Auditory Brain Stem Implant
© Blue Cross and Blue Shield of Montana
Current Effective Date:
June 01, 2013
Original Effective Date:
December 18, 2009
June 01, 2013
June 13, 2012; April 28, 2013
The auditory brainstem implant (ABI) is a device designed to restore some hearing in people with neurofibromatosis-type II (NF2) who are rendered deaf by bilateral removal of the characteristic neurofibromas involving the auditory nerve. The device consists of an externally worn speech processor that provides auditory information to an electrical signal that is transferred to a receiver/stimulator that is implanted in the temporal bone. The receiver/stimulator is, in turn, attached to an electrode array that is implanted on the surface of the cochlear nerve in the brain stem, thus bypassing the inner ear and auditory nerve. The electrode stimulates multiple sites on the cochlear nucleus, which is then processed normally by the brain.
One device has received approval by the U.S. Food and Drug Administration (FDA) for auditory brainstem implantation, the Nucleus® 24 Auditory Brainstem Implant System (Cochlear Corporation). The speech processor and receiver are similar to the devices used in cochlear implants; the electrode array placed on the brainstem is the novel component of the device. The device is indicated for individuals 12 years of age or older, who have been diagnosed with NF2.
BCBSMT may consider unilateral auditory brainstem implant (ABI), (using surface electrodes on the cochlear nuclei), medically necessary when ALL of the following criteria are met:
- Diagnosis of neurofibromatosis-type II (NF2); and
- The individual is 12 years of age or older; and
- The individual has been rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
BCBSMT considers an auditory brainstem implant experimental, investigational and unproven for all other indications, including non-NF2 indications.
Bilateral auditory brainstem implant is considered experimental, investigational and unproven.
Penetrating electrode auditory brainstem implant (PABI) is considered experimental, investigational and unproven.
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- Nucleus ® 24 Auditory Brainstem Implant System. FDA Summary of Safety and Effectiveness. Available online at: http://www.accessdata.fda.gov Last accessed March 2012.
- Ebinger K, Otto S, Arcaroli J et al. Multichannel auditory brainstem implant: US clinical trial results. J Laryngol Otol Suppl 2000; (27):50-3.
- Sanna M, Di Lella F, Guida M et al. Auditory brainstem implants in NF2 patients: results and review of the literature. Otol Neurotol 2012; 33(2):154-64.
- Colletti V, Fiorino FG, Carner M et al. Auditory brainstem implant as a salvage treatment after unsuccessful cochlear implantation. Otol Neurotol 2004; 25(4):485-96; discussion 96.
- Colletti V, Carner M, Miorelli V et al. Auditory brainstem implant (ABI): new frontiers in adults and children. Otolaryngol Head Neck Surg 2005; 133(1):126-38.
- Colletti V. Auditory outcomes in tumor vs. nontumor patients fitted with auditory brainstem implants. Adv Otorhinolaryngol 2006; 64:167-85.
- Colletti L. Beneficial auditory and cognitive effects of auditory brainstem implantation in children. Acta Otolaryngol 2007; 127(9):943-6.
- Colletti V, Shannon RV, Carner M et al. Complications in auditory brainstem implant surgery in adults and children. Otol Neurotol 2010; 31(4):558-64.
- Sennaroglu L, Ziyal I, Atas A et al. Preliminary results of auditory brainstem implantation in prelingually deaf children with inner ear malformations including severe stenosis of the cochlear aperture and aplasia of the cochlear nerve. Otol Neurotol 2009; 30(6):708-15.
- Otto SR, Shannon RV, Wilkinson EP et al. Audiologic outcomes with the penetrating electrode auditory brainstem implant. Otol Neurotol 2008; 29(8):1147-54.
- Schwartz MS, Otto SR, Shannon RV et al. Auditory brainstem implants. Neurotherapeutics 2008; 5(1):128-36.
- National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 108. Auditory brain stem implants. 2005. Available online at: http://guidance.nice.org.uk. Last accessed March 2012.
- Medicare Policy Benefit Manual. Chapter 16 - General Exclusions from Coverage. Available online at: http://www.cms.gov . Last accessed March 2011.
- Auditory Brainstem Implant. Chicago, Illinois: Blue Cross Blue Shield Association Medical policy Reference Manual (2012 April) Surgery 7.01.83.
||Policy updated with literature review; Rationale section reorganized; reference 3 and 13 added; no change in policy statement |
||Policy language and formatting revised. No change to policy statement.|