and older
Has bilateral severe to profound prelingual or postlingual sensorineural hearing loss (e.g., a hearing threshold of 70 decibels or greater)
Is free from otitis media or other active, unresolved ear disorders
Has accessible cochlear lumen structurally suited to implantation
Deafness is not due to lesions in the auditory nerve and acoustic areas of the central nervous system
Has cognitive ability to use auditory clues and a willingness to undergo a program of rehabilitation
Has radiographic evidence of cochlear development
ADDITIONAL INFORMATION
No single processor for bilateral cochlear implantation has been approved by the FDA for use in the United States. In addition, single processors do not provide binaural benefit and may impair sound localization and increase the signal to noise ratio received by the cochlear implant.
A post-cochlear implant rehabilitation program is necessary to achieve benefit from the cochlear implant. The rehabilitation program consists of 6 to 10 sessions that last approximately 2.5 hours each. The rehabilitation program includes development of skills in understanding running speech, recognition of consonants and vowels, and tests of speech perception ability.
NOTE: The position of BlueCross BlueShield of Tennessee is that the temporal bone conduction implant (e.g., Baha®) is a hearing aid. The temporal bone conduction hearing aid transmits sound waves through the temporal bone to the ossicles of the middle ear. The device has three connected components including the sound processor, the abutment and the implant. The sound vibrations are picked up by the sound processor and transferred to the abutment. The implant receives the sound vibrations from the abutment and through bone conduction transmits them into the cochlea. This device requires a functioning cochlear for the reception of the sound vibrations.
The FDA has approved several pre market notifications on the Baha® device as a bone conduction type hearing aid. The National Institute on Deafness and other Communication Disorders (NIDCD) classifies the Baha® as a bone anchored hearing aid. The NIDCD also defines a hearing aid as an “electronic device that brings amplified sound to the ear. A hearing aid usually consists of a microphone, amplifier, and receiver.”
It is important to note that member benefits for hearing-related services and equipment can vary according to member eligibility on the date of service, benefit plan exclusions, limitations, other requirements, and criteria.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2008). Cochlear implant (7.01.05). Retrieved May 20, 2009 from BlueWeb.
Center for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices. (2003). Pneumococcal vaccination for cochlear implant candidates and recipients: Updated recommendations of the Advisory Committee on immunization practices. Morbidity and Mortality Weekly Report, 52 (31), 739 - 740.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Cochlear implantation (NCD 50.3, p. 2-35). The Ingenix Complete Guide to Medicare Coverage Issues.
Connell, S. S., & Balkany, T. J. (2006). Cochlear implants. Clinics in Geriatric Medicine, 22 (3), 677 - 686. (Level 5 Evidence)
Francis, H. W., & Niparko, J. K. (2003). Cochlear Implantation update. The Pediatric Clinics of North America, 50 (2), 341 - 61. (Level 5 Evidence)
Hayes. Medical Technology Directory. (2007 December). Cochlear Implantation. Retrieved June 11, 2009 from www.Hayesinc.com/subscribers. (83 articles and/ or guidelines reviewed)
Koch, D. B., Staller, S., Jaax, K., & Martin, E. (2005). Bioengineering solutions for hearing loss and related disorders. Otolaryngologic Clinics of North America, 38 (2), 255 - 272. (Level 5 Evidence)
Kuhn-Inacker, H., Shehata-Dieler, W., Muller, J., & Helms, L. (2004). Bilateral cochlear implants: A way to optimize auditory perception abilities in deaf children. International Journal of Pediatric Otorhinolaryngology, 68 (10), 1257 - 1266. (Level 5 Evidence)
Litovsky, R. Y., Johnstone, P. M., Godar, S., Agrawal, S., Parkinson, A, Peters, R., et al. (2006). Bilateral cochlear implants in children: Localization acuity measured with minimum audible angle. Ear and Hearing, 27 (1), 43 - 59. (Level 4 Evidence)
Litovsky, R. Y., Parkinson, A., Arcaroli, J., Peters, R., Lake, J., Johnson, P., et al. (2004). Bilateral cochlear implants in adults and children. Archives of Otolaryngology - Head and Neck Surgery, 130 (5), 648 - 655. (Level 4 Evidence)
Miyamoto, R. T., & Bichey, B. G. (2003). Cochlear implantation for tinnitus suppression. Otolarygologic Clinics of North America, 36 (2), 345 - 352. (Level 5 Evidence)
National Institute on Deafness and other Communication Disorders. (2007, April). Hearing Aids. Retrieved October 6, 2009 from http://www.nidcd.nih.gov/health/hearing/hearingaid.asp.
National Institute on Deafness and other Communication Disorders. (2008, April). Glossary. Retrieved October 6, 2009 from http://www.nidcd.nih.gov/health/glossary/glossary.asp.
Roland, J. T., Huang, T. C., & Cohen, N. L. (2006). Revision cochlear implantation. Otolaryngologic Clinics of North America, 39 (4), 833 - 839. (Level 5 Evidence)
Sharma, A., Dorman, M. F., & Spahr, A. J. (2002). A sensitive period for the development of the central auditory system in children with cochlear implants: Implications for age of implantation. Ear and Hearing, 23 (6), 532 - 539. (Level 4 Evidence)
Summerfield, A. Q., Marshall, D. H., Barton, G. R., & Bloor, K. E. (2002). A cost-utility scenario analysis of bilateral cochlear implantation. Archives of Otolaryngology - Head and Neck Surgery, 128 (11), 1255 - 1262. (Level 4 Evidence)
U. S. Food and Drug Administration. (2000, October). Center for Devices and Radiological Health. Nucleus 24 Auditory Brainstem Implant System. Retrieved June 11, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000015 .
U. S. Food and Drug Administration. (2001, August). Center for Devices and Radiological Health. MED-EL COMBI+ Cochlear Implant System. Retrieved June 11, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P000025b.pdf.
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. Devices @ FDA. Retrieved May 11, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/.
ORIGINAL EFFECTIVE DATE: 4/1985
MOST RECENT REVIEW DATE: 8/13/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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