CurrentUnitedHealthcarePolicy CS052KY.12

Hearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

UnitedHealthcare Community Plan medical policy CS052KY.12 governing coverage, medical necessity references, definitions, applicable procedure and supply codes, and evidence summaries for wearable air-conduction hearing aids, bone-anchored/bone conduction devices, semi-implantable electromagnetic hearing aids, intraoral bone conduction aids, laser/light-based hearing aids, and totally implanted middle ear systems for Kentucky members.

Policy Summary

PayerUnitedHealthcare

PolicyHearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

Policy CodePolicy CS052KY.12

Change TypeUpdates to documentation language, definitions, code removals, and section updates

Effective DateJun 1, 2026

Next Review Date

Key ActionMaintain complete, legible medical record documentation (history, physical exam, diagnostic test results) to support requested services and make available upon request.

POLICY UPDATE CHANGES

Added language clarifying medical records documentation used for reviews and that documentation may be required to assess clinical criteria but does not guarantee coverage.

Updated definition of 'Conductive Hearing Loss'.

Removed list of applicable CPT/HCPCS codes for Fitting and Testing of Hearing Aids (92590, 92591, 92592, 92593, 92594, 92595, S0618, V5010, V5011, V5014, V5020, V5264, V5265, V5275).

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information; archived previous policy version CS052KY.11.

3Device categories stated as medically necessary (with InterQual reference)

3Device categories listed as unproven / not medically necessary

100+Applicable CPT/HCPCS/V codes listed

MultipleFDA-cleared device families discussed

Examples: 5+Devices with explicit age thresholds referenced

RemovedCPT/HCPCS codes removed in latest revision

Coverage Summary

UnitedHealthcare Community Plan policy CS052KY.12 covers wearable air-conduction hearing aids, bone-anchored/bone-conduction devices, and semi-implantable electromagnetic hearing aids for Kentucky members and references InterQual clinical criteria for medical necessity determinations. The policy stance is mixed: wearable air-conduction hearing aids are stated as proven and medically necessary with InterQual cited, while some device categories are identified as unproven and not medically necessary. The brief supports these positions with multiple evidence summaries and device- or FDA-related references; policy statistics enumerate 3 device categories considered medically necessary and 3 device categories listed as unproven/not medically necessary (per the brief stats).

Coverage Rationale and Medical Necessity References

Policy statements and clinical coverage references for different device categories:

ALL of the following

Jurisdiction note (Kentucky Application): Policy applies only to the state of Kentucky (Application).
Kentucky program coverage reference: For program coverage provisions and requirements, refer to Kentucky Administrative Regulations (KAR), Title 907, Chapter 001, Regulation 038: Hearing program coverage provisions and requirements.
InterQual references - Wearable air-conduction: Wearable air-conduction hearing aids required for correction of a Hearing Impairment are proven and medically necessary; for medical necessity clinical coverage criteria, refer to the InterQual CP: Durable Medical Equipment, Hearing Aids.
Click here to view the InterQual criteria.
InterQual references - Bone anchored / bone conduction: Bone anchored hearing aid / bone conduction hearing aid: medical necessity criteria per InterQual CP: Procedures: Hearing Device, Bone Anchored or Bone Conduction (Adult and Pediatric).
Click here to view the InterQual criteria.
InterQual references - Semi-implantable: Semi-implantable hearing aids: medical necessity criteria per InterQual CP: Procedures, Hearing Device, Middle Ear.
Click here to view the InterQual criteria.
Unproven / Not Medically Necessary
- Intraoral BCHAs: Intraoral bone conduction hearing instruments are unproven and not medically necessary due to insufficient evidence of efficacy.
- Laser/light-based devices: Laser or light-based hearing instruments are unproven and not medically necessary due to insufficient evidence of efficacy.
- Totally implanted middle ear devices: Totally implanted middle ear hearing instruments are unproven and not medically necessary due to insufficient evidence of efficacy.

Medical Necessity Criteria & Documentation

Medical Records Documentation

{

"operator":"all","children":[

{"text":"Relevant medical history, including prior treatments and response"},

{"text":"Comprehensive otologic and audiologic physical examination"},

{"text":"Audiometric test results (pure tone audiometry, speech recognition scores) demonstrating hearing thresholds and configuration"},

{"text":"Verification of device-specific audiometric thresholds and age criteria (include device manufacturer requirements and any pediatric thresholds as applicable)"},

Device Selection & FDA Indications (Informational)

FDA / Device Selection Criteria (informational)

Selection criteria extracted from professional labeling (FDA) for specific devices:

Vibrant Soundbridge selection criteria (adults ≥18 years): pure-tone air conduction thresholds 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 Score ≥50%; normal middle ear anatomy; psychologically and motivationally suitable.

Refer to professional labeling on FDA website.

MAXUM Hearing Implant (adults ≥18 years): audiological results consistent with moderate to severe sensorineural hearing loss; desire for an alternative to an acoustic hearing device; prior experience with appropriately fit hearing aids.

Refer to professional labeling on FDA website.

BAHA System indications: adults and children (≥5 years) with external ear malformations, chronically draining ear, pure-tone threshold ≥45 dB and/or inability/unwillingness to use air conduction aid; broadened indications include bilateral implantation for bilateral conductive/mixed losses meeting symmetry criteria or SSD/unilateral SNHL for selected patients.

Refer to FDA clearances and device-specific 510(k) documents.

Not Medically Necessary / Unproven Devices

Unproven / Not Medically Necessary

The following device categories and instruments are considered unproven or not medically necessary due to insufficient quality evidence of efficacy:

Intraoral bone conduction hearing instruments (e.g., SoundBite) are unproven and not medically necessary due to insufficient quality evidence, small study sizes, short follow-up, lack of randomization, and lack of control groups.

Studies include Gurgel et al. (2015) and others; manufacturer ceased production of SoundBite.

Laser or light-based hearing instruments (e.g., Earlens Contact Hearing Device) are unproven and not medically necessary due to limited evidence and lack of concurrent control groups despite FDA clearance for some devices.

Studies include Arbogast et al. (2019) and Gantz et al. (2017).

Totally implanted middle ear hearing instruments (e.g., Esteem, Carina) are unproven and not medically necessary due to insufficient high-quality comparative evidence, conflicting findings, and reported safety concerns.

Evidence assessments include ECRI (2025) and multiple systematic reviews and case series.

CPT / HCPCS / Category III Codes

CPT / HCPCS / Category III Codes referenced (procedures and devices)mixed

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	Revision or 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 greater than or equal to 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 greater than or equal to 100 sq mm surface area of bone deep to the outer cranial cortex.
69799	Unlisted procedure, middle ear.
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.

1–10 of 65

1/7

Removed applicable CPT/HCPCS codes (Fitting and Testing of Hearing Aids) per 06/01/2026 revisionmixed

92590	Fitting and adjustment of hearing aid
92591	Hearing aid check
92592	Hearing aid check
92593	Hearing aid check
92594	Electronic analysis of cochlear implant
92595	Hearing aid check
S0618	Hearing aid batteries (example)
V5010	Dispensing fee, hearing aid
V5011	Hearing aid, monaural
V5014	Hearing aid, binaural

1–10 of 14

1/2

Billing Rule

Removed Codes — Effective 06/01/2026

The June 1, 2026 policy revision removed a set of CPT and HCPCS codes that had previously been listed for fitting and testing of hearing aids. Providers should refer to their plan's billing manuals, coding guidance, or prior authorization workflows for the current, approved codes and coding guidance when billing for fitting, testing, or related services.

Specified fitting/testing CPT and HCPCS codes were removed in the 06/01/2026 revision; refer to plan billing manuals or PA workflows for current coding guidance

Provider Actions & Prior Authorization

Prior Authorization

State Regulatory Requirements / Prior Authorization

Follow state regulatory requirements and any applicable contractual rules that may require prior authorization for hearing devices or services. The policy applies to Kentucky and refers specifically to Kentucky Administrative Regulations (KAR), Title 907, Chapter 001, Regulation 038 for program coverage provisions and requirements; state or contractual rules may require prior authorization in addition to policy criteria.

KAR Title 907 Chapter 001 Regulation 038 may include prior authorization or state-mandated criteria
State and contractual rules govern and may require prior authorization

Documentation Required

Maintain Medical Records & Audiometric Data

Maintain complete, legible medical records and audiometric documentation to support requests for hearing devices. Records should be retained in the patient's chart and made available upon request. When seeking coverage for device-specific devices, document pure-tone average (PTA) bone and air conduction thresholds at the frequencies specified by the device labeling and the patient’s age to confirm device-specific indications.

Evidence Summary

The evidence review underlying this policy is characterized by limited study designs (single‑arm trials, case series, small sample sizes), short follow‑up, and lack of randomized controlled or well‑matched comparative studies. The brief’s overall theme is that while some devices have FDA clearances or approvals and professional society statements note potential appropriateness for selected patients, the available clinical evidence for intraoral BCHAs, laser/light devices, and totally implanted middle‑ear systems is of insufficient quality to establish comparative effectiveness and long‑term safety definitively.

Study / Source	Key Finding
Gurgel et al. (2015)
Prospective case series of the SoundBite intraoral BCHA (81 adults) reported subjective benefits on APHAB and high satisfaction at 6–12 months but had no control group, small limitations, and potential selection/response biases — evidence considered low quality and insufficient to support efficacy.
Arbogast et al. (2019)
Single-arm, multi-site studies (78 participants) of the Earlens light-driven contact hearing device showed significant APHAB improvements versus unaided listening and small improvements versus participants' own hearing aids; studies were unblinded and lacked concurrent controls, limiting strength of evidence.
Gantz et al. (2017)
Pivotal single-arm trial (43 participants) of the Earlens contact hearing aid demonstrated safety (no change in residual hearing) and improvements in aided word recognition and functional gain, supporting FDA clearance but authors recommended comparative studies.
ECRI (2025)
ECRI clinical evidence assessment concluded evidence for the Esteem totally implanted middle-ear implant is insufficient in quantity and quality to support definitive comparative effectiveness conclusions; safety concerns (including reported serious adverse events) were noted.
FDA references (510(k)/PMA)
Multiple device-specific FDA clearances/approvals cited (e.g., Earlens 510(k) 2016; Vibrant Soundbridge PMA 2000; BAHA clearances including pediatric and SSD expansions; Otomag, Baha Attract, BONEBRIDGE, Osia/Osia 2, Cochlear Baha 7) with device-specific age and audiometric selection criteria listed in labeling.
Guidelines / Professional Statements (AAO-HNS) and Systematic Reviews
AAO-HNS position statements consider active middle-ear implants and bone conduction devices appropriate for selected adults; systematic reviews note limited, heterogeneous, and generally low-quality evidence for fully implantable middle-ear devices and call for better-controlled studies.

Definitions

Definitions (policy terms)

Conductive Hearing Loss (term)Occurs when sound is not conducted efficiently through the outer ear canal to the eardrum and the ossicles of the middle ear; often correctable medically or surgically (ASHA).

Sensorineural Hearing Loss (term)Damage to the inner ear (cochlea) or nerve pathways; usually not medically or surgically correctable; most common permanent hearing loss (ASHA).

Mixed Hearing Loss (term)Combination of conductive and sensorineural hearing loss (damage in outer/middle ear and inner ear or auditory nerve).

PTA (term)Pure Tone Average measured at specified frequencies (commonly 0.5, 1, 2, and 3 kHz; sometimes 4 kHz or 0.5,1,2,4 kHz).

SSD (term)Single-sided deafness: unilateral profound sensorineural deafness with normal hearing in contralateral ear (normal often defined as PTA air conduction ≤20 dB HL).

Hearing Aids (policy term)

Revision History

2026-06-01material_changeLatest

Removed list of applicable CPT/HCPCS codes for Fitting and Testing of Hearing Aids (92590, 92591, 92592, 92593, 92594, 92595, S0618, V5010, V5011, V5014, V5020, V5264, V5265, V5275).

2026-06-01addedLatest

Added language clarifying medical records documentation used for reviews and that documentation may be required to assess clinical criteria but does not guarantee coverage.

2026-06-01

Policy Summary

PayerUnitedHealthcare

PolicyHearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

Policy CodePolicy CS052KY.12

Change TypeUpdates to documentation language, definitions, code removals, and section updates

Effective DateJun 1, 2026

Next Review Date

Key ActionMaintain complete, legible medical record documentation (history, physical exam, diagnostic test results) to support requested services and make available upon request.

On This Page

{"text":"Documentation of prior non-device management when applicable (medical or surgical interventions)"},

{"text":"Plan of care documenting why the requested device is medically necessary for the member"},

{"text":"InterQual clinical criteria reference: indicate which InterQual CP criterion was used to support medical necessity"},

{"text":"Any state or federal regulatory requirements relevant to coverage (e.g., Kentucky Administrative Regulations)"},

{"text":"Records must be legible and available upon request"},

Maintain complete medical record demonstrating medical necessity and supporting information for reviews or audits

Medical Records Documentation Requirements (Policy Administrative Criteria)

{

"operator":"all","children":[

{"text":"Copy of audiogram(s) with ear-specific thresholds and speech discrimination scores"},

{"text":"Clinical notes documenting symptoms, duration, and prior treatments"},

{"text":"Device-specific eligibility documentation, including manufacturer criteria and age thresholds"},

{"text":"Signed treatment plan or order specifying device type and rationale"},

{"text":"Evidence the provider referred to InterQual clinical criteria for the applicable device or procedure"},

{"text":"Documentation of compliance with state regulatory requirements relevant to coverage decisions (e.g., KAR Title 907, Chapter 001, Regulation 038)"},

{"text":"Operative reports, imaging, or other pertinent test results when applicable"},

Copies of prior authorization requests and determinations, if obtained

]}

Maintain documentation in the member's chart and make available upon request for review or audit; absence of required documentation may result in denial of coverage.

]

}

Documentation Required

Documentation Required for Medical Necessity

Providers must ensure the medical record fully supports medical necessity and that required documentation is legible and available upon request. Reliance on documentation does not guarantee coverage.

Relevant medical history, physical exam, diagnostic test results
Records must be legible and available upon request
Documentation does not guarantee coverage

Sophono Otomag Alpha 1: Partially implanted Sophono Otomag Alpha 1 indications: conductive or mixed hearing loss with PTA bone conduction threshold better than 45 dB HL (0.5,1,2,3 kHz); bilateral fitting applicable for symmetric cases; magnetic implant use for patients ≥5 years.

Refer to FDA clearances for Sophono systems.

Device-specific FDA Indications (Informational coverage prerequisites)

Devices are intended for the following patients and indications per FDA labeling:

Common audiometric conditions described across devices: Conductive or mixed hearing loss who can still benefit from amplification; Single-sided deafness (SSD)/unilateral profound sensorineural deafness with normal hearing in contralateral ear (normal often defined as PTA air conduction ≤20 dB HL); Bilateral fitting when symmetric conductive/mixed hearing loss meets device-specific criteria; Symmetry commonly defined as <10 dB average difference (0.5,1,2,3 kHz) or <15 dB at individual frequencies.

Devices specify PTA bone conduction thresholds (see device-specific thresholds).

Device-specific age and threshold examples: Otomag Alpha 1 Magnetic Implant: patients ≥5 years; PTA bone conduction threshold better than 45 dB HL (0.5,1,2,3 kHz). Cochlear Baha Attract: patients ≥5 years; PTA bone conduction ≤45 dB HL for BP100 processor and ≤55 dB HL for BP1100 processor; SSD indication with hearing ear PTA air conduction ≤20 dB HL. BONEBRIDGE (MED-EL): patients ≥12 years; PTA bone conduction ≤45 dB HL; SSD indication hearing ear PTA air conduction ≤20 dB HL. Osia / Osia 2 Systems: patients ≥12 years; PTA bone conduction ≤55 dB HL; SSD indication hearing ear PTA air conduction ≤20 dB HL. Cochlear Baha 7 Sound Processor: patients of any age may use SoundBand/Softband/SoundArc; implants for patients ≥5 years; PTA bone conduction ≤55 dB HL. Baha BP100: children ≥5 years/adults; PTA bone conduction ≤45 dB HL; SSD hearing ear PTA air conduction ≤20 dB HL. Baha SoundArc and SoundBand/Softband: non-implantable options for patients of any age; thresholds vary by processor (examples: ≤45 dB HL for BP100/Baha4/Baha5; ≤55 dB HL for BP110 Power/Baha5 Power; ≤65 dB HL for Cordelle II/Baha5 SuperPower). ADHEAR system: all ages; PTA bone conduction ≤25 dB HL for conductive loss; SSD with contralateral PTA air conduction ≤20 dB HL. ADHEAR/Softband applications: appropriate for temporary/chronic conductive losses and for children under 5 with softband. Esteem totally implanted middle ear system: FDA approved (PMA). Earlens Contact Hearing Device (2016): patients ≥18 years with mild to severe sensorineural hearing impairment.

Refer to device-specific FDA documents for details.

This policy summarizes coverage scope and clinical evidence for multiple hearing device technologies and explicitly relies on InterQual clinical criteria for medical necessity determinations for wearable hearing aids, bone-anchored/bone conduction devices, and semi-implantable middle ear devices.

Definitions provided include Conductive, Sensorineural, and Mixed hearing loss, and the document notes that FDA device labeling and selection criteria inform device-specific eligibility. Wearable air-conduction hearing aids are identified as proven and medically necessary per InterQual; bone-anchored and semi-implantable devices’ medical necessity is determined using InterQual modules referenced in the policy.

The policy concludes there is insufficient high-quality evidence to support intraoral bone conduction hearing aids, laser/light-based devices (e.g., Earlens), and totally implanted middle ear systems; these are listed as unproven and not medically necessary due to limited study designs, small samples, short follow-up, and lack of high-quality comparative trials. AAO‑HNS position statements and FDA device approvals/cleared indications are cited throughout for informational device-selection thresholds and indications.

Thresholds (policy-extracted examples)

Vibrant Soundbridge pure-tone air conduction thresholds by frequency500 Hz: 30-65 dB; 1,000 Hz: 40-75 dB; 1,500 Hz: 45-80 dB; 2,000 Hz: 45-80 dB; 3,000 Hz: 50-85 dB; 4,000 Hz: 50-85 dB

Vibrant Soundbridge Word Recognition Score>= 50%

BAHA pure-tone threshold for initial indication>= 45 dB (pure-tone threshold hearing loss)

Sophono Otomag Alpha 1 PTA bone conduction thresholdbetter than 45 dB HL (0.5,1,2,3 kHz)

Device-specific PTA bone conduction thresholds (examples)Examples include ≤45 dB HL, ≤55 dB HL, ≤65 dB HL (measured at 0.5,1,2,3 kHz or 0.5,1,2,4 kHz)

PTA air conduction threshold for SSD candidacy (contralateral ear)≤20 dB HL (0.5,1,2,3 kHz)

Symmetry between ears<10 dB average difference (0.5,1,2,3 kHz) or <15 dB at individual frequencies

ECRI (2025) concluded evidence for the Esteem totally implanted middle ear implant is insufficient in quantity and quality, with safety concerns reported and fewer than 300 patients in available studies.

Gurgel et al. (2015) reported subjective benefits in an 81‑participant prospective case series of the SoundBite intraoral BCHA but the study lacked a control group, had short follow-up, and other methodological limitations.

Arbogast et al. (2019) (78 participants) and Gantz et al. (2017) (single‑arm pivotal trial, 43 participants) evaluated the Earlens light‑driven contact hearing aid showing improvements in patient‑reported measures and safety endpoints, but trials were nonblinded, lacked concurrent control groups, and authors recommended comparative studies to establish additional benefit.

Overall the evidence entries cited are single‑arm studies, case series, or limited observational reports that support the policy’s not‑covered/unproven stance for these device categories due to study design limitations and insufficient comparative effectiveness data.

Maintain legible records demonstrating medical necessity
Make records available upon request
Document PTA bone and air conduction thresholds and patient age to match device-specific indications

Devices designed to aid people with hearing impairment; includes semi-implantable electromagnetic and bone-anchored devices classified by the FDA as hearing aids.

Hearing Instruments (regulatory term)Any wearable instrument or device designed for or represented as aiding or improving defective human hearing and any parts, attachments, or accessories (907 KAR 1:038).

Updated definition of 'Conductive Hearing Loss'.

2026-06-01updatedLatest

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information; archived previous policy version CS052KY.11.