Hearing Aids and Devices Including Wearable, Bone-Anchored, and Semi-Implantable

Coverage Summary

Scope: This policy governs medical necessity coverage for wearable air-conduction hearing aids and a range of implantable and non-implantable bone-conduction and semi-implantable electromagnetic hearing devices, lists device types considered unproven/not medically necessary, provides device-specific FDA indications and audiometric thresholds, and includes applicable CPT/HCPCS/V codes. Coverage stance: mixed — wearable air-conduction hearing aids are established as medically necessary; many bone-anchored and semi-implantable devices are covered when used per FDA labeling and device-specific criteria; a subset of devices (intraoral bone-conduction, laser/light-driven contact hearing aids, and totally implanted middle ear systems) are identified as unproven or not medically necessary due to insufficient or inconsistent evidence.

Quick eligibility thresholds & facts

Common hearing loss bands (PTA categories)Normal: -10 to 15 dBHL; Slight: 16–25 dBHL; Mild: 26–40 dBHL; Moderate: 41–55 dBHL; Moderately severe: 56–70 dBHL; Severe: 71–90 dBHL; Profound: >=91 dBHL

SSD (single-sided deafness) definitionContralateral AC PTA <= 20 dB HL (0.5,1,2,3 kHz) = normal hearing

Common PTA BC device bandsBP100/Baha4/Baha5: PTA BC <=45 dB HL; BP110/Baha5 Power/Osia (some): PTA BC <=55 dB HL; Cordelle II/Baha5 SuperPower: PTA BC <=65 dB HL

ADHEAR / non-implantable headband bandADHEAR: PTA BC <=25 dB HL (0.5,1,2,3 kHz)

Symmetry requirements for bilateral fittingLeft-right BC difference <10 dB average (0.5,1,2,3 kHz) OR <15 dB at individual frequencies

Vibrant Soundbridge audiometric thresholdsAC PTA ranges by frequency: 500 Hz 30–65 dB; 1 kHz 40–75 dB; 1.5 kHz 45–80 dB; 2 kHz 45–80 dB; 3 kHz 50–85 dB; 4 kHz 50–85 dB; Word recognition >=50% (recorded)

Equipment upgrades noteEquipment upgrades are equivalent to a new service and require the same criteria/documentation as new requests

Medical Necessity Criteria

Covered when ALL of the following are met:

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citations":[],"intro":"Not medically necessary / Unproven:","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"Intraoral bone conduction Hearing Aids (intraoral devices) — considered unproven and not medically necessary due to insufficient evidence of efficacy.\"},{\"text\":\"Laser or light-based Hearing Aids — considered unproven and not medically necessary.\"},{\"text\":\"Totally implanted middle ear hearing systems — considered unproven and not medically necessary due to insufficient evidence of long-term effectiveness compared with alternatives.\"}]}"],"title":"Not medically necessary / Unproven","type":"criteria_group"},{"citations":[],"intro":"Equipment upgrades:","nodes":["{\"operator\":\"all\",\"children\":[{\"text\":\"Equipment upgrades are treated as a new service and require the same medical necessity criteria as an initial request.\"},{\"text\":\"A change in the member's medical condition and equipment needs requires documentation and the same criteria as a new request.\"},{\"text\":\"Replacement or upgrade requests must include justification for the upgrade, documentation of prior device performance, and evidence that the upgrade is clinically necessary rather than elective.\"}]}"],"title":"Equipment upgrades","type":"criteria_group"},{"citations":[],"intro":"FDA Indications and Selection Criteria (device-specific):","nodes":["{\"operator\":\"any\",\"children\":[{\"label\":\"Vibrant Soundbridge (partially implantable middle-ear device)\",\"operator\":\"any\",\"children\":[{\"text\":\"Indicated per FDA labeling for appropriate patients with sensorineural or mixed hearing loss when selection criteria are met and alternative options are not suitable.\"},{\"text\":\"Selection should follow device-specific audiometric and clinical criteria per the manufacturer and FDA labeling.\"}]},{\"label\":\"Maxum (partially implantable/BAHA-related devices)\",\"operator\":\"any\",\"children\":[{\"text\":\"Indicated when FDA-labeled criteria are met; device-specific audiometric thresholds and candidacy requirements must be documented.\"}]},{\"label\":\"BAHA (bone-anchored hearing aid) — general\",\"operator\":\"any\",\"children\":[{\"text\":\"Indicated for conductive or mixed hearing loss, or single-sided deafness in patients who are not candidates for conventional air-conduction hearing aids, per FDA labeling. \"},{\"text\":\"Includes fully or partially implantable osseointegrated systems and external sound processors or headband/adhesive-mounted processors when appropriate.\"}]},{\"label\":\"Partially implanted examples (Vibrant Soundbridge, Osia/Osia2, others)\",\"operator\":\"any\",\"children\":[{\"text\":\"Indications depend on device-specific FDA approval and labeling; candidacy requires documented audiometric and medical justification.\"}]},{\"label\":\"Osia / Osia2 (active osseointegrated systems)\",\"operator\":\"any\",\"children\":[{\"text\":\"Indicated per FDA labeling for bone conduction amplification in patients meeting audiometric and clinical selection criteria; documentation of non-candidacy for air-conduction aids when applicable is required.\"}]}]}"],"title":"FDA Indications and Selection Criteria","type":"criteria_group"},{"citations":[],"intro":"FDA Indications and Audiometric Criteria for Bone-Conduction and Related Devices:","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"Specific device audiometric thresholds (examples): BP100/BP110/Cordelle and similar bone-conduction processors must meet device-specific aided and unaided threshold requirements per manufacturer and FDA labeling.\"},{\"text\":\"Bilateral fitting symmetry rules: bilateral devices are appropriate when binaural conductive or mixed hearing loss exists and when binaural benefit is expected; unilateral fitting may be appropriate for single-sided deafness (SSD) with documentation.\"},{\"text\":\"Single-sided deafness (SSD): defined as severe-to-profound sensorineural hearing loss in one ear with normal or near-normal hearing in the contralateral ear; candidacy for bone-conduction solutions for SSD should follow FDA labeling and documented functional impairment.\"}]}"],"title":"FDA Indications and Audiometric Criteria for Bone-Conduction and Related Devices","type":"criteria_group"},{"citations":[],"intro":"Non-Implantable Bone-Conduction Hearing Aid (Softband / Headband / Adhesive):","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"Non-implantable bone-conduction devices (softband, headband, adhesive) are indicated for patients who are not candidates for air-conduction hearing aids or who require a non-surgical option; include systems such as Otomag, ADHEAR, and similar adhesive transducer systems.\"},{\"text\":\"Indications include conductive or mixed hearing loss, temporary use in children prior to implantation, or as a trial prior to consideration of a surgically implanted osseointegrated device.\"},{\"text\":\"Documentation must include audiometric evidence of benefit or need, clinical rationale for non-implantable selection, and, when applicable, reasons why an osseointegrated implant is not appropriate at the time of request.\"}]}"],"title":"Non-Implantable Bone-Conduction Hearing Aid (Softband / Headband / Adhesive)","type":"criteria_group"}],

Background and Evidence Summary

Background: The policy defines device classifications including air-conduction hearing aids (standard wearable amplifying devices), bone-conduction/bone-anchored hearing aids (fully implantable percutaneous devices or partially implantable transcutaneous magnetic coupling systems), semi-implantable electromagnetic middle-ear hearing aids (e.g., Vibrant Soundbridge, Maxum), and totally implantable middle ear systems (e.g., Esteem, Carina). The evidence base summarized in the policy includes systematic reviews, meta-analyses, cohort and case series studies, and HTA reports (e.g., Cochrane review for air-conduction aids; systematic reviews and ECRI/HTA assessments for bone-conduction and transcutaneous devices), which generally support effectiveness for many bone-anchored and semi-implantable devices for conductive, mixed loss and single-sided deafness, while randomized controlled trials and high-quality comparative evidence are limited for some device classes.

Evidence Source	Key Finding
Cochrane review (Ferguson et al. 2017)	Hearing aids are effective for improving hearing-specific and general health-related quality of life and listening ability in adults with mild to moderate hearing loss (5 RCTs, 825 participants).
ECRI (2024) Bonebridge assessment	Low-quality evidence shows Bonebridge improves hearing vs unaided in adults and children ≥12 with conductive/mixed loss or SSD; no definitive comparative conclusions.
Systematic reviews: pTCBI / active transcutaneous devices (Magele et al. 2019; Cooper & McDonald 2017)	Report audiologic benefit, high patient satisfaction and low complication rates for active/transcutaneous bone conduction devices; pooled pTCBI major complications ~5.2% and minor ~13.1%; weighted mean PTA gain ~28.4 dB and SRT gain ~32.9 dB.
pTCBI complications systematic review (Cooper & McDonald 2017)	Major complications 5.2%; minor complications 13.1%; mean PTA gain ~28.4 ±2.1 dB; mean SRT gain ~32.9 ±3.9 dB.
Earlens studies (Gantz et al. 2017; Arbogast et al. 2019)	Single-arm and multi-site studies show mean functional gain ~31 dB (2–10 kHz) and improved word recognition (~35% RAU); studies limited by lack of blinded concurrent controls.
Totally implanted AMEI studies (Shohet 5‑year; Barbara et al.; Pulcherio 2014)	Some long-term improvements in SRT/WRS vs baseline aided; device-specific ADEs/SADEs reported (e.g., 3 SADEs and 15 ADEs in Shohet); evidence limited by lack of controlled trials and mixed outcomes.
Carina retrospective (Peixoto 2019/2023) / systematic reviews of fully implantable MEDs	Small retrospective series report functional gain ~15–20 dB at 1 year (greater in mixed loss) but studies lack comparators and have small samples; overall evidence insufficient and conflicting.
FDA 510(k)/PMA documents and device approvals (Vibrant, Maxum, BAHA, Bonebridge, Osia, Earlens, Esteem, SoundBite)	Multiple device-specific FDA clearances/approvals with labeled selection criteria and audiometric thresholds (e.g., Vibrant/Maxum adult selection, BAHA/Bonebridge PTA BC thresholds, Earlens clearance for 18+).
Systematic reviews / BAHA evidence (Kim 2017; Colquitt 2011; Janssen 2012)	BAHAs improve speech discrimination in noise and quality-of-life measures for conductive/mixed loss and SSD; evidence often observational with variable quality but supports BAHA as reasonable option.
Intraoral Bone Conduction (SoundBite) evidence	Studies (e.g., Gurgel 2015) report patient-reported benefit for SSD but evidence limited by small, nonrandomized trials, withdrawals, and device-related problems; manufacturing ceased after bankruptcy.
AAO-HNS and HTA statements (AAO-HNS position, Ontario Health) / HTAs (Hayes)	Professional and HTA reviews support use of active middle ear implants and bone conduction devices for selected patients; HTAs find implants likely to improve hearing thresholds, speech in noise, and hearing-specific quality of life.
Vibrant Soundbridge / SEHA systematic reviews (Bruchhage 2017; Butler 2013)	Active middle ear implants (Vibrant VSB) generally improve speech perception and patient-reported outcomes and are considered a reliable safe option in appropriately selected patients; comparative outcomes vs hearing aids vary.
Ontario Health Technology Assessment (2020)	Bone-conduction implants compared with no intervention likely yield large improvements in hearing thresholds, speech perception in noise, and hearing-specific quality of life for conductive/mixed loss and SSD (but not necessarily localization).
Selected device-class systematic reviews and HTAs (references list)	Multiple systematic reviews and HTAs cited across policy support varied levels of evidence by device class; overall evidence quality is variable and stronger for bone-anchored and some semi-implantable devices than for intraoral or totally implantable systems.

Coding

Bone Anchored Hearing Aids (BAHA) CPTCPT

69710	Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
69714	Implantation, osseointegrated implant, skull; with percutaneous attachment to external speech processor
69716	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or resulting in removal of less than 100 sq mm surface area of bone deep to the outer cranial cortex
69717	Replacement (including removal of existing device), osseointegrated implant, skull; with percutaneous attachment to external speech processor
69719	Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or involving a bony defect less than 100 sq mm surface area of bone deep to the outer cranial cortex
69729	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside of the mastoid and resulting in removal of >=100 sq mm surface area of bone deep to the outer cranial cortex
69730	Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside the mastoid and involving a bony defect >=100 sq mm surface area of bone deep to the outer cranial cortex

Fitting and Testing CPTCPTCovered

92590	Hearing aid examination and selection; monaural
92591	Hearing aid examination and selection; binaural
92592	Hearing aid check; monaural
92593	Hearing aid check; binaural
92594	Electroacoustic evaluation for hearing aid; monaural
92595	Electroacoustic evaluation for hearing aid; binaural

Semi-Implantable Electromagnetic Hearing Aids CPT / UnlistedCPT

69799

Unlisted procedure, middle ear

Totally Implantable Active Middle Ear Hearing Implants CPT (listed as unproven)CPT

0951T	Totally implantable active middle ear hearing implant; initial placement, including mastoidectomy, placement of and attachment to sound processor
0952T	Totally implantable active middle ear hearing implant; revision or replacement, with mastoidectomy and replacement of sound processor
0953T	Totally implantable active middle ear hearing implant; revision or replacement, without mastoidectomy and replacement of sound processor
0954T	Totally implantable active middle ear hearing implant; replacement of sound processor only, with attachment to existing transducers
0955T	Totally implantable active middle ear hearing implant; removal, including removal of sound processor and all implant components

BAHA HCPCS / L-codesHCPCS

L8690	Auditory osseointegrated device, includes all internal and external components
L8691	Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each
L8693	Auditory osseointegrated device abutment, any length, replacement only
L8694	Auditory osseointegrated device, transducer/actuator, replacement only, each
L8692	Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment

Fitting and Testing HCPCS / S & V codesHCPCSCovered

S0618	Audiometry for hearing aid evaluation to determine the level and degree of hearing loss
V5010	Assessment for hearing aid
V5011	Fitting/orientation/checking of hearing aid
V5014	Repair/modification of a hearing aid
V5020	Conformity Evaluation
V5264	Ear mold/insert, not disposable, any type
V5265	Ear mold/insert, disposable, any type
V5275	Ear impression, each
V5298	Hearing aid, not otherwise classified
V5095	Semi-implantable middle ear hearing prosthesis

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Wearable Hearing Aids HCPCS / V codes (many device types listed)HCPCS

L8692	Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment
V5030	Hearing aid, monaural, body worn, air conduction
V5040	Hearing aid, monaural, body worn, bone conduction
V5050	Hearing aid, monaural, in the ear
V5060	Hearing aid, monaural, behind the ear
V5070	Glasses, air conduction
V5080	Glasses, bone conduction
V5100	Hearing aid, bilateral, body worn
V5120	Binaural, body
V5130	Binaural, in the ear

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FDA device clearances and model references (informational, not billing codes)mixed

P990052	Vibrant Soundbridge PMA reference
P010023	Maxum Hearing Implant PMA reference
K984162	Branemark/BAHA clearance
K090720	BAHA BP100 510(k)
K082108	OBC Bone Anchored Hearing Aid System 510(k)
K121228	Ponto Bone Anchored Hearing System 510(k)
K211640	Ponto 5 Mini 510(k)
K102199	Sophono Otomag Alpha 1 clearance
K131240	Cochlear Baha Attract 510(k)
DEN170009	Bonebridge de novo decision

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Applicable CPT / HCPCS Codes (updated)mixed

0951T	Quarterly updated CPT - device/procedure code added per policy history
0952T	Quarterly updated CPT - device/procedure code added per policy history
0953T	Quarterly updated CPT - device/procedure code added per policy history
0954T	Quarterly updated CPT - device/procedure code added per policy history
0955T	Quarterly updated CPT - device/procedure code added per policy history

Provider Actions & Billing Guidance

Documentation Required

Medical records documentation may be required

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage; documentation does not guarantee coverage.

Billing Rule

Manual review for V5267

For plans that cover hearing aids, code V5267 (hearing aid or assistive listening device/supplies/accessories, not otherwise specified) requires manual review to determine the item before a coverage determination is made.

V5267

Definitions & Thresholds

Definitions / key terms: Conductive Hearing Loss — sound not conducted efficiently through the outer/middle ear and often correctable medically or surgically; Sensorineural Hearing Loss (SNHL) — damage to inner ear or nerve pathways, usually not surgically correctable; Mixed Hearing Loss — combination of conductive and sensorineural loss; Hearing Aids — sound-amplifying devices (including semi-implantable electromagnetic and bone-anchored devices as classified by FDA); Single-Sided Deafness (SSD) — profound unilateral sensorineural loss with normal contralateral hearing (contralateral AC PTA <= 20 dB HL at 0.5,1,2,3 kHz); PTA BC — pure tone average of bone conduction thresholds at 0.5, 1, 2 and 3 kHz; Symmetric loss (bilateral fitting) — left-right BC difference < 10 dB average (0.5,1,2,3 kHz) or < 15 dB at individual frequencies; Pure Tone Average (PTA) — average hearing threshold used to assess device candidacy; PTA BC eligibility thresholds vary by device (commonly <= 45 dB HL, <= 55 dB HL, or <= 65 dB HL depending on processor/implant).

Device-specific PTA & candidacy quick reference

BP100 / Baha4 / Baha5 (Softband/implant)PTA BC <=45 dB HL (0.5,1,2,3 kHz) — bilateral fitting requires symmetry (<10 dB avg or <15 dB per freq)

BP110 Power / Baha5 PowerPTA BC <=55 dB HL (0.5,1,2,3 kHz)

Cordelle II / Baha5 SuperPowerPTA BC <=65 dB HL (0.5,1,2,3 kHz)

Evidence-based Conclusions by Device Class

Evidence summary and coverage tie-in: The evidence supports established coverage for wearable air-conduction hearing aids (Cochrane review) and indicates that many bone-anchored and transcutaneous implant devices (percutaneous BAHA, pTCBI/active transcutaneous devices, partially implanted magnetic systems) demonstrate audiologic benefit, improved quality of life, and acceptable complication rates when used within FDA-labeled indications and device-specific audiometric thresholds. Semi-implantable electromagnetic middle-ear implants have supportive systematic-review evidence for selected SNHL patients. In contrast, evidence for intraoral bone conduction devices, some laser/light-driven systems, and totally implanted middle ear systems is limited, inconsistent, or of low quality, and these device types are designated as unproven/not medically necessary pending more robust comparative data.

Other Device Approvals / Status

FDA device clearances and model references (informational, not billing codes)mixed

P990052	Vibrant Soundbridge PMA reference
P010023	Maxum Hearing Implant PMA reference
K984162	Branemark/BAHA clearance
K090720	BAHA BP100 510(k)
K082108	OBC Bone Anchored Hearing Aid System 510(k)
K121228	Ponto Bone Anchored Hearing System 510(k)
K211640	Ponto 5 Mini 510(k)
K102199	Sophono Otomag Alpha 1 clearance
K131240	Cochlear Baha Attract 510(k)
DEN170009	Bonebridge de novo decision

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Revision History

08/01/2025code_update

Policy effective date 08/01/2025; applicable CPT codes updated to reflect quarterly edits and addition of 0951T–0955T; prior version CS052.T archived.

11/01/2025scope_clarification

Application updated to indicate the policy does not apply to Nebraska; refer to state-specific Nebraska policy version.

04/01/2026template_updateLatest

Template update removed content/language pertaining to Louisiana.