ModifiedColorado Rocky Mountain Health PlansPolicy CS052.V

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

Policy governing coverage and medical necessity of wearable, bone-anchored, semi-implantable, and related hearing devices for Colorado Rocky Mountain Health Plans members (with state-specific exceptions called out). Applies to evaluation, implantation, replacement, and upgrades of hearing devices.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS052.V

Change TypeDefinition updatecode list removalcontent updates

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and document device-specific FDA audiometric selection criteria and prior trial use when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated definition of 'Conductive Hearing Loss'.

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

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.

5proven device types

3unproven device types

20+chunks in extract

Multiple

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

5.2%/13.1%reported complication rates

1policy history entries

Coverage and Medical Necessity Criteria

Covered / Medically Necessary Devices

Covered when used according to FDA-labeled indications for individuals who are not candidates for air conduction hearing aids:

Proven and medically necessary devices (select any applicable): Bilateral fully or partially implantable bone-anchored Hearing Aids for Conductive or Mixed Hearing Loss in both ears; Bilateral or unilateral bone conduction Hearing Aids using a headband or adhesive (without osseointegration); Semi-implantable electromagnetic Hearing Aid for Sensorineural Hearing Loss; Unilateral fully or partially implantable bone-anchored Hearing Aids for Conductive or Mixed Hearing Loss in one or both ears; Unilateral fully or partially implantable bone-anchored Hearing Aids for Sensorineural Hearing Loss in one ear.

Devices must be used according to FDA-labeled indications, contraindications, warnings, and precautions.

Standard treatment: Wearable air-conduction Hearing Aids required for the correction of a Hearing Impairment are proven and medically necessary and are the standard treatment when they can correct the impairment.

ACHAs should be used when they can correct the impairment before considering implantable or bone-conduction alternatives.

Not Medically Necessary / Experimental Devices

Devices identified as unproven and not medically necessary due to insufficient evidence:

Not medically necessary / unproven: Intraoral bone conduction Hearing Aids; Laser or light-based Hearing Aids; Totally implanted middle-ear hearing systems.

These device types are considered unproven for treating hearing loss due to insufficient evidence of efficacy.

Equipment Upgrades

Equipment upgrades

Upgrades treated as new service: A change in the member's medical condition and equipment needs requires the same criteria as a new request; equipment upgrades are equivalent to a new service.

Apply the same medical necessity criteria and documentation requirements as for initial or replacement devices.

Coverage criteria and clinical considerations

Evidence-supported coverage rationale and considerations

General candidacy for bone-conduction implantation

Age considerations: Evidence supports use in children and adults in appropriate age groups; some devices have pediatric data (e.g., softband trials in infants) and others are studied in >=12 years
Refer to device-specific labeling and studies

Transcutaneous vs percutaneous selection: Transcutaneous (magnetic) devices offer better aesthetics and lower soft-tissue complication rates but may have some high-frequency attenuation; percutaneous devices provide direct osseointegration with established functional gains

Selection should consider audiologic goals, skin/soft-tissue risks, and patient preference

Bilateral implantation rationale: Bilateral BAHAs can provide improved thresholds, speech in quiet and noise, and localization compared with unilateral implantation but may have increased adverse-event risk; documentation should support bilateral need

Coverage when device-specific FDA/AAO-HNS criteria met

Coverage aligned to device-specific FDA indications and AAO-HNS appropriateness statements:

FDA-labeled adult candidates for semi-implanted middle-ear devices (example Vibrant): Patient is an adult (>=18 years) AND has audiometric results consistent with the device's labeled moderate-to-severe SNHL ranges (device lists per-frequency AC thresholds) AND word recognition score of 50% or better AND normal middle-ear anatomy AND psychologically/motivationally suitablesee device labeling per-frequency thresholds and WRS

Supported by FDA professional labeling and cited in policy

BAHA / fully or partially implantable bone-anchored devices: Patient has conductive or mixed hearing loss with PTA bone conduction thresholds better than device-specified cutoffs (e.g., better than 45 dB HL for BAHA) OR SSD with normal contralateral hearing (PTA AC <=20 dB) when CROS is not an optionBAHA: PTA BC <=45 dB HL; SSD: contralateral PTA AC <=20 dB HL

Per FDA clearances and labeling

Device-specific FDA indication criteria

Covered when ALL device-specific FDA indications are met:

General device eligibility: Patient meets device-specific age and audiometric PTA criteria as specified by the FDA clearance for the device (examples: age minimums range from any age for nonimplantable options to 12 years for some implants; PTA bone conduction thresholds vary by device and processor power).see device-specific thresholds

See individual device entries for exact PTA and age requirements (FDA labeling cited in policy).

Pre-implantation recommendation

Additional recommended preimplantation considerations:

Conservative trial: Prior experience with appropriately fitted air conduction or bone conduction hearing aids is recommended before implantation for devices such as Osia and BONEBRIDGE.N/A

Recommendation per FDA summaries and device labeling.

This policy does not apply to all states. For the states listed in the policy, refer to the applicable state-specific policy or guideline for coverage determinations. The states referenced in the policy include Idaho, Indiana, Kansas, Kentucky, Nebraska, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, and Tennessee; providers should follow the named state policy rather than this national policy when treating members in those jurisdictions.

The policy notes that intraoral bone conduction hearing aids (for example, the SoundBite™ system) have insufficient high-quality evidence to support routine coverage. Published studies were limited by small sample sizes, short follow-up, and lack of randomized controlled designs, and the SoundBite manufacturer ceased production; these limitations reduce confidence in both safety and durable effectiveness.

Devices for which the available evidence is of insufficient quality — including certain intraoral BCHAs, some laser or light-based contact hearing systems, and some totally implanted middle-ear systems — may be considered investigational or not medically necessary. The policy bases this stance on limitations such as lack of concurrent control groups, small cohorts, short follow-up, and conflicting safety findings in the literature.

There are currently no FDA‑approved intraoral bone conduction hearing aids available on the market. The SoundBite Hearing System previously received FDA clearance but manufacturing ended after the manufacturer filed for bankruptcy in 2015; no newer intraoral BCHA products are identified in the policy.

The policy explicitly lists several device categories as not supported by sufficient evidence: intraoral bone conduction hearing aids, laser or light-based hearing aids, and totally implanted middle‑ear systems. For these categories, the policy states the evidence is limited and does not demonstrate consistent efficacy and safety to meet routine coverage standards.

The limitations underlying the policy’s position on intraoral BCHAs include small study populations, short durations of follow-up, and lack of randomized or appropriately controlled trials. These methodological weaknesses reduce certainty about long‑term effectiveness and safety and are cited as the basis for deeming intraoral BCHAs not supported.

For laser/light-driven hearing devices and fully implantable middle‑ear systems, the policy cites insufficient high‑quality comparative evidence and limited long‑term outcome data. Studies often lack concurrent comparison groups and include small samples; some reports also note serious adverse events and conflicting findings, which prevent firm conclusions about comparative benefit and safety.

This Medical Policy is informational and must be applied in the context of the member’s benefit plan. Plan-specific federal, state, or contractual coverage requirements govern final coverage decisions, and providers should verify applicable prior authorization and benefit terms before proceeding with services.

Procedure, HCPCS, and Other Codes

Procedure/CPT and Category III codesCPT

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 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.

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HCPCS/V-codes and L-codes for wearable and implant componentsHCPCS

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.
S2230	Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear.
V5095	Semi-implantable middle ear hearing prosthesis.
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.

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Additional wearable hearing aid HCPCS codesHCPCS

V5255	Hearing aid, digital, monaural, ITC.
V5256	Hearing aid, digital, monaural, ITE.
V5257	Hearing aid, digital, monaural, BTE.
V5258	Hearing aid, digital, binaural, CIC.
V5259	Hearing aid, digital, binaural, ITC.
V5260	Hearing aid, digital, binaural, ITE.
V5261	Hearing aid, digital, binaural, BTE.
V5262	Hearing aid, disposable, any type, monaural.
V5263	Hearing aid, disposable, any type, binaural.
V5267	Hearing Aid or assistive listening device/supplies/accessories, not otherwise specified.

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Device classification (informational)mixed

No codes listed

Previously listed Applicable CPT/HCPCS codes (removed)mixed

92590	Fitting and Testing of Hearing Aids (removed from applicable codes list)
92591	Fitting and Testing of Hearing Aids (removed from applicable codes list)
92592	Fitting and Testing of Hearing Aids (removed from applicable codes list)
92593	Fitting and Testing of Hearing Aids (removed from applicable codes list)
92594	Fitting and Testing of Hearing Aids (removed from applicable codes list)
92595	Fitting and Testing of Hearing Aids (removed from applicable codes list)
S0618	Fitting and Testing of Hearing Aids (removed from applicable codes list)
V5010	Fitting and Testing of Hearing Aids (removed from applicable codes list)
V5011	Fitting and Testing of Hearing Aids (removed from applicable codes list)
V5014	Fitting and Testing of Hearing Aids (removed from applicable codes list)

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Degree of hearing loss thresholds — ASHA / Clark (1981)

Normal-10 to 15 dB HL

Slight16 to 25 dB HL

Mild26 to 40 dB HL

Moderate41 to 55 dB HL

Moderately severe56 to 70 dB HL

Severe71 to 90 dB HL

Profound

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended for BAHA/BCHA Implantation

Prior authorization is recommended for BAHA/BCHA (bone-anchored) implantation. Providers should obtain prior authorization or a coverage determination when requesting surgical implantation of bone-anchored or semi-implantable bone conduction hearing systems.

Applicable when implantation is planned (surgical placement of osseointegrated implants or transcutaneous magnetic systems)

Documentation Required

Confirm FDA Labeling Criteria

Confirm that the individual meets device-specific FDA labeling and selection criteria. Prior authorization reviews should include documentation that the candidate meets the audiologic and clinical selection criteria specified in the device's FDA professional labeling (examples include pure-tone threshold ranges, word recognition score minimums, and age requirements).

Document device model and reference FDA labeling (e.g., Vibrant Soundbridge, BAHA/Baha systems, BONEBRIDGE, Osia)

Background and Scope

Hearing aids function either by amplifying sound (air‑conduction hearing aids) or by transmitting vibration to the cochlea (bone‑conduction devices) to treat hearing impairment. Wearable air‑conduction hearing aids are the standard treatment when they can correct the impairment; bone‑anchored and semi‑implantable electromagnetic devices are alternative options when air‑conduction aids are not suitable or effective.

Key Definitions

Conductive Hearing Loss — definition and typical correctability

DefinitionOccurs when sound is not conducted efficiently through the outer ear canal to the eardrum and ossicles; often correctable medically or surgically (ASHA)

Typical mechanismCauses include outer or middle ear pathology that reduces sound level or ability to hear faint sounds

Treatment implicationsOften correctable medically or surgically; bone-conduction devices are alternatives when air-conduction aids are not suitable

Sensorineural Hearing Loss — definition

DefinitionDamage to the inner ear (cochlea) or the nerve pathways from the inner ear to the brain; usually permanent and not correctable surgically (ASHA)

Common outcome

Policy Revision History

06/01/2026policy_revisionLatest

Updated definition of 'Conductive Hearing Loss' and updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information; removed list of applicable CPT/HCPCS codes for fitting and testing of hearing aids.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS052.V

Change TypeDefinition updatecode list removalcontent updates

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and document device-specific FDA audiometric selection criteria and prior trial use when applicable.

SourceLink

On This Page

Based on systematic reviews showing mixed quality evidence

Use of alternative devices when conventional aids insufficient:

Patients who are unable or unwilling to use conventional air-conduction hearing aids and meet device-specific criteria may be considered for implantation or alternative devices (e.g., intraoral BCHA, light-driven contact hearing aid, totally implanted middle-ear device)

document prior attempts or intolerance to conventional aids

AAO-HNS supports active middle-ear implants for selected adults; evidence for some alternative devices is limited

Pure Tone Average (PTA) bone conduction threshold — device-specific ranges

Common device cutoff — 45 dB HLPTA bone conduction thresholds commonly required ≤45 dB HL for several BAHA/BCHA processors

Intermediate power processors — 55 dB HLSome devices/processors (e.g., BP110, Osia indications) allow PTA BC ≤55 dB HL

High-power processors — 65 dB HLSuperPower processors (e.g., Cordelle II, Baha 5 SuperPower) may be indicated up to ≤65 dB HL

Device-specific requirementExact PTA BC threshold depends on device and sound processor; verify FDA labeling

PTA air conduction threshold for normal hearing (contralateral ear in SSD)

Normal hearing (contralateral ear for SSD)PTA air-conduction threshold better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz)

Use in SSD labelingSeveral device indications (e.g., Sophono, Cochlear Baha, Osia, BONEBRIDGE) specify contralateral PTA AC ≤20 dB HL for SSD candidacy

Measurement frequenciesPTA defined at 0.5, 1, 2, and 3 kHz per device labeling

Osia system fitting range and related device notes

Osia system fitting range55 dB (system fitting range as stated in FDA documentation)

Indicated agesPatients 12 years of age or older for Osia systems per FDA indications

PTA bone conduction eligibilityOsia Systems: PTA BC thresholds indicated up to 55 dB HL for conductive/mixed loss per labeling

Provide audiometric data demonstrating thresholds and WRS consistent with the device labeling

Prior Authorization

Confirm Plan Coverage and Prior Authorization

Verify the member’s benefit plan terms and any prior authorization requirements before proceeding. Coverage is determined by the member’s federal, state, or contractual benefit plan terms; these may impose additional limits or requirements beyond this policy.

Check member benefits for surgical implant coverage, device exclusions, and preauthorization procedures
Obtain prior authorization when required by the member’s plan

Note

Candidate Selection and Device Labeling

Candidate selection must align with device labeling. Patients who do not meet the audiometric or clinical selection criteria specified in FDA labeling or device instructions for use may be ineligible for coverage.

Ensure documented inability or unwillingness to use air-conduction hearing aids when implants are requested
For bilateral implant consideration, document symmetry criteria when required (e.g., interaural threshold differences)

Note

Plan Terms Govern

Plan terms govern coverage decisions. When there is any conflict between this policy and the member’s plan (federal, state, or contractual) or applicable law, the plan or law controls. Always reference applicable benefit plan documents when making coverage determinations.

Federal, state, and contractual benefit provisions may require coverage or impose restrictions that differ from this policy

Documentation Required

Device-Specific Labeling Documentation

Document device-specific audiometric selection criteria in the medical record. Prior authorization submissions should include the FDA-specified audiometric data and any other device labeling requirements relied upon to justify the request.

Include device model and FDA labeling reference with submission
Provide pure-tone thresholds (PTA) and frequencies used to calculate PTA, and Word Recognition Scores (WRS) where required
Include age and other clinical criteria noted in the device labeling

Documentation Required

Document FDA-Specified Audiometric Criteria and Prior Noninvasive Therapy

Document FDA-specified audiometric criteria and prior noninvasive therapy attempts. Medical records should show the audiometric thresholds (PTA values at specified frequencies), WRS, patient age, and evidence of prior trial or experience with appropriately fitted air-conduction or bone-conduction devices when indicated.

Provide PTA (specify frequencies and ear) and WRS results used to determine device eligibility
Document trial use of nonimplantable bone conduction devices (softband, headband, adhesive systems) or appropriately fitted air-conduction hearing aids prior to implantation when applicable
If the patient could not benefit from or could not use air-conduction aids, document rationale

Note

Preferred Initial Device

Preferred initial device: wearable air-conduction hearing aids are the standard first-line treatment when they can correct the impairment. Implantable or semi-implantable devices are generally considered when patients cannot benefit from or are unable/unwilling to use air-conduction hearing aids.

Confirm that appropriately fitted wearable air-conduction hearing aids were trialed and documented as ineffective or not tolerated before proceeding to implantable options when clinically appropriate

Most common type of permanent hearing loss; managed with amplification or implantable devices when appropriate

Relation to mixed lossMay occur with a conductive component (mixed hearing loss) when both inner and middle/outer ear are involved

Degree of Hearing Loss — categories and dB HL ranges

Normal-10 to 15 dB HL

Slight16 to 25 dB HL

Mild26 to 40 dB HL

Moderate41 to 55 dB HL

Moderately severe56 to 70 dB HL

Severe71 to 90 dB HL

Profound91 dB HL or more

Percutaneous BCHA — definition

DefinitionAn implantable bone-anchored hearing aid that uses a titanium screw osseointegrated into the mastoid with a skin-penetrating abutment to link an external sound processor

MechanismTransmits mechanical vibration directly to the skull via osseointegration and an abutment

Clinical noteProvides established functional gains but has potential soft-tissue complication risks related to the abutment

Transcutaneous (magnetic) BCHA — definition

DefinitionPartially implantable devices with a subdermal magnetic implant that couples to an external processor across intact skin (no skin-penetrating abutment)

ExamplesSophono/Otomag Alpha, Cochlear Baha Attract, BONEBRIDGE, Osia (partially transcutaneous components)

Clinical trade-offsOffer improved aesthetics and lower skin complication rates but may have some high-frequency attenuation compared with percutaneous systems

Intraoral BCHA — definition and evidence status

DefinitionA non-surgical, oral-retainer-based bone conduction device that transmits vibrations via the teeth to the cochleae (example: SoundBite)

StatusSoundBite manufacturer filed for bankruptcy; no currently available FDA-approved intraoral BCHAs

EvidenceInsufficient high-quality evidence (small studies, short follow-up) to support routine coverage

Light-based and middle-ear implant — definition

DefinitionDevices that transmit sound via light pulses to a tympanic transducer (e.g., Earlens) or fully implant a middle‑ear sensor/driver system to directly stimulate the ossicular chain or cochlea (e.g., Esteem)

ComponentsMay include an external light‑based processor and a tympanic transducer or fully implanted sensor, driver, and processor components

EvidenceLaser/light-based and totally implantable middle-ear systems lack high-quality comparative evidence and are considered unproven in many cases

Single-Sided Deafness (SSD) — definition

DefinitionUnilateral sensorineural deafness in one ear with normal or near-normal hearing in the contralateral ear

Audiometric definitionContralateral (hearing) ear PTA air conduction threshold better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz) per device labeling

ImplicationSSD is an FDA-specified indication for several bone-conduction devices when the patient cannot or will not use a CROS system

Vibrant Soundbridge selection criteria (example)

Age criterionAdults aged 18 years or older

PTA air-conduction per-frequency ranges500 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

Word recognitionWord Recognition Score ≥50% using recorded material

Single-sided deafness (SSD) — audiometric PTA air-conduction thresholds

Audiometric definition (profound unilateral SNHL)Unilateral profound sensorineural hearing loss with normal or near-normal hearing in the contralateral ear; contralateral PTA AC better than or equal to 20 dB HL

Device labeling consistencyMultiple partially implantable and nonimplantable devices specify the same contralateral PTA AC ≤20 dB HL criterion for SSD

Clinical useSSD indication often applied when patient cannot use or will not use an air conduction CROS system

Symmetrical bone conduction thresholds — definition

Symmetry definition (average)Less than a 10-dB average interaural difference in bone conduction thresholds (measured at 0.5, 1, 2, and 3 kHz)

Symmetry definition (individual frequencies)Less than a 15-dB difference at individual frequencies

ContextUsed to determine bilateral fitting candidacy for many BAHA/BCHA systems