CurrentCignaPolicy 0190

Cochlear and Auditory Brainstem Implants (traditional, hybrid, ABI) coverage

Defines medical necessity criteria, replacements, upgrades, exclusions, and related coverage rules for traditional cochlear implants, hybrid cochlear implants with external hearing aid, auditory brainstem implants, batteries and aural rehabilitation for Cigna-administered health benefit plans. Applies age-specific audiologic thresholds, benefit-from-hearing-aid requirements, and device-specific contraindications.

Policy Summary

PayerCigna

PolicyCochlear and Auditory Brainstem Implants (traditional, hybrid, ABI) coverage

Policy CodePolicy 0190

Change TypeRevised waiver criteria; revised tinnitus coverage statement

Effective DateNov 15, 2024

Next Review DateNov 15, 2025

Key ActionAdults and children should have preoperative evaluation by an audiologist and an otolaryngologist with cochlear implant experience to document reasonable expectation of significant benefit and absence of contraindications.

POLICY UPDATE CHANGES

Revised the policy statement for waiving a hearing aid trial.

Revised the policy statement for a traditional cochlear implant for the treatment of tinnitus.

No policy statement changes noted in prior annual review.

3Device types covered (traditional, hybrid, ABI)

2Battery HCPCS code groups listed

4Key age thresholds mentioned

FDA

Regulatory approvals referenced

2Policy changes noted in 2024 review

Coverage Summary

This policy covers traditional cochlear implants, hybrid (electric‑acoustic) cochlear implants, and auditory brainstem implants (ABI) for Cigna‑administered plans and applies age‑specific audiologic thresholds and device‑specific criteria. Coverage stance is mixed: devices and related components (including batteries) are covered when specified medical‑necessity criteria are met but upgrades of properly functioning systems and implantation solely for tinnitus without qualifying hearing loss are not covered. Key age thresholds include adults (≥ 18 years) for most traditional and hybrid CI indications, children 18 years with pediatric criteria (including age ≥ 5 years for SSD/AHL CI), and ABI candidates age ≥ 12 years. Replacements are covered when a component is nonfunctional or prevents safe daily activities; upgrades to functioning devices are not medically necessary. Post‑implant aural rehabilitation (speech/rehab therapy) is required and considered medically necessary for any age, subject to the plan's short‑term rehabilitative therapy benefit terms.

Key eligibility thresholds

Adult bilateral PTAPTA ≥ 70 dB at 500, 1000, 2000 Hz

Child profound threshold≥ 90 dB at 1000 Hz (children)

Hybrid high‑frequency averageAverage at 2000, 3000, 4000 Hz ≥ 75 dB HL in ear to be implanted

Hybrid contralateral averageContralateral ear average 2000, 3000, 4000 Hz ≥ 60 dB HL

Hybrid CNC preop (ear to be implanted)CNC word score 10%–60% aided preoperative

Hybrid contralateral CNC limitContralateral CNC equal-or-better but ≤ 80%

SSD / AHL age limitAge ≥ 5 years for unilateral SSD/AHL indication

Medical Necessity Criteria (by indication)

Traditional Cochlear Implant — Bilateral Sensorineural Hearing Loss (Initial/Second Implant). Rendered with Adult and Child nodes and operator mappings.

Traditional Cochlear Implant — Initial (Bilateral)

Age-specific pathway
- Adult (≥ 18 years)
  - Bilateral, severe-to-profound sensorineural hearing loss determined by pure-tone average (PTA) ≥ 70 dB at 500, 1000 and 2000 Hz.
  - Limited or no benefit from appropriately fitted hearing aids, defined as ≤ 40% correct in the best-aided listening condition (non-implanted ear aided or binaurally aided) using open-set sentence recognition.
- Child (< 18 years)

Coding

Batteries considered medically necessary for cochlear implantHCPCSCovered

L8621	Zinc air battery for use with cochlear implant device and auditory osseointegrated sound processors, replacement, each.
L8622	Alkaline battery for use with cochlear implant device, any size, replacement, each.
L8623	Lithium ion battery for use with cochlear implant device speech processor; other than ear level, replacement, each.
L8624	Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each.

Batteries considered medically necessary for auditory brainstem implantHCPCSCovered

L7367	Lithium ion battery, rechargeable, replacement.
L8621	Zinc air battery for use with cochlear implant device and auditory osseointegrated sound processors, replacement, each.

Cochlear implantation and related CPT codes considered medically necessary when criteria metCPTCovered

69930	Cochlear device implantation, with or without mastoidectomy.
69949	Unlisted procedure, inner ear (considered medically necessary when used to report removal of a cochlear implant).
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 reprogramming.
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.
92640	Diagnostic analysis with programming of auditory brainstem implant, per hour.
S2235	Implantation of auditory brain stem implant.

HCPCS codes for cochlear device components and replacementsHCPCSCovered

L8614	Cochlear device, includes all internal and external components.
L8615	Headset/headpiece for use with cochlear implant device, replacement.
L8616	Microphone for use with cochlear implant device, replacement.
L8617	Transmitting coil for use with cochlear implant device, replacement.
L8618	Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement.
L8619	Cochlear implant, external speech processor and controller, integrated system, replacement.
L8621	Zinc air battery for use with cochlear implant device and auditory osseointegrated sound processors, replacement, each.
L8622	Alkaline battery for use with cochlear implant device, any size, replacement, each.
L8623	Lithium ion battery for use with cochlear implant device speech processor; other than ear level, replacement, each.
L8624	Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each.

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Provider Actions, Documentation & Billing Notes

Documentation Required

Preoperative audiologic and otolaryngology evaluation

Preoperative audiologic and otolaryngology evaluation must be documented prior to cochlear implantation. Documentation should include audiometric thresholds (pure-tone thresholds and pure-tone averages), duration and onset of hearing loss, and consonant-nucleus-consonant (CNC) scores or other appropriate speech perception measures. Also document aided word recognition in the preoperative aided condition and the results of any ENT evaluation (including imaging when performed) that support candidacy for implantation.

Documentation Required

Hearing aid trial documentation for children

For children, document a trial of appropriately fitted binaural hearing aids unless a waiver applies. The record should include audiometric thresholds, aided speech perception scores, duration of hearing-aid trial, and evidence of participation in intensive aural habilitation when applicable. If a trial is waived, document the rationale (see waiver caveats).

Background and Evidence

Sensorineural hearing loss results from damage to cochlear hair cells or auditory nerve pathways and may be congenital or acquired; severity is quantified by audiometry using pure‑tone averages (PTA) and speech tests. Audiologic evaluation (pure‑tone and speech audiometry, OAEs/ABR as needed) establishes PTA and aided speech recognition; PTA formulations commonly use 500, 1000 and 2000 Hz or the four‑frequency 500–4000 Hz average. Auditory neuropathy spectrum disorder (ANSD) presents with present outer hair‑cell function but abnormal/absent ABR and may benefit from cochlear implantation when inner hair cell dysfunction is suspected. The policy references PTA and CNC/word‑recognition thresholds to define severity and “limited benefit,” notes surgical and device risks (including loss of residual hearing, facial nerve injury, meningitis risk, anesthesia and surgical complications), and supports aural rehabilitation post‑implant to achieve functional benefit.

Study / Source	Key findings
AHRQ technology assessment (2011)	Concluded unilateral cochlear implants effective for adults; bilateral implants provide added benefit for speech perception in noise (n=56 studies).
NIHR Technology Assessment (Bond et al., 2009)	Unilateral and bilateral cochlear implants safe and effective for children and adults; bilateral advantage in noise; studies of moderate to poor quality (33 studies, n=848).
Gantz et al. (2018)	Longitudinal hybrid CI study (n=50) showed maintenance of functional low-frequency hearing for most and improved CNC scores post-implant.
Roland et al. (2016)	Prospective multicenter hybrid L24 study (n=50) with significant CNC and AzBio improvements at 6 months; adverse events included loss of low-frequency hearing in 22 subjects; 34 subjects had 65 adverse events; 34% did not maintain functional acoustic hearing; 10% explant rate.
Gantz et al. multicenter study (S8/S12/L24 series)	Multicenter series (n up to 87) reported 87% improved bilateral word understanding at follow-ups and significant CNC improvements.
Lenarz et al. (2013)	Prospective case series (n=66) reported preservation of low-frequency thresholds in a majority and significant improvements in speech recognition in quiet and in noise at one year.
Hybrid trial pooled/other single-arm studies (Gantz 2016; related trials)	Multiple single-arm and prospective studies report improved speech perception and patient satisfaction but risk of loss of residual hearing; heterogenous small studies with variable follow-up.
Marx et al. (2021) multicenter study	Prospective national multicenter trial in SSD/AHL (n=155 overall; CI group n=51) found CI improved quality-of-life measures (EQ-VAS, NCIQ) and tinnitus VAS; CI superior to CROS/BAHS on several metrics.
Systematic reviews (Peter 2019; Cabral Junior 2016; Kitterick 2016; Cohen & Svirsky 2019)	Generally report improvements in speech perception, localization, and tinnitus suppression with CI vs rerouting devices; limitations due to small, heterogeneous studies.
Colletti ABI outcomes (non-tumor vs tumor)	Retrospective series showed non-tumor ABI recipients had significantly better sentence recognition than tumor (NF2) patients (p=0.0007).
Literature reviews/meta-analyses of unilateral/bilateral CI	Multiple case series and meta-analyses support improved outcomes (speech perception, localization) with unilateral and bilateral CI in adults and children.
Legris et al. (2019) and other small comparative trials	Non-randomized trials indicate CIs can improve comprehension in specific listening conditions compared with rerouting devices; small sample sizes limit conclusions.
Systematic reviews on tinnitus outcomes (Peter 2019; Ramakers 2015)	Some patients experience tinnitus suppression after CI; results variable across studies with methodological limitations.
Cabral Junior et al. (2016)	Systematic review of CI for SSD (n=137) reported improvements in speech discrimination, localization and tinnitus suppression; heterogeneity limited pooling.
Technology assessments and professional society statements	AHRQ and professional societies conclude evidence supports CI effectiveness; recommend timely implantation where appropriate.
ABI literature (Noij 2014; Colletti series)	ABI established for NF2; case series suggest benefit in selected non-tumor indications though evidence is limited and heterogeneous.

FDA premarket approvals referenced include the Nucleus Hybrid L24 and Med‑EL EAS hybrid systems (PMA approvals describing adult candidacy with residual low‑frequency hearing and severe‑to‑profound high‑frequency loss) and the expanded FDA approval of the Med‑El Cochlear Implant System for SSD/AHL (ages ≥ 5 years). The policy notes that specific FDA candidate criteria (e.g., low‑frequency thresholds, mid/high‑frequency averages, CNC/aided speech score ranges, and required hearing‑aid/CROS trial durations) are incorporated into the medical‑necessity criteria and must be documented in preoperative evaluations.

Definitions and Test Thresholds (Reference)

CNCConsonant-Nucleus-Consonant monosyllabic word recognition test (percent correct)

PTA (Pure-Tone Average)Average hearing threshold across specified frequencies (commonly 500, 1000, 2000, 4000 Hz)

SSD (Single-Sided Deafness)Unilateral severe-to-profound deafness: PTA ≥ 70 dB HL with better ear PTA ≤ 30 dB HL

AHL (Asymmetric Hearing Loss)Profound loss in one ear and mild-to-moderately severe in the other; can be defined as PTA difference ≥ 15 dB between ears (better ear PTA 30–55/60 dB HL)

Hybrid CIShort‑electrode cochlear implant combined with external hearing aid to preserve low-frequency acoustic hearing and provide electric stimulation for high frequencies

ABIAuditory Brainstem Implant — electrode array placed on brainstem for patients without a functional auditory nerve (NF2 indication)

Medicare Determinations

Determination	Effective Date / Type
Cochlear Implantation (NCD 50.3)	Effective Date: 2022-09-26 / Type: NCD (National Coverage Determination)
No Local Coverage Determination found	Effective Date / Type: none listed — LCD: none found (policy notes absence of LCD).

Revision History

11/15/2024revisedLatest

Revised the policy statement for waiving a hearing aid trial. (is_material=true)

11/15/2024revisedLatest

Revised the policy statement for a traditional cochlear implant for the treatment of tinnitus. (is_material=true)

Policy Summary

PayerCigna

PolicyCochlear and Auditory Brainstem Implants (traditional, hybrid, ABI) coverage

Policy CodePolicy 0190

Change TypeRevised waiver criteria; revised tinnitus coverage statement

Effective DateNov 15, 2024

Next Review DateNov 15, 2025

On This Page

Profound bilateral sensorineural hearing loss with thresholds ≥ 90 dB at 1000 Hz.

Limited or no benefit from a 3-month trial of appropriately fitted binaural hearing aids defined by age: age ≤ 5 years: lack of progress in development of simple auditory skills despite appropriate amplification and intensive aural habilitation over 3 months; age > 5 years: < 20% correct on open-set sentence discrimination (e.g., MLNT or LNT) depending on cognitive and language ability.

A 3-month binaural hearing aid trial may be waived for children with history of meningitis causing hearing loss or evidence of cochlear ossification on CT/MRI.

Traditional Cochlear Implant — Second (Contralateral) Implant

Age-specific pathway
- Adult (≥ 18 years)
  - Existing unilateral traditional cochlear implant present.
  - Contralateral hearing aid produces limited or no benefit defined as ≤ 40% correct in the best-aided listening condition in the second ear to be implanted on open-set sentence recognition.
  - Bilateral, severe-to-profound sensorineural hearing loss with PTA ≥ 70 dB at 500, 1000 and 2000 Hz.
- Child (< 18 years)
  - Profound bilateral sensorineural hearing loss with thresholds ≥ 90 dB at 1000 Hz.
  - Limited or no benefit from a 3-month trial of an appropriately fitted hearing aid in the ear to be implanted: age ≤ 5 years — lack of progress in simple auditory skills with appropriate amplification and intensive aural habilitation over 3 months; age > 5 years — < 20% correct on open-set sentence discrimination (e.g., MLNT or LNT) in the ear to be implanted, depending on cognitive and language ability.
  - A 3-month trial may be waived for children with history of meningitis causing hearing loss or evidence of cochlear ossification on CT/MRI.

Traditional Cochlear Implant — Unilateral Sensorineural Hearing Loss (SSD/AHL)

Age ≥ 5 years.
Limited benefit from an appropriately fitted unilateral hearing aid in the ear to be implanted.
Diagnostic configuration
- Profound sensorineural hearing loss in one ear and normal or mild sensorineural hearing loss in the other ear (single-sided deafness, SSD).
- Profound sensorineural hearing loss in one ear and mild-to-moderately-severe sensorineural hearing loss in the other ear with ≥ 15 dB PTA difference between ears (asymmetric hearing loss, AHL).

Definitions / Test Score Thresholds (Notes supporting criteria)

For individuals ≥ 18 years, limited benefit from unilateral amplification for SSD/AHL is defined as ≤ 5% correct on monosyllabic CNC words in quiet when tested in the ear to be implanted alone.
For individuals age 5–18 years, insufficient functional access to sound in the ear to be implanted is defined as aided speech perception test scores ≤ 5% correct on developmentally appropriate monosyllabic word lists when tested in the ear to be implanted alone.
Profound hearing loss: PTA ≥ 90 dB HL at 500, 1000, 2000 and 4000 Hz.
Normal hearing: PTA ≤ 15 dB HL at 500, 1000, 2000 and 4000 Hz; Mild hearing loss: PTA ≤ 30 dB HL at those frequencies.
Mild-to-moderately-severe hearing loss: PTA 31–55 dB HL at 500, 1000, 2000 and 4000 Hz.
Adult bilateral severe-to-profound threshold used for CI candidacy: PTA ≥ 70 dB at 500, 1000, 2000 Hz as specified for some adult criteria.

Replacement / Upgrade / Exclusions for Traditional Cochlear Implants

Replacement (medically necessary when ANY of the following)
- Currently used component is no longer functional and cannot be repaired, and there is no evidence of device abuse or neglect.
- Currently used component renders the implant recipient unable to adequately and/or safely perform age-appropriate activities of daily living.
Both initial and replacement batteries (HCPCS L8621, L8622, L8623, L8624) are considered medically necessary.
Upgrading of a properly functioning traditional cochlear implant system or component (e.g., processor upgrade from body-worn to behind-the-ear or upgrading from single- to multi-channel electrodes) is considered not medically necessary.
Traditional cochlear implant for treatment of tinnitus alone, in the absence of profound or severe sensorineural hearing loss warranting CI, is considered not medically necessary.

Hybrid Cochlear Implant with External Hearing Aid — Adults (≥ 18 years)

Limited benefit from appropriately fitted bilateral hearing aids.
Normal to moderate low-frequency hearing (thresholds no poorer than 60 dB HL up to and including 500 Hz).
Severe to profound mid- to high-frequency sensorineural hearing loss in ear to be implanted: threshold average at 2000, 3000, 4000 Hz ≥ 75 dB HL.
Moderately severe to profound mid- to high-frequency hearing loss in contralateral ear: threshold average at 2000, 3000, 4000 Hz ≥ 60 dB HL.
CNC word recognition score in ear to be implanted in preoperative aided condition between 10% and 60%.
CNC word recognition score in contralateral ear equal to or better than ear to be implanted but ≤ 80% correct.
Exclusion: deafness due to lesions of the acoustic nerve or central auditory pathway; active middle ear disease (with or without TM perforation); absence of cochlear development; duration of severe-to-profound hearing loss ≥ 30 years.

Auditory Brainstem Implant (ABI)

Diagnosis of neurofibromatosis type 2 (NF2) or clinical context consistent with ABI candidacy.
Age ≥ 12 years when indicated by criteria.
Tumor/removal context
- ABI placed at time of tumor removal that precludes use of a cochlear implant (e.g., translabyrinthine removal of bilateral vestibular schwannomas).
- ABI considered following prior bilateral tumor removal resulting in nonfunctional cochleae and inability to benefit from cochlear implantation.

Aural Rehabilitation / Speech Therapy

Post-implant aural rehabilitation and speech therapy is considered medically necessary and subject to the member's plan rehabilitative therapy benefit limits.

FDA-specified candidate criteria for CI in SSD/AHL (Med-El approval excerpt)

Prior trial requirement: prior trial with appropriately fitted hearing aid(s) in the ear to be implanted showing limited benefit as defined in policy; age-specific limited benefit definitions apply.
Age-specific limited benefit and benefit definitions and other nested nodes align with SSD/AHL criteria above; limited or no benefit thresholds and age cutoffs preserved.
Some FDA approvals include age-specific limited benefit definitions and limited-duration benefit allowances; consult device-specific labeling for exact trial durations and testing requirements.

FDA candidate criteria for Hybrid Cochlear Implant (Nucleus Hybrid L24 and Med-EL EAS)

CNC word recognition score ranges preserved: preoperative aided CNC in ear to be implanted between 10% and 60%.
Hearing-aid trial requirements: limited benefit from appropriately fitted bilateral hearing aids prior to implantation.
Exclusions: lesions of acoustic nerve or central auditory pathway, active middle ear disease, absence of cochlear development, duration of severe-to-profound hearing loss ≥ 30 years (as listed above).

Hybrid Cochlear Implant Inclusion/Exclusion Criteria (from clinical trials summarized)

Inclusion criteria typically include age ≥ 18, preserved low-frequency hearing (≤ 60 dB HL up to 500 Hz), severe-to-profound high-frequency loss, CNC word recognition in specified range (e.g., 10–60%), and prior hearing-aid trial with limited benefit.
Common exclusion criteria across trials: acoustic nerve/central pathway lesions, active middle ear disease, absence of cochlear development, very long duration (≥ 30 years) of severe-to-profound hearing loss, and medical/surgical contraindications to implantation.

Auditory Brainstem Implant (ABI) FDA Indication

FDA indicates ABI for patients with NF2 in whom cochlear implantation is not possible or not effective due to absence of a functional auditory nerve, typically in the context of tumor resection.

Other ABI Considerations (non-tumor indications from literature)

Other non-tumor indications described in literature include congenital aplasia/hypoplasia of the cochlear nerve, trauma to the cochlear nerve, cochlear ossification where CI is not feasible, and other rare conditions resulting in absent or nonfunctional auditory nerve.
Outcome note: ABI outcomes for non-tumor indications vary and are generally less predictable than cochlear implant outcomes; candidacy requires multidisciplinary evaluation.

Waiver applies for history of meningitis causing the hearing loss

Waiver applies for evidence of cochlear ossification on CT or MRI

Documentation Required

Evidence to support replacement necessity

When requesting replacement of a cochlear implant component or system, document why replacement is necessary. Provide clinical evidence that the current component is nonfunctional, irreparable, or renders the recipient unable to perform age-appropriate activities of daily living. Include device interrogation/diagnostic reports and clinical notes supporting the need for replacement.

Billing Rule

Batteries coverage

Batteries for cochlear implants are covered; bill using the appropriate HCPCS codes. Include supporting documentation that the batteries are for an active cochlear implant system.

L8621
L8622
L8623
L8624
L7367

Documentation Required

Aural rehabilitation coverage conditions

Aural rehabilitation for cochlear implant recipients refers to speech therapy focused on auditory training and/or speech-language therapy to support listening and communication outcomes. Coverage is subject to the member's plan limits for speech therapy services and should be documented with treatment goals and progress.

Documentation Required

Demonstrate limited benefit from amplification

Document limited benefit from amplification with objective speech perception test results and the duration of any hearing-aid trial. For adults, provide CNC word scores; for children, provide developmentally appropriate monosyllabic word lists. Include documentation of the best-aided listening condition when required.

Consonant-Nucleus-Consonant (CNC) word test or developmentally appropriate monosyllables
Trial durations: three-month appropriately fitted binaural hearing aid trial for most children (unless waived); documented hearing-aid use and habilitation participation

Denial Risk

Failure to meet FDA-specified preoperative criteria

Failure to meet FDA-specified preoperative criteria or failure to document required preoperative findings (e.g., audiometric thresholds, aided CNC or aided word recognition scores, duration and onset of hearing loss) increases the risk of denial. Ensure all required measures and supporting documentation are included with the request.

Document audiometric thresholds and pure-tone averages
Document aided word recognition and CNC scores where applicable
Record duration and onset of hearing loss

Billing Rule

Use appropriate CPT/HCPCS for implantation and components

Use appropriate CPT and HCPCS codes when reporting implantation procedures and related components. Ensure claims include the correct procedure code(s) for implantation and the applicable HCPCS codes for external components and accessories.

Include comprehensive set of CPT/HCPCS codes for implantation, components, and accessories as applicable when filing claims

Documentation Required

Waiver of hearing aid trial

Waiver of the hearing aid trial for children is permitted per policy revision. When the trial is waived, clearly document the clinical rationale (e.g., post-meningitis ossification on imaging or clinical history of meningitis) in the medical record.

Documentation Required

Cochlear implant for tinnitus

Policy revision clarifies that cochlear implantation for tinnitus alone—without qualifying severe or profound sensorineural hearing loss meeting implantation criteria—is considered not medically necessary. Document the indication for implantation and ensure tinnitus alone is not the sole justification.

Limited benefit (adults, bilateral CI)≤ 40% correct in best‑aided listening condition on open‑set sentence recognition

Limited benefit (children >5)< 20% correct on open‑set sentence discrimination (e.g., MLNT or LNT)

Limited benefit (SSD adults unilateral)≤ 5% correct on monosyllabic CNC words in quiet when tested in the ear to be implanted alone