DraftPremera BluecrossPolicy N/A

Hearing Aids (Excludes Implantable Devices)

Defines medical necessity, coverage, documentation, coding, and exclusions for non‑implantable hearing aids under the hearing care benefit for Premera Blue Cross members; applies where a hearing aid benefit exists and is subject to member contract and applicable laws.

Policy Summary

PayerPremera Bluecross

PolicyHearing Aids (Excludes Implantable Devices)

Policy CodePolicy N/A

Change TypeCoverage clarifications and exclusions added

Effective DateJan: 1, 2026* 9, 2025 NZA

Next Review DateN/A

Key ActionObtain and document medical clearance from an otolaryngologist within 6 months for minors and ensure prescription-dispensed hearing aids meet FDA regulatory requirements.

SourceLink

POLICY UPDATE CHANGES

Added that over-the-counter, FDA cleared hearing aids available without a prescription or an examination by a hearing professional are not covered, including the Hearing Aid Feature software used with compatible Apple AirPods Pro.

Coverage criteria for minors under 18 years of age were added, effective for dates of service on or after January 1, 2026.

Corrected policy wording to require hearing aids that meet FDA regulatory requirements and are dispensed as prescription hearing aids (changed from 'FDA-approved').

Added coverage clarification that over-the-counter FDA-cleared hearing aids are not covered, and specifically excluded Hearing Aid Feature software authorized by FDA De Novo.

36replacement frequency (months)

40–60PTA range (dB)

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Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met:

General conditions: Member has a hearing aid benefit under their contract; the hearing aid meets FDA regulatory requirements and is dispensed as a prescription hearing aid; a complete audiology evaluation and documentation within the past 6 months demonstrate the member's hearing loss and need for a hearing aid; the selected device meets the member's hearing requirements in the environments and conditions where enhanced hearing is needed.

See documentation requirements for specifics (prescription, audiometry, test data, history, recommendation, follow-up plan).

Degree of hearing loss: Moderate hearing loss is defined as a pure tone average (PTA) bone-conduction detection threshold of 40–60 dB; hearing aids may be considered medically necessary for conductive, sensorineural, or mixed loss within this PTA range when criteria are met.PTA 40–60 dB

Applies to conductive, sensorineural, or mixed hearing loss.

Pediatric requirement: For minors under 18 years of age, medical clearance within the preceding 6 months from an otolaryngologist is required for an initial evaluation of hearing loss; a licensed physician may provide clearance only if documentation indicates there has been no substantial change in clinical status since the otolaryngologist's initial evaluation.6 months

Requirement reflects state mandate and policy updates effective January 1, 2026 where applicable.

Prescription hearing aids (covered with criteria)

Covered when ALL of the following are met for prescription-dispensed devices:

Prescription hearing aids coverage: Hearing aids that meet FDA regulatory requirements and are dispensed as prescription hearing aids may be considered medically necessary when the policy's medical necessity criteria (including documentation and audiometric thresholds) are met.

Providers should document that devices were dispensed as prescription hearing aids and meet FDA regulatory requirements; prior authorization may be required per applicable mandates.

Over-the-counter hearing aids and self-fitting software (not covered)

Not covered when ANY of the following apply:

OTC and software exclusions: Over-the-counter, FDA-cleared hearing aids available without a prescription or an examination by a hearing professional are not covered; this includes software-classified self-fitting products such as the Hearing Aid Feature (HAF) software authorized by FDA De Novo and other self-fitting software intended for individuals 18 years or older.

Applies to devices intended for individuals ≥ 18 years as specified by FDA OTC and De Novo classifications; claims billed as covered hearing hardware or professional-dispensed hearing aids will be denied when they meet these exclusion criteria.

Over-the-counter hearing assistive devices and personal sound amplification products (PSAPs) that are available without a prescription are explicitly not covered under the Hearing Hardware benefit. Examples include consumer amplifiers such as Pocketalker, TV Ears, NewEar, and similar devices. Investigational hearing devices (for example, non‑implantable intraoral bone conduction systems) are also classified as investigational and are not covered.

Over-the-counter, FDA‑cleared hearing aids that are available without a prescription or an examination by a hearing professional are not covered. This exclusion specifically includes self‑fit software examples provided in the document (e.g., Hearing Aid Feature software used with compatible Apple AirPods Pro).

Medicare excludes coverage for hearing aids and for examinations performed for the purpose of prescribing or changing hearing aids. Claims submitted to Medicare for these items or services are therefore not covered under Medicare national policy.

Additional clarifications: OTC hearing aids and PSAPs that can be obtained without a prescription are non‑covered. Devices identified as investigational in the policy (for example, certain non‑implantable intraoral bone conduction systems) are considered investigational and are not medically necessary; claims for these devices will be denied.

If an OTC device or self‑fitting software is billed as covered hearing hardware or as a professionally dispensed prescription hearing aid, it will be treated as misclassified/noncovered and claims will be denied. Providers should ensure billing reflects the actual nature of the product and the dispensing pathway required for covered prescription hearing aids.

Billing Codes and Coding Guidance

Covered CPT CodesCPTCovered

92550	Tympanometry and reflex threshold measurements.
92551
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.
0208T	Pure tone audiometry (threshold), automated; air only.
0209T	Pure tone audiometry (threshold), automated; air and bone.
0210T	Speech audiometry threshold, automated.
0211T	Speech audiometry threshold, automated; with speech recognition.

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Covered HCPCS CodesHCPCSCovered

V5014	Repair/modification of a hearing aid.
V5030	Hearing aid, monaural, body worn, air conduction.
V5040	Hearing aid, monaural, body worn, bone conduction.
V5120-V5267	Hearing aids, services and accessories.
V5298	Hearing aid, not otherwise classified.

Covered CPT Codesmixed

No codes listed

Medicare exclusionsmixedNot Covered

No codes listed

Moderate hearing loss PTA threshold

PTA range40 to 60 dB (pure‑tone average)

Measurement basisBased on pure‑tone average bone‑conduction detection threshold (policy specifies PTA used for defining moderate loss)

Clinical applicationUsed to define moderate hearing loss qualifying for medically necessary prescription hearing aids

Age for OTC devices

Minimum age>= 18 years

Regulatory contextFDA final rule (Oct 2022) established OTC hearing aids for individuals 18 years and older

Provider Responsibilities, Documentation, and Billing Risks

Prior Authorization

Prior Authorization / Provider Action

Prior authorization may be required for medically necessary hearing instruments per plan or state mandate. Providers should verify benefit coverage and submit any required prior authorization before dispensing to avoid claim denials or delays.

Verify member benefit (fully-insured vs self-funded) and plan effective dates
Obtain prior authorization when required by the carrier or member contract

Billing Rule

Prescription Hearing Aids — Dispensing & Documentation

Prescription hearing aids must be dispensed and documented as prescription devices. Claims for over-the-counter (OTC) hearing aids or PSAPs are excluded and may be denied. Document FDA-regulatory status of the device and that the device was prescribed following an exam.

Background and Context

Hearing aids are external amplification devices intended to improve hearing for individuals with conductive, sensorineural, or mixed hearing loss. Candidates for prescription, FDA‑regulated hearing aids typically include individuals with clinically significant hearing loss (policy recognizes moderate hearing loss as a common threshold for coverage, defined by a pure‑tone average of 40 to 60 dB). Pediatric candidates (under 18) have additional requirements under the policy and applicable mandates, including recent medical clearance prior to coverage.

Definitions

Pure-tone average (PTA) definition

DefinitionPure‑tone average (PTA) = the average of an individual's hearing thresholds at specified frequencies in each ear

Frequencies used (ASHA)Average of air‑conduction thresholds at 1000, 2000, and 3000 Hz

UsePTA is used to classify degree of hearing loss (e.g., mild, moderate, severe, profound)

Sensorineural, Conductive, Mixed hearing loss definitions

Sensorineural hearing lossDamage to inner‑ear hair cells (cochlea) or auditory nerve; typically permanent and not correctable medically/surgically.

Conductive hearing lossImpaired conduction of sound through outer or middle ear (e.g., blockage/damage/disease); may be responsive to medical or surgical intervention.

Policy Revision History

2025-10-01interim_reviewLatest

Interim review approved Sep 9, 2025; added coverage criteria for minors under 18 effective for dates of service on or after 2026-01-01 following 90-day provider notification.

2025-02-01annual_review

Policy reviewed and references updated; clarified that over-the-counter, FDA-cleared hearing aids (including Hearing Aid Feature software for Apple AirPods Pro) are not covered.

2024-03-01

Policy Summary

PayerPremera Bluecross

PolicyHearing Aids (Excludes Implantable Devices)

Policy CodePolicy N/A

Change TypeCoverage clarifications and exclusions added

Effective DateJan: 1, 2026* 9, 2025 NZA

Next Review DateN/A

Key ActionObtain and document medical clearance from an otolaryngologist within 6 months for minors and ensure prescription-dispensed hearing aids meet FDA regulatory requirements.

SourceLink

On This Page

Documentation Required

Required Documentation

Required documentation must include: a recent audiology evaluation and explanation of audiometric test data demonstrating need, a written prescription from the examining licensed provider within 6 months, and a follow-up plan. For minors (<18 years) include medical clearance from an otolaryngologist within the preceding 6 months for initial evaluation, or from a licensed physician if clinical status unchanged.

Include complete audiology evaluation within past 6 months
Include written prescription from examining physician/licensed provider within 6 months
For minors, include otolaryngologist medical clearance (initial) or licensed physician clearance if no substantial clinical change
Document history of prior hearing aid use or note if never used
Provide recommendation for appropriate hearing aid technology and follow-up/trial plan

Denial Risk

Noncovered Devices and Denial Risk

Claims for OTC hearing assistive devices and PSAPs are excluded and present a denial risk if billed under the hearing hardware benefit. Devices not covered or considered investigational (e.g., non-implantable intraoral bone conduction devices such as SoundBite) may be denied.

Do not bill OTC or PSAP devices under the hearing aid benefit (examples: Cyberscience Amplifier, NewEar, Pocketalker, TV Ears)
Be aware that certain devices may be classified investigational and denied (e.g., SoundBite)

Hearing Aid Feature (HAF) software definition

DefinitionHearing Aid Feature (HAF) = a software‑only mobile medical application intended to amplify sound for individuals 18 years or older using compatible wearable electronics via a self‑fitting strategy (FDA De Novo DEN 230081)

IndicationIntended for perceived mild to moderate hearing impairment and adjusted by the user without a hearing professional

Coverage implicationHAF software authorized by FDA De Novo is explicitly excluded from coverage when billed as covered hearing hardware or professional‑dispensed devices