CurrentPremera BluecrossPolicy 1.01.528

Hearing Aids (Excludes Implantable Devices)

Defines medical-necessity coverage criteria, documentation requirements, covered and non-covered hearing hardware and accessories for non-implantable hearing aids when a member has a hearing aid benefit; excludes implantable devices and OTC/PSAP devices.

Policy Summary

PayerPremera Bluecross

PolicyHearing Aids (Excludes Implantable Devices)

Policy CodePolicy 1.01.528

Change TypeUpdated (WA mandate, minors criteria, coding)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain and submit medical clearance (minors: otolaryngologist within 6 months or licensed physician showing no change since ENT) or a written prescription (adults) and a complete audiology evaluation within past 6 months with audiometric test data demonstrating need.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria specifically for minors under 18 years of age requiring medical clearance within six months.

Added new CPT codes 92628, 92629, 92631, 92632, 92634, 92635, 92636, 92637, 92638, 92639, 92641, and 92642 effective January 1, 2026.

Updated policy language to align with updated plan language clarifying hearing hardware benefit exclusions (purchases before effective date, post-coverage expenses unless ordered prior, charges in excess of benefit).

Explicitly excluded OTC hearing aids and PSAPs including Hearing Aid Feature software used with compatible Apple AirPods Pro.

Benefit Application updated to reference Washington state mandate requiring coverage every 36 months per ear for hearing instruments for certain fully-insured plans issued/renewed on or after Jan 1, 2026.

1Policy covers non-implantable traditional hearing aids

OTC/PSAP

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OTC and PSAP devices

36 monthsWA mandate replacement frequency per ear

12New CPT codes added effective 2026-01-01

Coverage Summary

Scope: This policy defines medical-necessity coverage criteria, required documentation, covered and non-covered hearing hardware and accessories for non-implantable, prescription traditional hearing aids when a member has a hearing aid benefit. Coverage applies only when a hearing aid benefit exists and is subject to the member contract and applicable laws. (SOURCE: header/effective info and scope)

Coverage stance and subject: The policy covers externally worn, non-implantable hearing aids that meet FDA regulatory requirements and are dispensed as prescription hearing aids; it excludes implantable devices and over-the-counter (OTC) / PSAP devices. Medicare exclusion: hearing aids and examinations for prescribing/fitting are excluded from Medicare coverage per the Medicare Benefit Manual. (SOURCE: chunks 3, 4, 24)

Status and dates: Policy status is CURRENT. Effective date: Feb. 1, 2026 (policy header). Last review: Jan. 12, 2026. Coding updates and historic notes reflect additions effective 01/01/2026. (SOURCE: chunks 0, 31, 6/7/8)

Washington mandate impact: Under Washington law for applicable fully-insured non-grandfathered group plans issued/renewed on or after Jan 1, 2026, carriers must provide coverage for hearing instruments (including bone conduction devices) and must allow replacement every 36 months per ear; carriers may require prior authorization and the mandate does not apply to OTC instruments. Policy Benefit Application incorporates this WA mandate. (SOURCE: chunk 16)

Evidence/regulatory notes: The policy aligns with FDA regulatory distinctions — FDA established an OTC hearing aid category (2022) and issued a De Novo classification (DEN230081, 2024) for Hearing Aid Feature software; the policy explicitly excludes OTC/PSAP devices and references these FDA actions in Evidence. (SOURCE: chunks 25, 28, 4)

Thresholds / Key Facts

Moderate hearing loss threshold40 to 60 dB pure-tone average (bone-conduction detection threshold)

Degree classifications (ASHA PTA)Mild 20-40 dB; Moderate 40-60 dB; Severe 60-80 dB; Profound ≥80 dB

Documentation recency requirementComplete audiology evaluation and prescription/medical clearance within the past 6 months

WA state replacement frequencyCoverage every 36 months per ear for applicable Washington fully-insured plans issued/renewed on/after Jan 1, 2026

Medical Necessity Criteria

General Medical Necessity Criteria

If benefits for a hearing aid are available, coverage requires ALL of the following as applicable:

Medical clearance (minors): For minors under 18 years of age: medical clearance within the preceding six months from an otolaryngologist for an initial evaluation of hearing loss OR from a licensed physician indicating there has not been a substantial change in clinical status since the otolaryngologist evaluation6 months
Required prior to coverage for minors.
Prescription (adults): For non-minors: a written prescription from the examining physician/licensed healthcare provider within the past 6 months6 months
Required documentation.

Not Covered / Exclusions

The Hearing Hardware benefit does not cover the following:

OTC hearing aids and HAF software: Over-the-counter (OTC) FDA-cleared hearing aids available without a prescription or an examination (including Hearing Aid Feature software used with compatible Apple AirPods Pro)
Explicitly non-covered
PSAPs: Over-the-counter hearing assistive devices/personal sound amplification products (PSAPs) (e.g., NewEar, Pocketalker, TV Ears, Cyberscience Amplifier)
Explicitly non-covered
Investigational intraoral bone conduction aids: Non-implantable intraoral bone conduction hearing aids (investigational example: SoundBite Hearing System)
Investigational / not covered

Coding (CPT / HCPCS)

Covered/related CPTCPTCovered

92550	Tympanometry and reflex threshold measurements
92551	Screening test, pure tone, air only
92552	Pure tone audiometry (threshold); air only
92553	Pure tone audiometry (threshold); air and bone
92555	Speech audiometry threshold
92556	Speech audiometry threshold; with speech recognition
92557	Comprehensive audiometry threshold evaluation and speech recognition
92628	Evaluation for hearing aid candidacy; first 30 minutes (effective 01/01/26)
92629	Evaluation for hearing aid candidacy; each additional 15 minutes (effective 01/01/26)
92631	Hearing aid selection services; first 30 minutes (effective 01/01/26)

1–10 of 24

1/3

Covered/related HCPCS (hearing aid devices & supplies)HCPCSCovered

V5008	Hearing screening
V5010	Assessment for hearing aid
V5011	Fitting/orientation/checking of hearing aid
V5014	Repair/modification of a hearing aid
V5020	Conformity evaluation
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

1–10 of 73

1/8

Provider Actions & Billing Guidance

Documentation Required

Medical clearance/prescription and audiology evaluation

Medical clearance is required for minors: obtain documentation within the preceding six months from an otolaryngologist for an initial evaluation of hearing loss or from a licensed physician indicating no substantial change in clinical status since the otolaryngologist evaluation. For adults, include a written prescription from the examining physician/licensed healthcare provider within the past six months. Also include a complete audiology evaluation within the past six months with audiometric test data demonstrating hearing loss and need for a hearing aid.

medical clearance (minors): ENT or licensed physician
prescription (adults): within 6 months
audiometric test data

Prior Authorization

Prior authorization may be required (WA mandate and plan dependent)

A health carrier may require prior authorization or other utilization controls for medically necessary hearing instruments. Check the member contract and plan requirements before ordering and confirm whether the Washington state mandate applies to the member’s fully‑insured plan issued or renewed on or after January 1, 2026.

Background & Evidence

Background: The policy aligns with FDA distinctions between prescription hearing aids and over-the-counter (OTC) hearing aids and clarifies that only FDA-regulated, prescription-dispensed traditional hearing aids are considered under the benefit; OTC and PSAP devices are explicitly not covered. (SOURCE: chunks 4, 22)

Medicare exclusion referenced: The policy cites the Medicare National Coverage rule that hearing aids and examinations for prescribing/fitting are excluded from Medicare coverage. (SOURCE: chunk 24)

Washington state law and effective dates: The policy incorporates Washington’s statutory mandate (RCW 48.43.135 and 2023 c 245 s 1) requiring coverage for hearing instruments for applicable fully-insured group plans issued or renewed on or after Jan 1, 2026, including replacement coverage every 36 months per ear; carriers may require prior authorization. The policy’s Benefit Application and history note the WA mandate and that related changes are effective Jan 1, 2026. (SOURCE: chunk 16, chunk 30)

FDA OTC category and de novo classification in evidence: The source documents FDA actions — the 2022 final rule establishing OTC hearing aids and the 2024 De Novo decision (DEN230081) authorizing Hearing Aid Feature software — and these regulatory updates are cited in the policy Evidence and References. (SOURCE: chunks 25, 28, 14)

Effective/coding notes: The policy history documents edits effective for dates of service on or after Jan 1, 2026 (following provider notification) and adds new CPT codes effective 01/01/2026 for evaluation, selection, fitting, verification and follow-up services; coding changes and historical entries are recorded in the policy history. (SOURCE: chunks 30, 6, 7, 8, 31)

Source	Summary
Medicare coverage exclusion	Hearing aids or examinations for prescribing, fitting, or changing hearing aids are excluded from Medicare coverage (Medicare Policy Benefit Manual Chapter 16).
FDA regulatory updates	FDA established an OTC hearing aid category (final rule effective Oct 17, 2022) and issued a De Novo classification (DEN230081, Sept 12, 2024) for Hearing Aid Feature software as an OTC, self‑fitting air‑conduction hearing aid software.

Definitions

Term	Definition
Traditional hearing aid	A non‑implanted, non‑disposable on‑ear or in‑ear device that is FDA‑regulated and dispensed only by prescription.
Pure‑tone average (PTA)	Average air‑conduction threshold for 1000, 2000 and 3000 Hz measured with an earphone; used to classify degree of hearing loss.
Conductive hearing loss	Hearing loss due to ineffective conduction through the outer/middle ear; may be correctable medically or surgically.
Sensorineural hearing loss	Hearing loss due to damage to inner ear hair cells or auditory nerve; usually permanent.

Medicare Determinations

Name	Type	Effective Date	Number/Notes
Hearing Aids Exclusion	NCD	2005-11-10	Medicare national coverage determination: hearing aids or examinations for prescribing/fitting are excluded from coverage (Medicare Policy Benefit Manual Chapter 16).

Revision History

2025-10-01 (effective for dates of service on or after January 1, 2026)addition

Added coverage criteria for minors under 18 years of age requiring medical clearance within the preceding six months (effective for dates of service on or after January 1, 2026, following 90-day provider notification). Marked material.

2026-01-01coding update

Coding update: added new CPT codes effective January 1, 2026 — 92628, 92629, 92631, 92632, 92634, 92635, 92636, 92637, 92638, 92639, 92641, and 92642.

2026-02-01clarification

Policy Summary

PayerPremera Bluecross

PolicyHearing Aids (Excludes Implantable Devices)

Policy CodePolicy 1.01.528

Change TypeUpdated (WA mandate, minors criteria, coding)

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Audiology evaluation: A complete audiology evaluation within the past 6 months6 months

Includes audiometric test data/results demonstrating hearing loss and need for a hearing aid.

Degree of hearing loss: Hearing loss that is moderate (40 to 60 dB PTA bone-conduction detection threshold) or greater40 to 60 dB PTA (bone-conduction)

Policy threshold for medical necessity.

FDA/prescription requirement: Hearing aids must meet FDA regulatory requirements and be dispensed as prescription hearing aids

OTC and PSAP devices are excluded.

Selection, fitting, follow-up: Selection and fitting based on complete work-up by a hearing professional including skilled hearing tests, assessment, fitting and follow-upFollow-up within 30 days after delivery

Includes follow-up consultation within 30 days following delivery.

Recommendation and history: Recommendation for the type of hearing aid technology appropriate for the member and history of prior/current use of hearing aid (unless never had one)

Part of required documentation.

Covered Hearing Hardware and Services (under Hearing Care benefit)

Benefits provided when eligibility/met and hearing hardware benefit applies:

Covered Hearing Hardware and Services

Hearing aids (monaural or binaural) prescribed as a result of an exam
Ear molds as necessary to maintain optimal fit
Bone conduction devices: The hearing aid instruments, including bone conduction hearing devices
Rental during repair: Hearing aid rental while the primary unit is being repaired
Initial batteries/ancillary: The initial batteries, cords, and other necessary ancillary equipment (when obtained upon purchase)
Initial batteries supplied when obtained upon purchase.
Warranty: A warranty, when provided by the manufacturer
Follow-up consultation: A follow-up consultation within 30 days following delivery of the hearing aids with either the prescribing physician or audiologist30 days
Services: Auditory training, fitting (including adjustment), repairs, servicing, and alteration of hearing aid equipment purchased under this benefit

Pre-effective date purchases: Hearing aids purchased before the effective date of coverage under the member's plan

Not covered

Batteries/ancillary not at purchase: Batteries or other ancillary equipment except that obtained upon purchase of the hearing aids

Not covered routinely

Post-coverage expenses: Expenses incurred after coverage under the plan ends unless ordered before coverage end and delivered within 90 days after coverage endDelivery within 90 days after coverage end if ordered before end

Not covered

Charges in excess of this benefit; these are not eligible for coverage under other benefits

Not covered

Implantable devices: Cochlear implants and other implantable devices (see related implantable device policies)

Excluded from this benefit

Telephone adapters

Not covered

Applies to fully‑insured WA plans issued/renewed on or after 2026-01-01

Documentation Required

Fitting and follow-up documentation

Document the selection and fitting process, the recommendation for the type of hearing aid technology appropriate for the member, and the trial/follow‑up plan. Include a follow‑up consultation within 30 days after delivery and record history of prior or current hearing aid use when applicable.

History of prior hearing aid use requirement

Billing Rule

Use specified CPT/HCPCS codes for services and devices

Report the appropriate CPT codes for evaluation, selection, fitting, verification, and post‑fitting follow‑up services and report HCPCS V‑codes for devices and supplies as listed in the policy. Use the new CPT codes effective 01/01/2026 where applicable.

CPT codes: 92628, 92629, 92631, 92632, 92634, 92635, 92636, 92637, 92638, 92639, 92641, 92642
HCPCS device/supply codes: V50xx‑V52xx range (see policy V‑codes list)
Effective date for new CPT codes: 01/01/2026

Denial Risk

Denial risk for OTC/PSAP devices and pre-coverage purchases

Claims for over‑the‑counter (OTC) hearing aids or personal sound amplification products (PSAPs), investigational devices (e.g., non‑implantable intraoral bone conduction aids), devices purchased before the plan’s coverage effective date, and items outside the hearing hardware benefit limits are at risk for denial.

OTC hearing aids and PSAPs (not covered)
Investigational intraoral bone conduction devices (e.g., SoundBite)
Hearing aids purchased before the plan’s coverage effective date
Expenses after coverage ends unless ordered before and delivered within 90 days
Charges in excess of the benefit or items outside benefit limits

Clarifying edits to align guideline language with updated plan language about hearing hardware benefit exclusions (hearing aids purchased before the plan effective date, expenses after coverage end unless ordered prior and delivered within 90 days, charges in excess of benefit); intent unchanged.

2025-02-01 (policy note added in 2025; retained thereafter)addition

Explicitly excluded OTC hearing aids and PSAPs, including Hearing Aid Feature software used with compatible Apple AirPods Pro. Marked material.

2026-01-01 (statutory effective date)benefit application updateLatest

Washington state mandate referenced in Benefit Application: for non-grandfathered fully‑insured group plans issued/renewed on or after January 1, 2026, carriers must cover hearing instruments every 36 months per ear (does not include OTC instruments); carriers may require prior authorization. Marked material.