CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria: Bone Anchored and Bone Conduction Hearing Systems

Clinical review criteria governing medical necessity, coding, and authorization for bone-anchored and transcutaneous bone-conduction hearing systems (e.g., BAHA, Bonebridge, OSIA, Softband, Adhear, Vibrant Soundbridge) for Kaiser Foundation Health Plan of Washington members and their providers.

Policy Summary

PayerKaiser Permanente

PolicyBone Anchored and Bone Conduction Hearing Systems clinical review criteria

Policy CodePolicy N/A

Change TypeCriteria revisions and additions (material)

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain pre-authorization and submit the most recent audiogram and clinical notes to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

MPC approved the recommended changes for Bone Anchored Hearing System hybrid criteria.

MPC approved modification to criteria to include OSIA and clarification to hearing thresholds.

BAHA approved for the Care Delivery Medical Necessity Review program.

Adhear was added to non-coverage statement for Vibrant Soundbridge related policy revisions.

manyprocedure and device codes referenced

KP-0564MCG guideline used for Non‑Medicare

limitedMTAC evidence conclusion

CMS citedMedicare guidance noted

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Coverage Criteria and Medical Necessity

Coverage by member type

Coverage is determined by member type and meeting the applicable policy/MCG criteria.

Medicare members: Follow CMS Coverage Manuals Chapter 16 section 100 and section 180; Medicare covers devices that replace the function of the middle ear, cochlea, or auditory nerve. No NCD or LCD specified.

Non-Medicare members: Kaiser Permanente uses MCG KP-0564 (Hearing Aids, Bone Anchored and Bone Conduction, KP-0564 09.01.2025) for medical necessity determinations; Non‑Medicare coverage when the applicable MCG criteria are met. The proprietary MCG criteria may be requested from Kaiser Permanente Clinical Review staff for individual utilization decisions.

Providers may request specific MCG criteria when used for a utilization decision

The Medical Technology Assessment Committee (MTAC) reviewed the evidence for implantable middle‑ear and bone‑anchored hearing devices and found the published literature limited primarily to case series with small samples and no controlled trials. For the Vibrant Soundbridge the review identified mostly European case series (the largest n=125) and a U.S. study (n=54) that informed FDA approval; for BAHA the evidence similarly consisted of multiple small case series. MTAC concluded that this body of evidence did not meet Kaiser Permanente’s Medical Technology Assessment Criteria for routine coverage.

Device‑specific coverage statements in this policy reflect those findings: the Vibrant Soundbridge system and BAHA devices are addressed separately in coverage determinations. Portions of this policy list BAHA and other bone‑anchored/transcutaneous bone‑conduction systems as potentially considered medically necessary when applicable criteria are met (see CPT/HCPCS groupings and member‑type distinctions), while the Vibrant Soundbridge and related semi‑implantable middle‑ear prosthesis codes are identified in sections of the policy as not medically necessary based on the MTAC assessment.

The Vibrant Soundbridge and its related procedure codes are addressed as Not Medically Necessary in this policy. Specifically, semi‑implantable middle ear device codes such as S2230 (implantation of magnetic component of semi‑implantable hearing device on ossicles in middle ear) and V5095 (semi‑implantable middle ear hearing prosthesis) are listed in the policy’s Vibrant Soundbridge not‑medically‑necessary section.

Providers should verify current pre‑authorization requirements for any specific CPT or HCPCS code through the plan’s Pre‑authorization Code Check, and submit required clinical documentation (most recent audiogram and specialist notes) when requesting coverage determinations, recognizing that the not‑medically‑necessary designation for Vibrant Soundbridge is based on MTAC’s finding of limited evidence from case series.

Procedure, HCPCS and CPT Coding

Considered Medically Necessary CPT Codes (Non-Medicare & Medicare groups listed)CPTCovered

69710	bone.
69711	Removal or repair of electromagnetic bone conduction hearing device in temporal bone.
69714	Implantation, osseointegrated implant; temporal bone, with percutaneous attachment to external speech processor/ cochlear stimulator; without mastoidectomy.
69715	Implantation, osseointegrated implant; temporal bone, with percutaneous attachment to external speech processor/ cochlear stimulator; with mastoidectomy.
69716	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor.
69717	Replacement (including removal of existing device), osseointegrated implant; temporal bone, with percutaneous attachment to external speech processor.
69718	Replacement (including removal of existing device), osseointegrated implant; temporal bone, with percutaneous attachment to external speech processor/ cochlear stimulator; with mastoidectomy.
69719	Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor.
69726	Removal, entire osseointegrated implant, skull; with percutaneous attachment to external speech processor.
69727	Removal, entire osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor; within the mastoid and/or involving bony defect less than 100 sq mm.

1–10 of 13

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Applicable HCPCS and other codesHCPCSCovered

L8690	Auditory osseointegrated device - includes all internal and external components.
L8691	Auditory osseointegrated device, external sound processor, excludes transducer/actuator; replacement only, each.
L8692	Auditory osseointegrated device, external sound processor used without osseointegration, body worn; includes headband or other means of external attachment.
L8693	Auditory osseointegrated device abutment - any length - replacement only.
S2230	Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear.
V5095	Semi-implantable middle ear hearing prosthesis.

inv-06: Hearing aid experience prior to implant — FDA recommendation about prior use of appropriately fitted conventional hearing aids

FDA recommendationPatients should have experience with appropriately fitting conventional hearing aids before using the Vibrant Soundbridge.

System componentsConsists of an implanted Vibrating Ossicular Prosthesis (VORP) and an external Audio Processor that drives a Floating Mass Transducer (FMT) to vibrate the ossicles.

Mechanism of actionAudio Processor converts sound to electrical signals delivered to the VORP; the FMT vibrates to stimulate the auditory ossicles and produce perceived sound.

Availability and approvalCommercially available in Europe since 1998; FDA approval in the U.S. in August 2000.

Potential risksIncludes usual risks of major ear surgery and possible decrease in residual hearing.

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the procedure and device codes listed below. Submit a prior authorization request before scheduling or performing the service to avoid denial of payment.

Affected CPT codes: 69711, 69714, 69715, 69716, 69717, 69718, 69719, 69726, 69727, 69728, 69729, 69730
Affected HCPCS codes: L8690, L8691, L8692, L8693

Note

Use of Guideline and Prior Device Experience

Kaiser Permanente uses the MCG guideline "Hearing Aids, Bone Anchored and Bone Conduction (KP-0564)" for non‑Medicare medical necessity determinations. Providers may need to document prior hearing aid use or other prior device experience per the MCG criteria. If Vibrant Soundbridge or other technologies are being requested, note that evidence may be insufficient and additional justification may be required.

Device Definitions

inv-12: Vibrant Soundbridge — implantable middle-ear system description

Device descriptionAn implantable middle‑ear system composed of an implanted Vibrating Ossicular Prosthesis (VORP) and an external Audio Processor.

Floating Mass Transducer (FMT)Component of the VORP that vibrates to manually stimulate the auditory ossicles.

External Audio ProcessorWorn behind or above the ear (~1.2 inches diameter) containing a microphone that converts environmental sound to electrical signals delivered to the VORP.

Intended effectVibrations produced by the FMT are perceived by the patient as sound via ossicular stimulation.

Approval and historyAvailable commercially in Europe since 1998; FDA-approved in the U.S. in August 2000.

inv-13: BAHA (Bone Anchored Hearing Aid) — titanium implant with external sound processor description

Background and Clinical Context

Bone‑anchored and implantable middle‑ear devices (for example, BAHA and Vibrant Soundbridge) are alternatives to conventional air‑conduction hearing aids for patients with conductive or mixed hearing loss, single‑sided deafness, or those who cannot tolerate devices placed in the ear canal. The Vibrant Soundbridge is an implantable middle‑ear system that couples a Floating Mass Transducer to the ossicles; BAHA systems transmit sound by bone conduction via a titanium implant and external processor. Evidence available to date consists mainly of case series with limited sample sizes and follow‑up, and MTAC determined that these studies do not provide the controlled data typically required to establish broad coverage.

Policy Changes and Revision History

2018-10-09policy_update

Adhear was added to the non-coverage statement for Vibrant Soundbridge-related policy sections.

2020-04-21coding_update

Applicable CPT codes 69714, 69715, 69717, and 69718 were added to the policy.

2020-08-04MPC_approval

MPC approved adoption of updates for Non-Medicare, adding clinical indications for BONEBRIDGE (MCG KP-0564) with a required 60-day notice effective 2021-01-01.