Latest Review Date: March 2024

Category: Surgery                                                                  

POLICY:

Unilateral or bilateral cochlear implantation of a U.S. Food and Drug Administration (FDA)-approved cochlear implant device may be considered medically necessary in individuals age 9 months and older with bilateral severe to profound pre- or post-lingual (sensorineural) hearing loss defined as a hearing threshold of pure-tone average of 70 dB (decibels) hearing loss or greater at 500 Hz (hertz), 1,000 Hz, and 2,000 Hz, and have shown limited or no benefit from hearing aids.

Cochlear implantation as a treatment for individuals with unilateral hearing loss with or without tinnitus is considered investigational.

Cochlear implantation with an FDA approved hybrid cochlear implant/hearing aid device (e.g. Nucleus^® Hybrid^™ L24 Cochlear Implant System) that includes the hearing aid integrated into the external sound processor of the cochlear implant may be considered medically necessary for individuals ages 18 years and older who meet all the following criteria:

• Bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency hearing sensitivity; AND
• Receive limited benefit from appropriately fit bilateral hearing aids; AND

• Have the following hearing thresholds:

  • Low frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation; AND
  • Severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB hearing level) in the ear to be implanted; AND
  • Moderately severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥60 dB hearing level) in the contralateral ear; AND
  • Aided- consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct.

Replacement or upgrade of existing properly functioning durable medical equipment (including prosthetics), even if the warranty has expired is a contract exclusion.*

Replacement for lost sound processors are non-covered. Individuals should contact the manufacturer for replacement under warranty or the manufacturer’s replacement policy.

*Always check benefits for self-funded groups as it relates to contract exclusions.

POLICY GUIDELINES:

• Bilateral cochlear implantation should be considered only when it has been determined that the alternative of unilateral cochlear implantation plus hearing aid in the contralateral ear will not result in a binaural benefit (i.e., in those individuals with hearing loss of a magnitude where a hearing aid will not produce the required amplification).
• In certain situations, implantation may be considered before 12 months of age. One scenario is after meningitis when cochlear ossification may preclude implantation. Another is in cases with a strong family history, because establishing a precise diagnosis is less uncertain.
• Hearing loss is rated based on the threshold of hearing. Severe hearing loss is defined as a bilateral hearing threshold of 70 to 90 dB, and profound hearing loss is defined as a bilateral hearing threshold of 90 dB and above.
• In adults, limited benefit from hearing aids is defined as scores of 50% correct or less in the ear to be implanted on tape-recorded sets of open-set sentence recognition. In children, limited benefit is defined as failure to develop basic auditory skills, and in older children, 30% or less correct on open-set tests.
• 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.
• Contraindications to cochlear implantation may include deafness due to lesions of the eighth cranial (acoustic) nerve, central auditory pathway, or brainstem; active or chronic infections of the external or middle ear; and mastoid cavity or tympanic membrane perforation. Cochlear ossification may prevent electrode insertion, and the absence of cochlear development as demonstrated on computed tomography scans remains an absolute contraindication.

DESCRIPTION OF PROCEDURE OR SERVICE:

A cochlear implant is a device for individuals with severe-to-profound hearing loss who only receive limited benefit from amplification with hearing aids. 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 structure of a cochlear implant includes 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 and include an internal receiver implanted within the temporal bone and an electrode array that extends from the receiver into the cochlea through a surgically created opening in the round window of the middle ear.

Sounds that are picked up by the microphone are carried to the external sound processor, which 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 then conveyed to the electrode array, ultimately resulting in stimulation of the auditory nerve.

KEY POINTS:

The most recent literature search was performed through January 2, 2024.

Summary of Evidence

For individuals who have bilateral sensorineural hearing loss who receive the cochlear implant(s), the evidence includes randomized controlled trials (RCTs) and multiple systematic reviews and technology assessments. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. The available studies have reported improvements in speech reception and quality of life measures. Although the available RCTs and other studies measured heterogeneous outcomes and included varying patient populations, the findings are consistent across multiple studies and settings. In addition to consistent improvement in speech reception (especially in noise), studies showed improvements in sound localization with bilateral devices. Studies have also suggested that earlier implantation may be preferred. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have unilateral sensorineural hearing loss who receive the cochlear implant(s), the evidence includes a feasibility study, prospective and retrospective studies reporting within-subjects comparisons, and systematic reviews of observational studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. Given the natural history of hearing loss, pre- and post-implantation comparisons may be appropriate for objectively measured outcomes. However, the available evidence for the use of cochlear implants in improving outcomes for patients with unilateral hearing loss, with or without tinnitus, is limited by small sample sizes and heterogeneity in evaluation protocols and outcome measurements. A small feasibility study in adults with single-sided deafness or asymmetric hearing loss demonstrated improvements in sound perception, sound localization, and subjective measures of quality of life compared to baseline conditions. Prospective studies assessing outcomes compared to best-aided hearing controls beyond 6 months are lacking. Ongoing post-marketing studies in adults and children may further elucidate outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a high-frequency sensorineural hearing loss with preserved low-frequency hearing who receive a hybrid cochlear implant that includes a hearing aid integrated into the external sound processor of the cochlear implant, the evidence includes prospective and retrospective studies using single-arm, within-subject comparison pre- and post-intervention and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. The available evidence has suggested that a hybrid cochlear implant system is associated with improvements in hearing of speech in quiet and noise. The available evidence has also suggested that a hybrid cochlear implant improves speech recognition better than a hearing aid alone. Some studies have suggested that a shorter cochlear implant insertion depth may be associated with preserved residual low-frequency hearing, although there is uncertainty about the potential need for reoperation after hybrid cochlear implantation if there is a loss of residual hearing. Studies reporting on long-term outcomes and results of re-implantation are lacking.

Practice Guidelines and Position Statements

American Academy of Otolaryngology-Head and Neck Surgery

In 2020, the American Academy of Otolaryngology - Head and Neck Surgery Foundation released an updated position statement on cochlear implants. The Foundation “...considers unilateral and bilateral cochlear implantation as appropriate treatment for adults and children over 9 months of age with moderate to profound hearing loss who have failed atrial with appropriately fit hearing aids.”

Agency for Health Care Research and Quality

In April 2011, a technology assessment was completed by the Tufts Evidence-based Practice Center for the AHRQ on the effectiveness of cochlear implants in adults. The assessment conclusions are noted above.

National Institute for Health and Care Excellence

In 2019, the National Institute for Health and Care Excellence (NICE) released a technology appraisal guidance on cochlear implants for children and adults with severe-to-profound deafness

The guidance included the following updated recommendations:

1.1       “Unilateral cochlear implantation is recommended as an option for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids, as defined in 1.5.

1.2       Simultaneous bilateral cochlear implantation is recommended as an option for the following groups of people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids.

a.         Children

b.         Adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness.

1.3       Sequential bilateral cochlear implantation is not recommended as an option for people with severe to profound deafness.

1.4       Cochlear implantation should be considered for children and adults only after an assessment by a multidisciplinary team. As part of the assessment, children and adults should also have had a valid trial of an acoustic hearing aid for at least 3 months (unless contraindicated or inappropriate).”

1.5       For the purposes of this guidance, severe to profound deafness is defined as hearing only sounds that are louder than 80 dB HL [hearing level] at 2 or more frequencies bilaterally (500 Hz, 1 kHz, 2 kHz, 3 kHz, 4 kHz) without acoustic hearing aids. Adequate benefit from acoustic hearing aids is defined for this guidance as:

a.         for adults, a phoneme score of 50% or greater on the Arthur Boothroyd word test presented at 70 dBA

b.         for children speech, language and listening skills appropriate to age, developmental stage, and cognitive ability.

1.7       Cochlear implantation should be considered for … adults only after an assessment by a multidisciplinary team. As part of the assessment … [implant candidates] should also have had a valid trial of an acoustic hearing aid for at least 3 months (unless contraindicated or inappropriate).”

National Institutes of Health

Cochlear implants are recognized as an effective treatment of sensorineural deafness, as noted in a 1995 National Institutes of Health Consensus Development conference, which offered the following conclusions:

• Cochlear implantation has a profound impact on hearing and speech reception in postlingually deafened adults with positive impacts on psychological and social functioning.
• Prelingually deafened adults may also benefit, although to a lesser extent than postlingually deafened adults may. These individuals achieve minimal improvement in speech recognition skills. However, other basic benefits, such as improved sound awareness, may meet safety needs.
• Training and educational intervention are fundamental for optimal post implant benefit.

The conference offered the following conclusions regarding cochlear implantation in children:

• Cochlear implantation has variable results in children. Benefits are not realized immediately but rather are manifested over time, with some children continuing to show improvement over several years.

Cochlear implants in children under 2-years-old are complicated by the inability to perform detailed assessment of hearing and functional communication. However, a younger age of implantation may limit the negative consequences of auditory deprivation and may allow more efficient acquisition of speech and language. Some children with post-meningitis hearing loss under the age of 2 years have received an implant due to the risk of new bone formation associated with meningitis, which may preclude a cochlear implant at a later date.

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY WORDS:

Prelingual deafness, post lingual deafness, profound deafness, severe profound deafness, bilateral cochlear implants, bilateral implantation, Nucleus Hybrid L24 Cochlear Implant System, Med El^® EAS Hearing Implant System

APPROVED BY GOVERNING BODIES:

Several cochlear implants are commercially available in the U.S. and are manufactured by Cochlear Corporation, Advanced Bionics, and the MED EL Corporation. Over the years, the U.S. Food and Drug Administration (FDA), focusing on improved electrode design and speech-processing capabilities, have approved subsequent generations of the various components of the devices. Furthermore, smaller devices and the accumulating experience in children have resulted in broadening of the selection criteria to include children as young as 12 months. The labeled indications from the FDA for currently marketed implant devices are summarized in the table below.

Table 1. Cochlear Implant Systems Approved by the U.S. Food and Drug Administration

Variables	Manufacturer and Currently Marketed Cochlear Implants
Device	Advanced Bionics® HiResolution® Bionic Ear System (HiRes 90K)	Cochlear® Nucleus 22 and 24	Med El® Maestro Combi 40+	Neuro Cochlear Implant System (Oticon Medical)
PMA	P960058	P840024, P970051	P000025	P200021
Indications
Adults ≥18 y	· Postlingual onset of severe-to-profound bilateral SNHL (≥70 dB) · Limited benefit from appropriately fitted hearing aids, defined as scoring ≤50% on a test of open-set HINT sentence recognition	· Pre-, peri-, or postlingual onset of bilateral SNHL, usually characterized by: Moderate-to-profound HL in low frequencies; and Profound (≥90 dB) HL in mid-to-high speech frequencies Severe to profound unilateral SNHL(SSD or AHL) PTA at500 Hz,1000 Hz,2000 Hz, and 4000Hz of >80 dB HL Normal or near normal hearing in the contralateral ear defined as PTA at500 Hz,1000 Hz,2000 Hz, and 4000Hz of ≤30 dB HL Limited benefit from an appropriately fitted unilateral hearing device	· Severe-to-profound bilateral SNHL (≥70 dB) · ≤40% correct HINT sentences with best-sided listening condition	Severe-to-profound bilateral SNHL(≥70 dB at 500,1000, and 2000Hz) Limited benefit from appropriately fit hearing aids, defined as scoring ≤50%correct HINT sentences in quiet or noise with best-sided listening condition
Children	12 mo to 17 y of age · Profound bilateral SNHL (>90 dB) · Use of appropriately fitted hearing aids for at least 6 mo in children 2-17 y or at least 3 mo in children 12-23 mo Lack of benefit in children <4 y defined as a failure to reach developmentally appropriate auditory milestones (e.g., spontaneous response to name in quiet or to environmental sounds) measured using IT-MAIS or MAIS or <20% correct on a simple open-set word recognition test (MLNT) administered using monitored live voice (70 dB SPL) · Lack of hearing aid benefit in children >4 y defined as scoring <12% on a difficult open-set word recognition test (PBK test) or <30% on an open-set sentence test (HINT for Children) administered using recorded materials in the sound field (70 dB SPL)	25 mo to 17 y 11 mo Severe-to-profound bilateral SNHL MLNT scores ≤30% in best-aided condition in children 25 mo to 4 y 11 mo LNT scores ≤30% in best-aided condition in children 5 y to 17 y and 11 mo 12-24 mo Profound SNHL bilaterally Limited benefit from appropriate binaural hearing aids   9 to 24 mo of age Profound SNHL bilaterally Limited benefit from appropriate binaural hearing aids 5 y to 18 y of age Severe to profound unilateral SNHL(SSD or AHL)PTA at 500 Hz,1000 Hz,2000 Hz, and 4000Hz of >80 dB HL Normal or near normal hearing in the contralateral ear defined as PTA at500 Hz,1000 Hz,2000 Hz, and 4000Hz of ≤30 dB HL Limited benefit from an appropriately fitted unilateral hearing device	12 mo to 18 y Profound sensorineural HL (≥90 dB) In younger children, little or no benefit is defined by lack of progress in the development of simple auditory skills with hearing aids over 3 to 6 mo In older children, lack of aided benefit is defined as <20% correct on the MLNT or LNT, depending on child’s cognitive ability and linguistic skills A 3- to 6-mo trial with hearing aids is required if not previously experienced   5 y to 18 y of age SSD (≥90 dB) or AHL (Δ15 dB PTA) Insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on developmentally appropriate monosyllabic word lists when tested in the ear to be implanted Patients must have at least 1-month experience wearing a CROS hearing aid or other relevant device and not show any subjective benefit.	Not applicable.

AHL: asymmetric hearing loss; CNC: consonant-nucleus-consonant; CROS: contralateral routing of signal; HINT: Hearing in Noise Test; HL: hearing loss; IT-MAIS: Infant-Toddler Meaningful Auditory Integration Scale; LNT: Lexical Neighborhood Test; MAIS: Meaningful Auditory Integration Scale; MLNT: Multisyllabic Lexical Neighborhood Test; PBK: Phonetically Balanced-Kindergarten; PMA: premarket approval; PTA: pure tone average; SNHL: sensorineural hearing loss; SPL: sound pressure level; SSD: single-sided deafness.

In 2014, the FDA through the premarket approval process approved the Nucleus^® Hybrid^™ L24 Cochlear Implant System (Cochlear Americas). This system is a hybrid cochlear implant and hearing aid, with the hearing aid integrated into the external sound processor of the cochlear implant. It is indicated for unilateral use in patients ages 18 years and older who have residual low-frequency hearing sensitivity and severe-to-profound high-frequency sensorineural hearing loss, and who obtain limited benefit from an appropriately fit bilateral hearing aid. The electrode array inserted into the cochlea is shorter than conventional cochlear implants. According to the FDA’s premarket approval notification, labeled indications for the device include:

• Preoperative hearing in the range from “normal to moderate hearing loss [HL] in the low frequencies (thresholds no poorer than 60 dB HL up to and including 500 Hz)”
• Preoperative hearing with “severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted”
• Preoperative hearing with “moderately severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥60 dB HL) in the contralateral ear”
• “The CNC [Consonant-Nucleus-Consonant] word recognition score will be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition and in the contralateral ear equal to or better than that of the ear to be implanted but not more than 80% correct.”

In 2022, the Nucleus^® Hybrid™ L24 Cochlear Implant System received expanded approval for single-sided deafness or unilateral hearing loss in adults and children age 5 or older (P970051/S205).

Other hybrid hearing devices have been developed. The Med-El EAS System received expanded premarket approval by the FDA in 2016 (PMA P000025/S084).

Although cochlear implants have typically been used unilaterally, interest in bilateral cochlear implantation has arisen in recent years. The proposed benefits of bilateral cochlear implants are to improve understanding of speech occurring in noisy environments and localization of sounds. Improvements in speech intelligibility with bilateral cochlear implants may occur through binaural summation (i.e., signal processing of sound input from 2 sides may provide a better representation of sound and allow the individual to separate noise from speech). Speech intelligibility and localization of sound or spatial hearing may also be improved with head shadow and squelch effects (i.e., the ear that is closest to the noise will receive it at a different frequency and with different intensity, allowing the individual to sort out the noise and identify the direction of sound). Bilateral cochlear implantation may be performed independently with separate implants and speech processors in each ear, or a single processor may be used. However, the FDA for use in the United States has approved no single processor for bilateral cochlear implantation. 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

69930	Cochlear device implantation; with or without mastoidectomy
92507	Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual
92601	Diagnostic analysis of cochlear implant, patient younger than 7 years of age; with programming
92602	Diagnostic analysis of cochlear implant, patient younger than 7 years of age; subsequent programming
92603	Diagnostic analysis of cochlear implant, age 7 years or older; with programming
92604	Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming
92626	Evaluation of auditory function for surgically implanted device(s) candidacy or postoperative status of a surgically implanted device(s); first hour
92627	Evaluation of auditory function for surgically implanted device(s) candidacy or postoperative status of a surgically implanted device(s); each additional 15 minutes (list separately in addition to code for primary procedure)

                                                       

HCPCS:                

L8614	Cochlear device; includes all internal and external components
L8615-L8619; L8625- L8629	Code range for replacement components of cochlear implant device/system
L8621-L8624	Code range for replacement batteries used with cochlear implant device/system

REFERENCES:

1. American Academy of Otolaryngology-Head and Neck Surgery Foundation. Position Statement on Bilateral Cochlear Implants. November 10, 2020. www.entnet.org/resource/position-statement-Cochlear-Implants/.
2. Arndt S, Aschendorff A, Laszig R et al. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol 2011; 32(1):39-47.
3. Arndt S, Prosse S, Laszig R, et al. Cochlear implantation in children with single-sided deafness: does etiology and duration of deafness matter? Audiol Neurootol. 2015; 20 Suppl 1:21-30.
4. Arts RA, George EL, Stokroos RJ et al. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg 2012; 20(5):398-403.
5. Baron S, Blanchard M, Parodi M, et al. Sequential bilateral cochlear implants in children and adolescents: Outcomes and prognostic factors. Eur Ann Otorhinolaryngol Head Neck Dis. Apr 2019; 136(2): 69-73.
6. Benchetrit L, Ronner EA, Anne S, et al. Cochlear Implantation in Children With Single-Sided Deafness: A SystematicReview and Meta-analysis. JAMA Otolaryngol Head Neck Surg. Jan 01 2021; 147(1): 58-69.
7. Berrettini S, Baggiani A, Bruschini L et al. Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in adult patients. Acta Otorhinolaryngol Ital 2011; 31(5):299-310.
8. Bittencourt AG, Ikari LS, Della Torre AA et al. Post-lingual deafness: benefits of cochlear implants vs. conventional hearing aids. Braz J Otorhinolaryngol 2012; 78(2):124-7.
9. Black J, Hickson L, Black B et al. Prognostic indicators in pediatric cochlear implant surgery: a systematic literature review. Cochlear Implants Int May 2011; 12(2):67-93.
10. Blamey PJ, Maat B, Baskent D, et al. A retrospective multicenter study comparing speech perception outcomes for bilateral implantation and bimodal rehabilitation. Ear Hear. Jul-Aug 2015; 36(4):408-416.
11. Blasco MA, Redleaf MI. Cochlear implantation in unilateral sudden deafness improves tinnitus and speech comprehension: meta-analysis and systematic review. Otol Neurotol. Sep 2014; 35(8):1426-1432.
12. Bo D, Huang Y, Wang B, et al. Auditory and Speech Outcomes of Cochlear Implantation in Children With Auditory Neuropathy Spectrum Disorder: A Systematic Review and Meta-Analysis. Ann Otol Rhinol Laryngol. Apr 2023; 132(4):371-380.
13. Bond M, Elston J, Mealing S, et al. Systematic reviews of the effectiveness and cost-effectiveness of multi-channel unilateral cochlear implants for adults. Clin Otolaryngol. Apr 2010; 35(2):87-96.
14. Broomfield SJ, Murphy J, Emmett S et al. Results of a prospective surgical audit of bilateral paediatric cochlear implantation in the UK. Cochlear Implants Int Nov 2013; 14 Suppl 4:S19-21.
15. Brown KD, Dillon MT, Park LR. Benefits of Cochlear Implantation in Childhood Unilateral Hearing Loss (CUHL Trial). Laryngoscope.Mar 2022; 132 Suppl 6(Suppl 6): S1-S18.
16. Buss E, Dillon MT, Rooth MA, et al. Effects of Cochlear Implantation on Binaural Hearing in Adults with Unilateral Hearing Loss. Trends Hear. Jan-Dec 2018; 22:2331216518771173.
17. Causon A, Verschuur C, Newman TA. A retrospective analysis of the contribution of reported factors in cochlear implantation on hearing preservation outcomes. Otol Neurotol. Aug 2015; 36(7):1137-1145.
18. Choi JS, Betz J, Li L, et al. Association of using hearing aids or cochlear implants with changes in depressive symptoms in older adults. JAMA Otolaryngol Head Neck Surg. Jul 01 2016; 142(7):652-657.
19. Cochlear Implants in Adults and Children. NIH Consensus Statement Online 1995 May 15-17; 13(2):1-30. Available online at: consensus.nih.gov/1995/1995CochlearImplants100html.htm.
20. Colletti L, Mandalà M, Zoccante L et al. Infants versus older children fitted with cochlear implants: performance over 10 years. Int J Pediatr Otorhinolaryngol. 2011 Apr; 75(4):504-9. 
21. Crathorne L, Bond M, Cooper C et al. A systematic review of the effectiveness and cost-effectiveness of bilateral multichannel cochlear implants in adults with severe-to-profound hearing loss. Clin Otolaryngol Oct 2012; 37(5):342-54.
22. Dillon MT, Buss E, O'Connell BP, et al. Low-Frequency Hearing Preservation With Long Electrode Arrays: Inclusion of Unaided Hearing Threshold Assessment in the Postoperative Test Battery. Am J Audiol. Mar 05 2020; 29(1): 1-5.
23. Dillon MT, Buss E, Rooth MA, et al. Cochlear Implantation in Cases of Asymmetric Hearing Loss: Subjective Benefit, Word Recognition, and Spatial Hearing. Trends Hear. Jan-Dec 2020; 24: 2331216520945524.
24. Escorihuela Garcia V, Pitarch Ribas MI, Llopez Carratala I, et al. Comparative study between unilateral and bilateral cochlear implantation in children of 1 and 2 years of age. Acta Otorrinolaringol Esp. 2016; 67(3): 148-55.
25. Eze N, Ofo E, Jiang D et al. Systematic review of cochlear implantation in children with developmental disability. Otol Neurotol 2013; 34(8):1385-93.
26. Food and Drud Adminstration. Approval Letter: Nucleus Hybrid L24 Cochlear Implant System -- P130016. 2014. www.accessdata.fda.gov/cdrh_docs/pdf13/P130016a.pdf.
27. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Nucleus 24 Cochlear Implant System(P970051/S205). January 10, 2022; www.accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf.
28. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): MED-EL Cochlear Implant System (P000025/S104). 2019; www.accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf.
29. Food and Drug Administration. Post-Approval Studies (PAS): MED-EL New Enrollment SSD/AHL Study. 2020; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=647845&c_id=5585.
30. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Nucleus 24 Cochlear Implant System (P970051/S172). 2020; www.accessdata.fda.gov/cdrh_docs/pdf/P970051S172B.pdf.
31. Fernandes NF, Morettin M, Yamaguti EH, et al. Performance of hearing skills in children with auditory neuropathy spectrum disorder using cochlear implant: a systematic review. Braz J Otorhinolaryngol. Jan-Feb 2015; 81(1):85-96.
32. Forli F, Arslan E, Bellelli S et al. Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in paediatric patients. Acta Otorhinolaryngol Ital Oct 2011; 31(5):281-98.
33. Friedmann DR, Green J, Fang Y, et al. Sequential bilateral cochlear implantation in the adolescent population. Laryngoscope. Aug 2015; 125(8):1952-1958.
34. Galvin JJ, Fu QJ, Wilkinson EP, et al. Benefits of Cochlear Implantation for Single-Sided Deafness: Data From the House Clinic- University of Southern California-University of California, Los Angeles Clinical Trial. Ear Hear. Jul/Aug 2019; 40(4): 766-781.
35. Gantz BJ, Dunn C, Oleson J, et al. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. Apr 2016; 126(4): 962-73.
36. Gaylor JM, Raman G, Chung M et al. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg Mar 2013; 139(3):265-72.
37. Gifford RH, Dorman MF, Skarzynski H et al. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear 2013; 34(4):413-25.
38. Guerzoni L, Murri A, Fabrizi E, et al. Social conversational skills development in early implanted children. Laryngoscope. Sep 2016; 126(9):2098-2105.
39. Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol 2013; 34(9):1681-7.
40. Harkonen K, Kivekas I, Rautiainen M, et al. Sequential bilateral cochlear implantation improves working performance, quality of life, and quality of hearing. Acta Otolaryngol. May 2015; 135(5):440-446.
41. Humphriss R, Hall A, Maddocks J et al. Does cochlear implantation improve speech recognition in children with auditory neuropathy spectrum disorder? A systematic review. Int J Audiol 2013; 52(7):442-54.
42. Illg A, Giourgas A, Kral A et al. Speech comprehension in children and adolescents after sequential bilateral cochlear implantation with long interimplant interval. Otol Neurotol Jun 2013; 34(4):682-9.
43. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
44. Kamal SM, Robinson AD, Diaz RC. Cochlear implantation in single-sided deafness for enhancement of sound localization and speech perception. Curr Opin Otolaryngol Head Neck Surg 2012; 20(5):393-7.
45. Karltorp E, Eklof M, Ostlund E, et al. Cochlear implants before 9 months of age led to more natural spoken language development without increased surgical risks. Acta Paediatr. Feb 2020; 109(2): 332-341.
46. Kontorinis G, Lloyd SK, Henderson L, et al. Cochlear implantation in children with auditory neuropathy spectrum disorders. Cochlear Implants Int. May 2014; 15 Suppl 1:S51-54.
47. Lammers MJ, van der Heijden GJ, Pourier VE et al. Bilateral cochlear implantation in children: a systematic review and best evidence synthesis. Laryngoscope. July 2014; 124(7): 1694-1699. 
48. Lenarz T, James C, Cuda D et al. European multi-centre study of the Nucleus Hybrid L24 cochlear implant. Int J Audiol Dec 2013; 52(12):838-48.
49. Lyu J, Kong Y, Xu TQ, et al. Long-term follow-up of auditory performance and speech perception and effects of age on cochlear implantation in children with pre-lingual deafness. Chin Med J. Aug 20 2019; 132(16): 1925-1934.
50. Marx M, Mosnier I, Venail F, et al. Cochlear Implantation and Other Treatments in Single-Sided Deafness and Asymmetric Hearing Loss: Results of a National Multicenter Study Including a Randomized Controlled Trial. Audiol Neurootol. 2021; 26(6): 414-424.
51. McRackan TR, Bauschard M, Hatch JL, et al. Meta-analysis of quality-of-life improvement after cochlear implantation and associations with speech recognition abilities. Laryngoscope. Apr 2018; 128(4):982-990.
52. McRackan TR, Bauschard M, Hatch JL, et al. Meta-analysis of Cochlear Implantation Outcomes Evaluated With General Health-related Patient-reported Outcome Measures. Otol Neurotol. Jan 2018; 39(1):29-36.
53. Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. Oct 15 2015; 331:1-6.
54. National Institute for Health and Care Excellence (NICE). Cochlear Implants for Children and Adults With Severe to Profound Deafness [TA566]. 2019; www.nice.org.uk/guidance/ta566/.
55. Oh SJ, Mavrommatis MA, Fan CJ, et al. Cochlear Implantation in Adults With Single-Sided Deafness: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. Feb 2023; 168(2): 131-142.
56. Pakdaman MN, Herrmann BS, Curtin HD, et al. Cochlear implantation in children with anomalous cochleovestibular anatomy: a systematic review. Otolaryngol Head Neck Surg. Feb 2012; 146(2):180-190.
57. Peter N, Kleinjung T, Probst R, et al. Cochlear implants in single-sided deafness - clinical results of a Swiss multicentre study. Swiss Med Wkly. Dec 16 2019; 149: w20171.
58. Peters JPM, van Heteren JAA, Wendrich AW, et al. Short-term outcomes of cochlear implantation for single-sided deafness compared to bone conduction devices and contralateral routing of sound hearing aids-Results of a Randomised controlled trial (CINGLE-trial). PLoS One. 2021; 16(10): e0257447.
59. Pillsbury HC, Dillon MT, Buchman CA, et al. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. Mar 2018; 39(3): 299-305.
60. Poncet-Wallet C, Mamelle E, Godey B, et al. Prospective Multicentric Follow-up Study of Cochlear Implantation in Adults With Single-Sided Deafness: Tinnitus and Audiological Outcomes. Otol Neurotol. Dec 20 2019.
61. Rahne T, Plontke SK. Functional result after cochlear implantation in children and adults with single-sided deafness. Otol Neurotol. Oct 2016; 37(9):e332-340.
62. Raman G, Lee J, Chung M. et al. Effectiveness of cochlear implants in adults with sensorineural hearing loss. Technology Assessment Report. Rockville, MD: Agency for Healthcare Research and Quality; 2011.  
63. Ramos Macias A, Falcon Gonzalez JC, Manrique M, et al. Cochlear implants as a treatment option for unilateral hearing loss, severe tinnitus and hyperacusis. Audiol Neurootol. 2015; 20 Suppl 1:60-66.
64. Roland JT, Gantz BJ, Waltzman SB, et al. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. Aug 2018; 128(8): 1939-1945.
65. Roland JT, Jr., Gantz BJ, Waltzman SB, et al. United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Laryngoscope. Jan 2016; 126(1):175-181.
66. Roush P, Frymark T, Venediktov R et al. Audiologic management of auditory neuropathy spectrum disorder in children: a systematic review of the literature. Am J Audiol 2011; 20(2):159-70.
67. Sampaio AL, Araujo MF, Oliveira CA. New criteria of indication and selection of patients to cochlear implant. Int J Otolaryngol 2011; 2011:573968.
68. Santa Maria PL, Gluth MB, Yuan Y, et al. Hearing preservation surgery for cochlear implantation: a meta-analysis. Otol Neurotol. Dec 2014; 35(10):e256-269.
69. Sarant J, Harris D, Bennet L et al. Bilateral versus unilateral cochlear implants in children: a study of spoken language outcomes. Ear Hear. Jul-Aug 2014; 35 (4): 396-409.
70. Sladen DP, Carlson ML, Dowling BP, et al. Early outcomes after cochlear implantation for adults and children with unilateral hearing loss. Laryngoscope. Oct 12 2016.
71. Sladen DP, Frisch CD, Carlson ML, et al. Cochlear implantation for single-sided deafness: A multicenter study. Laryngoscope. Jan 2017; 127(1):223-228.
72. Smulders YE, Rinia AB, Rovers MM et al. What is the effect of time between sequential cochlear implantations on hearing in adults and children? A systematic review of the literature. Laryngoscope 2011; 121(9):1942-9.
73. Sparreboom M, van Schoonhoven J, van Zanten BG et al. The effectiveness of bilateral cochlear implants for severe-to-profound deafness in children: a systematic review. Otol Neurotol. 2010 Sep; 31(7):1062-71.
74. Sterkers F, Merklen F, Piron JP, et al. Outcomes after cochlear reimplantation in children. Int J Pediatr Otorhinolaryngol. Jun 2015; 79(6): 840-843.
75. Tavora-Vieira D, Marino R, Krishnaswamy J et al. Cochlear implantation for unilateral deafness with and without tinnitus: a case series. Laryngoscope May 2013; 123(5):1251-5.
76. van Schoonhoven J, Sparreboom M, van Zanten BG et al. The effectiveness of bilateral cochlear implants for severe-to-profound deafness in adults: a systematic review. Otol Neurotol 2013; 34(2):190-8.
77. van Zon A, Smulders YE, Ramakers GG, et al. Effect of unilateral and simultaneous bilateral cochlear implantation on tinnitus: A Prospective Study. Laryngoscope. Apr 2016; 126(4): 956-61.
78. van Zon A, Peters JP, Stegeman I, et al. Cochlear implantation for patients with single-sided deafness or asymmetrical hearing loss: a systematic review of the evidence. Otol Neurotol. Feb 2015; 36(2):209-219.
79. Vlastarakos PV, Nazos K, Tavoulari EF, et al. Cochlear implantation for single-sided deafness: the outcomes. An evidence-based approach. Eur Arch Otorhinolaryngol. Aug 2014; 271(8):2119-2126.

POLICY HISTORY:

Medical Review Committee, 1990

MPRM, December 1995

MPRM, July 1997

MPRM, November 1998

MPRM, August 2001

Medical Policy Group, August 2001

Medical Policy Administration Committee, October 2001

TEC, March 2002

Medical Policy Group, August 2002

Medical Policy Administration Committee, August 2002

Available for comment, August 26-October 9, 2002

Medical Policy Group, May 2003 (2)

Medical Policy Administration Committee, June 2003

Available for comment July 1-August 14, 2003

Medical Policy Group, May 2004 (2)

Medical Policy Administration Committee May 2004

Available for comment May 17-June 30, 2004

Medical Policy Group, May 2005 (2)

Medical Policy Administration Committee, June 2005

Available for comment June 7-July 21, 2005

Medical Policy Group, November 2005 (2)

Medical Policy Group, August 2006 (2)

Medical Policy Group, October 2006 (2)

Medical Policy Administration Committee, October 2006

Available for comment October 23-December 6, 2006

Medical Policy Group, February 2008 (2)

Medical Policy Administration Committee, February 2008

Available for comment February 21-April 4, 2008

Medical Policy Panel, February 2010

Medical Policy Group, June 2010 (2)

Medical Policy Group, February 2012 (2): 2011 Update: Key Points & References

Medical Policy Group, July 2012 (2): 2012 Update: Key Points, Approved by Governing Bodies & References

Medical Policy Panel, June 2013

Medical Policy Group, September 2013(2): Added policy statement that cochlear implants are investigational for patients with unilateral hearing loss. Changed age from 8 months to 12 months for coverage for patients with bilateral hearing loss. Approved by Governing Bodies updated with most current available information. Key Point and References updated to support changes in policy statements.  Coding updated to include Speech Therapy codes related cochlear implantation and replacement HCPCS codes added.

Medical Policy Administration Committee, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Group, December 2013 (2): Removed PEEHIP benefit statement re: bilateral implants not being covered.

Medical Policy Group, June 2014, (5):Policy statement added that cochlear implantation with a hybrid cochlear implant/hearing aid system is considered investigational; Description of procedure, Approved by Governing Bodies, Key points and References updated with most current available information. Key words, Key points and References updated to support changes in policy statements.

Medical Policy Administration Committee, June 2014

Available for comment June 17 through July 31, 2014

Medical Policy Group, November 2014, (5): Removed code range L8621-L8624 for replacement batteries from policy. No change to policy statement.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (6): Updates to Key Points, Coding and References; no change to policy statement

Medical Policy Group, December 2015 (6): Updates to Coding with removal of code range L8621-L8624; no change in policy statement.

Medical Policy Panel July 2016

Medical Policy Group, August 2016 (6): Updates to policy statement, removed Nucleus Hybrid L 24 as investigational, updates to Summary, Key Points, Key Words and References.

Medical Policy Administration Committee, August 2016

Available for comment August 16 through September 29, 2016

Medical Policy Group, September 2016 (6): Updated replacement verbiage in policy statement, no change to policy intent.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Key Points, Governing Bodies and References; Removed policy statement from 2013.

Medical Policy Group, December 2017 (6): Removed Nucleus Hybrid L24 from policy statement to not address specific brand in hybrid coverage; Added “FDA approved” to policy statement; Removed old policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new HCPCS code L8625 to code range for replacement batteries under Current Coding. Revised codes L8618 and L8624 are within the range.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Key Points, Practice Guidelines, Coding and References.

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (6): 2019 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Group, August 2019 (6): Updated Policy statement to include non-coverage for lost sound processors.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, added 92626-92627.

Medical Policy Panel, February 2020

Medical Policy Group, March 2020 (6): Updates to Key Points, Governing Bodies, and Practice Guidelines. Removed old policy statement.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (3): 2020 Updates to Key Points and References. Added coverage for pediatric patients 9 months and older with bilateral severe-to-profound pre- or post-lingual (sensorineural) hearing loss, who have shown limited or no benefit from hearing aids.

Medical Policy Administrative Committee, August 2020

Available for comment: July 29, 2020 through September 11, 2020.

Medical Policy Panel, February 2021

Medical Policy Group, March 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements and References. Policy statement updated to remove “not medically necessary, “no other changes to policy statement or intent.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (3): 2022 Updates to Key Points, Approved By Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (6): Updates to Key Points, Governing Bodies, Benefit Application and References.

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9): Removed policy statement for dates of service on and after July 29, 2020. Updates to Key Points, Approved by Governing Bodies, Benefit Application, Current Coding added 92507 and References

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and    

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.