481 Form

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Medical Policy
Auditory Brainstem Implant Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 481 BCBSA Reference Number: 7.01.83 (For Plans internal use only) NCD/LCD: N/A Related Policies
• Cochlear Implant, #478 • Implantable Bone-Conduction and Bone-Anchored Hearing Aids, #479 • Semi-Implantable and Fully Implantable Middle Ear Hearing Aid, #480 Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Unilateral use of an auditory brainstem implant (using surface electrodes on the cochlear nuclei) may be MEDICALLY NECESSARY in individuals with neurofibromatosis type 2, who are 12 years of age or older, and who are rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.

An auditory brainstem implant is INVESTIGATIONAL for all other conditions including non- neurofibromatosis-type 2 indications.

Bilateral use of an auditory brainstem implant is INVESTIGATIONAL.

Penetrating electrode auditory brainstem implant (PABI) is INVESTIGATIONAL.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

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Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes:

Code Description 92640 Diagnostic analysis with programming of auditory brainstem implant, per hour HCPCS Codes HCPCS codes: Code Description S2235 Implantation of auditory brain stem implant The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT and HCPCS codes above if medical necessity criteria are met: ICD-10 Diagnosis Codes ICD-10 diagnosis codes: Code Description Q85.02 Neurofibromatosis, type 2

Description The auditory brainstem implant (ABI) is intended to restore some hearing in people with neurofibromatosis type 2 who are rendered deaf by bilateral removal of the characteristic neurofibromas involving the auditory nerve. The ABI consists of an externally worn speech processor that provides auditory information by electrical signal that is transferred to a receiver/stimulator implanted in the temporal bone. The receiver stimulator is, in turn, attached to an electrode array implanted on the surface of the cochlear nerve in the brainstem, 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. To place the electrode array on the surface of the cochlear nucleus, the surgeon must be able to visualize specific anatomic landmarks. Because large neurofibromas compress the brainstem and distort the underlying anatomy, it can be difficult or impossible for the surgeon to correctly place the electrode array. For this reason, patients with large, long-standing tumors may not benefit from the device.1,

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ABIs are also being studied to determine whether they can restore hearing for other non-neurofibromatosis causes of hearing impairment in adults and children, including absence of or trauma to the cochlea or auditory nerve. It is estimated that 1.7 per 100,000 children are affected by bilateral cochlea or cochlear nerve aplasia and 2.6 per 100,000 children are affected by bilateral cochlea or cochlear nerve hypoplasia.2,

Summary Description An auditory brainstem implant (ABI) is designed to restore some hearing in people with neurofibromatosis type 2 who are rendered deaf by bilateral removal of neurofibromas involving the auditory nerve. ABIs have also been studied to restore hearing for other non-neurofibromatosis indications.

Summary of Evidence For individuals who are deaf due to bilateral resection of neurofibromas of the auditory nerve who receive an auditory brainstem implant (ABI), the evidence includes a large, prospective case series and a technology assessment that included observational studies. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. The technology assessment found the highest quality evidence for improvement in hearing function, but evidence on other outcomes was lacking. The U.S. Food and Drug Administration approval of the Nucleus 24 device in 2000 was based on a prospective case series of 90 patients 12 years of age or older, of whom 60 had the implant for at least 3 months. From this group, 95% had a significant improvement in lip reading or improvement on sound-alone tests. While use of an ABI is associated with a very modest improvement in hearing, this level of improvement is considered significant for those patients who have no other treatment options. A systematic review of 16 studies found that ABI was associated with improved sound recognition and speech perception. Based on these results, ABIs are considered appropriate for the patient population age ≥12 years with neurofibromatosis type 2 and deafness following tumor removal. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. For individuals who are deaf due to nontumor etiologies who receive an ABI, the evidence includes case series and systematic reviews of case series. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. In general, ABIs have not demonstrated hearing benefits over cochlear implants for many conditions not related to neurofibromatosis type 2, and some older (now obsolete) ABI models have been associated with high rates of device failure and adverse events in this population. In addition, ABI studies have shown inferior outcomes in children with other disabilities. However, ABIs hold promise for select patients when the cochlea or cochlear nerve is absent. Evaluation is currently ongoing with the recently available Nucleus ABI541 to determine its efficacy and durability in children. Thus, further study is needed to define populations that would benefit from these devices. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 2/2026 Policy updates with literature review through December 24, 2025; no references added. Policy statements unchanged. 4/2025 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2024 Clarified coding language above table. 4/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 4/2023 Annual policy review. Minor editorial refinements to policy statements; intent unchanged. 3/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 4/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged.

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4/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 4/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2016 Annual policy review. New references added. 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes. Effective 10/2015. 5/2014 Annual policy review. New references added. 5/2013 Annual policy review. New references added. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
9/2011 Annual policy review. Changes to policy statements. 7/2010 Updated 7/10 based on the review of the BCBSA policy. Changes to policy statement.
5/2010 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 3/2010 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 5/2009 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 3/2009 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2009 Annual policy review. No changes to policy statements. 5/2008 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 5/2008 Annual policy review. No changes to policy statements. 3/2008 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 7/2007 Annual policy review. No changes to policy statements. 5/2007 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 3/2007 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 3/2007 Annual policy review. No changes to policy statements. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Food and Drug Administration. Nucleus 24 Auditory Brainstem Implant System. FDA Summary of Safety and Effectiveness. 2000; https://www.accessdata.fda.gov/cdrh_docs/pdf/P000015B.pdf; Accessed December 24, 2025.
2. Kaplan AB, Kozin ED, Puram SV, et al. Auditory brainstem implant candidacy in the United States in children 0-17 years old. Int J Pediatr Otorhinolaryngol. Mar 2015; 79(3): 310-315. PMID 25577282
3. Food and Drug Administration. Premarket Approval (PMA). Nucleus ABI541 Auditory Brainstem Implant. 2016. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000015S012. Accessed December 21, 2025.
4. Garcia A, Haleem A, Poe S, et al. Auditory Brainstem Implant Outcomes in Tumor and Nontumor Patients: A Systematic Review. Otolaryngol Head Neck Surg. Jun 2024; 170(6): 1648-1658. PMID 38329219

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5. Wang B, Yan M, Liu C, et al. Auditory brainstem implants for hearing rehabilitation in NF2- schwannomatosis: A systematic review and single-arm meta-analysis. NeuroRehabilitation. 2024; 54(2): 213-225. PMID 38427506
6. Ontario Health (Quality). Auditory brainstem implantation for adults with neurofibromatosis 2 or severe inner ear abnormalities: a health technology assessment. Ont Health Technol Assess Ser [Internet]. 2020 Mar;20(4): 185. https://www.hqontario.ca/evidence-to-improve-care/health- technology-assessment/reviews-and-recommendations/auditory-brainstem-implantation-for-adults- with-neurofibromatosis-2-or-severe-inner-ear-abnormalities; Accessed December 24, 2025.
7. Ebinger K, Otto S, Arcaroli J, et al. Multichannel auditory brainstem implant: US clinical trial results. J Laryngol Otol Suppl. 2000; (27): 50-3. PMID 11211440
8. Otto SR, Shannon RV, Wilkinson EP, et al. Audiologic outcomes with the penetrating electrode auditory brainstem implant. Otol Neurotol. Dec 2008; 29(8): 1147-54. PMID 18931643
9. Daoudi H, Torres R, Mosnier I, et al. Long-term analysis of ABI auditory performance in patients with neurofibromatosis type 2-related schwannomatosis. Acta Neurochir (Wien). Oct 02 2024; 166(1): 390. PMID 39356313
10. Merkus P, Di Lella F, Di Trapani G, et al. Indications and contraindications of auditory brainstem implants: systematic review and illustrative cases. Eur Arch Otorhinolaryngol. Jan 2014; 271(1): 3-13. PMID 23404468
11. Medina M, Di Lella F, Di Trapani G, et al. Cochlear implantation versus auditory brainstem implantation in bilateral total deafness after head trauma: personal experience and review of the literature. Otol Neurotol. Feb 2014; 35(2): 260-70. PMID 24448286
12. Sennaroglu L, Lenarz T, Roland JT, et al. Current status of pediatric auditory brainstem implantation in inner ear malformations; consensus statement of the Third International Pediatric ABI Meeting. Cochlear Implants Int. Jul 2024; 25(4): 316-333. PMID 39607757
13. Noij KS, Kozin ED, Sethi R, et al. Systematic Review of Nontumor Pediatric Auditory Brainstem Implant Outcomes. Otolaryngol Head Neck Surg. Nov 2015; 153(5): 739-50. PMID 26227469
14. Colletti L, Wilkinson EP, Colletti V. Auditory brainstem implantation after unsuccessful cochlear implantation of children with clinical diagnosis of cochlear nerve deficiency. Ann Otol Rhinol Laryngol. Oct 2013; 122(10): 605-12. PMID 24294682
15. Sennaroğlu L, Sennaroğlu G, Yücel E, et al. Long-term Results of ABI in Children With Severe Inner Ear Malformations. Otol Neurotol. Aug 2016; 37(7): 865-72. PMID 27273392
16. 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. Sep 2009; 30(6): 708-15. PMID 19704357
17. Baş B, Gökay NY, Aydoğan Z, et al. Do auditory brainstem implants favor the development of sensory integration and cognitive functions?. Brain Behav. Aug 2024; 14(8): e3637. PMID 39099332
18. Colletti V, Carner M, Miorelli V, et al. Auditory brainstem implant (ABI): new frontiers in adults and children. Otolaryngol Head Neck Surg. Jul 2005; 133(1): 126-38. PMID 16025066
19. Colletti V. Auditory outcomes in tumor vs. nontumor patients fitted with auditory brainstem implants. Adv Otorhinolaryngol. 2006; 64: 167-185. PMID 16891842
20. Colletti L. Beneficial auditory and cognitive effects of auditory brainstem implantation in children. Acta Otolaryngol. Sep 2007; 127(9): 943-6. PMID 17712673
21. Colletti V, Shannon RV, Carner M, et al. Complications in auditory brainstem implant surgery in adults and children. Otol Neurotol. Jun 2010; 31(4): 558-64. PMID 20393378
22. National Institute Health and Care Excellence (NICE). Auditory brain stem implants [IPG108]. 2005. https://www.nice.org.uk/guidance/ipg108. Accessed December 20, 2025.