CurrentAlliance HealthPolicy 13 B

Soft Band and Implantable Bone Conduction Hearing Aid External Parts Replacement and Repair

NC Medicaid policy governing coverage, prior approval, and documentation requirements for new soft band bone conduction hearing aids and replacement/repair of external parts for soft band and implantable bone conduction hearing aids; applies to enrolled NC Medicaid beneficiaries and providers billing Medicaid.

Policy Summary

PayerAlliance Health

PolicySoft Band and Implantable Bone Conduction Hearing Aid External Parts Replacement and Repair

Policy CodePolicy 13 B

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior approval requests electronically via NCTracks with required documentation for all new soft band devices and out-of-warranty replacement sound processors.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Under 21EPSDT applies

RequiredPrior approval

Apr 1, 2023Amended date

40-50 dBPTA eligibility

≥60%Speech discrimination

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5 yrsReplacement expectancy

Coverage Criteria

New Soft Band Bone Conduction Hearing Aid

Covered when ALL of the following are met

General medical necessity: Procedure, product, or service is individualized, specific, consistent with symptoms or confirmed diagnosis, not in excess of beneficiary's needs; can be safely furnished; no equally effective and more conservative or less costly treatment available statewide; not primarily for convenience.

Based on General Criteria Covered

Age and candidacy for soft band device: Beneficiary is a candidate for bone conduction hearing aid implant surgery and has not reached the age of 5 years OR is under 21 years of age and is not an appropriate surgical candidate.age <5 OR age <21 and not surgical candidate

From New Soft Band Bone Conduction Hearing Aid criteria

Hearing loss severity and prior device failure: Beneficiary has moderate to severe, bilateral, conductive or mixed hearing loss that cannot be effectively restored by conventional air conduction hearing aids or a conventional bone conduction hearing aid.moderate to severe bilateral conductive or mixed hearing loss

From New Soft Band Bone Conduction Hearing Aid criteria

Specific ear conditions: Beneficiary meets at least one condition from Clinical Coverage Policy 1A-36: congenital or acquired abnormalities of middle or external ear canal preventing air conduction aid use; tumors of external canal or tympanic cavity; dermatitis of external ear canal; chronic external otitis or otitis media with persistent discharge.

Cross-reference to Policy 1A-36

Replacement and Repair of External Parts

Covered when replacement or repair is medically necessary

External parts replacement/repair: Replacement and repair of components of soft band and implantable bone conduction hearing aids are covered when necessary to maintain the device's ability to analyze and code sound, providing awareness and identification of sounds and facilitating communication.

From Description of the Procedure

New soft band bone conduction hearing aid

Covered when ALL of the following are met

Population and candidacy: Beneficiary is a candidate for bone conduction hearing aid implant surgery and is under 5 years of age, or is under 21 years of age and not an appropriate surgical candidate; has moderate to severe bilateral conductive or mixed hearing loss not effectively restored by conventional air or bone conduction aids.

From New soft band bone conduction hearing aid criteria

Anatomic/clinical indications (one required): One or more of: congenital or acquired abnormalities of the middle or external ear canal precluding air conduction aid; tumor of external canal or tympanic cavity; dermatitis of external ear canal; chronic external otitis or otitis media with persistent discharge.

From New soft band bone conduction hearing aid criteria

Audiometric criteria: Bone conduction pure-tone average 40–50 dB with no single frequency poorer than 50 dB (at 1000 and 2000 Hz) AND speech discrimination of the indicated ear ≥60% on CNC testing at elevated SPL when testable.PTA 40-50 dB; speech discrimination ≥60%

External parts replacement and repair — out of warranty

Covered when ALL of the following are met

Eligibility and device status: Beneficiary is approved for and currently wearing a soft band device prior to turning 21 or is ≥5 years and implanted; device (soft band or implantable) is FDA-approved and meets coverage standards under Clinical Coverage Policy 1A-36; device is in continuous use and still meets beneficiary needs.

From External Parts Replacement and Repair criteria

Need and documentation: Replacement or repair is necessary to allow the device to be functional; treating audiologist has obtained medical clearance from an otolaryngologist or has a physician's prescription with implant/system and surgery date(s); treating audiologist has documentation that substantiates the need for the replacement or repair of part(s); component/service furnished at a safe, efficacious, and cost-effective level.

From External Parts Replacement and Repair criteria

Prior approval requirement: All replacement sound processors, except those covered under warranty, require prior approval.

From External Parts Replacement and Repair criteria

Sound processor upgrades

Covered when ALL of the following are met

Upgrade indication: Beneficiary response to existing sound processor is inadequate to the point of interfering with activities of daily living OR the sound processor is no longer functional and cannot be replaced with the same model.

From Sound Processor Upgrades criteria

Additional coverage criteria for upgrade: Beneficiary is approved for and currently wearing a soft band device prior to turning 21 or is ≥5 years and implanted; the upgrade is FDA-approved and meets standards under Clinical Coverage Policy 1A-36; device is in continuous use and still meets beneficiary needs; treating audiologist has obtained medical clearance from an otolaryngologist or has a physician's prescription with implant/system and surgery date(s); treating audiologist has documentation that substantiates medical necessity for the upgrade; component/service furnished at a safe, efficacious, and cost-effective level.

From Sound Processor Upgrades criteria

Cosmetic exclusions: Upgrades solely to achieve aesthetic improvement are not medically necessary and will not be covered.

From Sound Processor Upgrades criteria

Medical necessity and replacement/upgrade criteria

Coverage and upgrades/replacements are allowed when documentation on file meets all requirements

Documentation requirements for new soft band device: Maintain a signed treating audiologist letter that includes audiologist contact information and beneficiary identification; verification the soft band device is FDA-approved and currently functional; specific medical necessity; medical clearance from an otolaryngologist; comprehensive audiology report (audiogram, sound field audiogram, speech perception, sound and speech awareness tests); documentation regarding future implant surgery or ineligibility for implant; and documentation that conventional aids cannot effectively restore hearing.

Refer to Subsection 3.2.1 for beneficiary-specific criteria

Documentation for external parts replacement/repair (out of warranty): Keep a signed audiologist letter (including original surgery dates if implanted), verification of FDA approval and functional use, and specific information about repair/replacement parts and quantities; for soft band devices include medical clearance from an otolaryngologist or for implantable systems a physician's signed prescription with implanted system and surgery date(s).

From Audiologist's Letter and Additional Documentation sections

Sound processor upgrade when current processor is functional:

Services, products, or procedures that are unsafe, ineffective, experimental or investigational, or not medical in nature are excluded from coverage under the EPSDT special provision. For beneficiaries under age 21, EPSDT requires coverage of medically necessary services to correct or ameliorate a condition identified through screening, but it does not mandate coverage for items that meet any of these exclusion criteria.

Requests for replacement or repair that are intended for spare or back-up emergency equipment are not covered. Similarly, requests for a soft band bone conduction hearing aid to treat unilateral sensorineural hearing loss (single-sided deafness), services for residents of nursing facilities, or components/services already covered by another agency are excluded under this policy.

When replacement or repair is covered under a manufacturer's warranty, Medicaid will not be charged. No charge to Medicaid is allowed for warranty-covered repairs or replacements, pickup or delivery, or the assembly of Medicaid-reimbursed parts — such items must be handled through the warranty process.

If a third-party payer (for example, Medicare or private insurance) has legal liability for an item or service, providers must bill that third party before submitting a claim to Medicaid. Providers are required to take reasonable measures to determine third-party liability and bill the responsible payer prior to billing Medicaid.

Any service, product, or procedure that is unsafe, ineffective, experimental or investigational, or not generally recognized as accepted medical practice is not covered under this policy. This exclusion applies regardless of beneficiary age and is consistent with the EPSDT limitations described in the policy.

Upgrading an existing, functioning, and replaceable sound processor solely for cosmetic or aesthetic reasons is not medically necessary and will not be covered. The policy explicitly states that upgrades for aesthetic improvement are excluded from coverage.

If the current sound processor is still functional or can be replaced with the same model, an upgrade is not supported unless the provider supplies additional documentation demonstrating inadequate performance. Required evidence includes aided testing that shows the beneficiary's response is inadequate to the point of interfering with activities of daily living (for example, aided sound field audiogram, aided speech perception, aided sound awareness, and aided speech awareness tests).

Coding

Claims-Related Codes (see Attachment A)mixed

No codes listed

Covered HCPCS Codes (replacement/repair external parts)HCPCSCovered

L8691	Replacement external sound processor for auditory osseointegrated device; Lifetime Expectancy: Once every 5 years
L8692	Replacement body worn (headband or other means of external attachment) external sound processor for auditory osseointegrated device used without osseointegration; Lifetime Expectancy: Once every 5 years
L8621	Replacement zinc air battery for use with cochlear implant device, each; Lifetime Expectancy: N/A
L7510	Repair or replacement of minor prosthetic device parts; Lifetime Expectancy: As necessary; requires invoice

Age criteria for soft band vs implant

Age-based candidacySoft band indicated for beneficiaries who are candidates for bone conduction implant surgery and have not reached age 5; alternatively, soft band may be used for beneficiaries under 21 who are not appropriate surgical candidates.

EPSDT considerationBeneficiaries under 21 may qualify under EPSDT but prior approval requirements still apply.

Implant pathwayBeneficiaries age ≥5 who are appropriate surgical candidates should be evaluated for implantable bone conduction devices per Policy 1A-36.

Bone conduction pure-tone average

Required PTABone conduction pure-tone average (PTA) 40–50 dB with no single frequency poorer than 50 dB at 1000 and 2000 Hz.

Testing frequencies specified

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior approval is required for all new soft band bone conduction hearing aids and for replacement and repair of sound processors that are not covered under warranty. Providers must obtain prior approval electronically through NCTracks and ensure all required documentation is submitted; failure to obtain prior approval may result in denial and providers who deliver items requiring prior approval before approval is received do so at their own risk.

Prior approval required for all new soft band bone conduction hearing aids (see Subsection 5.1 and 3.2.2).
Prior approval required for replacement sound processors that are out of warranty or are upgrades (Subsections 5.1.2 and 5.1.3).
Identical replacement sound processors under warranty do not require prior approval (Subsection 5.1.4).
Submit prior approval requests electronically at http://www.nctracks.nc.gov (Attachment C, Subsection 5.1).
Providers who deliver items before prior approval are received assume financial risk (Subsection 5.7).

Background

Replacement and repair of external components for soft band and implantable bone conduction hearing aids are intended to maintain device function for sound analysis and identification and to facilitate communication. Coverage is allowed when the device is FDA-approved, the beneficiary meets clinical and audiometric criteria, and required documentation (including medical clearance and audiologist substantiation of medical necessity) is on file. Items or services that are explicitly excluded — such as spare/back-up equipment, requests for unilateral sensorineural hearing loss, warranty-covered repairs, or services that are unsafe or experimental — remain noncovered even when replacement or repair would otherwise restore function.

Definitions

DefinitionsNone Apply.

Usage noteNo additional policy-specific definitions are provided in this section.

ReferenceSee Section 1.1 of the policy for formal definitions statement.

Soft band bone conduction hearing aid

Device descriptionAn external sound processor used without osseointegration (soft band device without surgically implanted components).

Indication contextUsed for beneficiaries who are candidates for implant surgery but are under age thresholds or are not appropriate surgical candidates.

Regulatory requirement

Policy Summary

PayerAlliance Health

PolicySoft Band and Implantable Bone Conduction Hearing Aid External Parts Replacement and Repair

Policy CodePolicy 13 B

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior approval requests electronically via NCTracks with required documentation for all new soft band devices and out-of-warranty replacement sound processors.

SourceLink

On This Page

From Audiometric criteria

Device and documentation criteria: Requested soft band device is FDA-approved; treating audiologist has obtained medical clearance from an otolaryngologist; treating audiologist has documentation that substantiates the need; component/service furnished at a safe, efficacious, and cost-effective level.

From New soft band bone conduction hearing aid criteria

If current sound processor is functional or replaceable with the same model, provide additional documentation showing inadequate response interfering with activities of daily living including aided sound field audiogram, aided speech perception test, aided sound awareness test, and aided speech awareness test.

From Additional Documentation for Sound Processor Upgrade

Threshold requirement explicitly applies to 1000 Hz and 2000 Hz.

ContextPTA criterion is part of audiometric eligibility for new soft band devices when conventional aids cannot effectively restore hearing.

Speech discrimination

Speech discrimination thresholdSpeech discrimination ≥60% on CNC words at elevated SPL when testable.

Exception for young childrenIf beneficiary is too young to perform speech discrimination testing, the CNC criterion may not be testable.

Documentation requirementAudiology report and speech perception tests must be retained in the beneficiary file.

Replacement sound processor lifetime expectancy

Replacement intervalReplacement external sound processors (L8691, L8692) — lifetime expectancy: once every 5 years.

Applicable codesL8691 (external sound processor for osseointegrated device) and L8692 (body-worn/headband external sound processor used without osseointegration) share the 5‑year expectancy.

Claims guidanceReport the most specific HCPCS code that describes the replacement sound processor; follow invoicing and prior‑approval rules as applicable.

Documentation Required

Eligibility Verification and EPSDT

Providers must verify Medicaid beneficiary eligibility at each service encounter and maintain required medical record documentation. Eligibility verification does not remove prior approval requirements, including for beneficiaries covered under EPSDT.

Verify beneficiary Medicaid eligibility each time a service is rendered (Chunk 11).
EPSDT does not eliminate prior approval requirements for services that require prior approval; beneficiaries under 21 still need prior approval (Chunk 15).
Include only dates of service when recipient is eligible for Medicaid on claims (Chunk 69).

Documentation Required

Required Documentation for Prior Approval and Medical Records

Prior approval requests must include specific required documentation. Providers must also retain detailed medical record documentation related to the service, repair, or replacement.

For new soft band devices submit: medical clearance from an otolaryngologist, a letter of medical necessity from the treating audiologist, an audiology report (audiogram, evaluation, speech and sound tests), history of hearing aid use, future surgery information, and documentation that conventional air or bone conduction hearing aids cannot effectively restore hearing (Subsection 5.1.1).
For out-of-warranty identical replacements submit: medical clearance or the prescribing physician's original prescription with surgery information and a letter of medical necessity from the treating audiologist (Subsection 5.1.2).
For upgrades submit: documentation the current processor is nonfunctional or inadequate for activities of daily living, medical clearance/prescription, letter of medical necessity, and treating audiologist's documentation supporting the upgrade (Subsection 5.1.3 and 5.5.3).
Required audiologist letter contents: audiologist name/business/address/phone, beneficiary name and Medicaid ID, verification the device is FDA approved and in functional use, original surgery dates if implanted (when applicable), and specific medical necessity details (Subsections 5.3.1, 5.4.1, 5.5.1).
Additional audiology documentation: audiology report including sound field audiogram, speech perception and awareness tests, history of hearing aid use, documentation regarding future surgery or inappropriateness for implant, and confirmation that hearing loss cannot be effectively restored by conventional aids (Subsection 5.3.2 and 5.4).
Submit prior approval requests and attach documentation electronically via NCTracks; attachments may also be faxed to ATTN: AI Parts when allowed (Chunks 71-73).
Maintain medical records: copy of medical clearance or physician prescription with surgery dates, signed audiologist letter, all tests/evaluations, full description of items supplied, dates and shipping, details of services/repairs including parts and labor, warranty information; retain records through life of implant or minimum five years (ten years for soft band devices) and furnish upon request (Chunk 52).

Documentation Required

Conservative Therapy Consideration

Providers must document that less invasive or more conservative treatments are not equally effective before requesting coverage for a soft band or implantable bone conduction hearing aid or replacement/upgrade.

Medicaid covers services only when no equally effective and more conservative or less costly treatment is available statewide (General Criteria, Chunk 17).
For new soft band devices, documentation must show that conventional air conduction or conventional bone conduction hearing aids cannot effectively restore hearing (Subsection 3.2.2 and Subsection 5.1.1).
Beneficiary must meet audiometric thresholds and speech discrimination criteria as detailed in Subsection 3.2.2 for coverage consideration.

Billing Rule

Invoice Requirement for L7510

Claims for miscellaneous item code L7510 require a supporting invoice listing each manufacturer's item number and the total invoice cost for the miscellaneous items billed; L7510 does not require prior approval but documentation is required on the claim.

If multiple miscellaneous items are provided on the same day, bill L7510 on one line with one unit and the total invoice cost (Chunk 69).
Include an invoice with the manufacturer's item number for each miscellaneous item when billing L7510; claims for L7510 do not require prior approval (Chunk 69).

Billing Rule

Third-Party Billing and Acceptance of Medicaid Payment

Providers must pursue other sources of payment (third-party liability) before billing Medicaid and must accept Medicaid payment as payment in full.

Take reasonable measures to identify third-party payers (Medicare, private insurance) and bill them before Medicaid (10A NCAC 22J.0106) (Chunk 54).
Refer to NCTracks Provider Claims and Billing Assistance Guide for Medicare crossover and third-party billing instructions (Chunk 54).
Providers shall accept Medicaid payment as payment in full and not balance-bill (10A NCAC 22J.0106) (Chunk 55).

Requested soft band devices must be FDA‑approved per device/documentation criteria.

Medical clearance / Physician prescription

Medical clearance requiredMedical clearance from an otolaryngologist is required for soft band devices and must be kept on file.

Physician prescription for implantsFor implantable systems, a physician's signed prescription with implanted system and original surgery date(s) must be on file.

Audiologist documentationTreating audiologist must provide a signed letter and audiology report supporting medical necessity and device use.