Implantable Bone-Conduction and Bone-Anchored Hearing Prosthetic Devices
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Medical necessity and coverage criteria for implantable bone-conduction (bone-anchored) hearing prosthetic devices for members aged 5 years and older, including device indications, audiologic thresholds, and investigational uses.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity
Medical necessity criteria
Covered when ALL of the following are met:
Main eligibility
- Medical criteria: Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear; OR chronic external otitis or otitis media; OR tumors of the external canal and/or tympanic cavity; OR dermatitis of the external canal.
Any ONE qualifies
- Audiologic thresholds: A BC pure-tone average measured at 0.5, 1, 2, and 3 kHz that is ≤45 dB for OBC and BP100 devices, ≤55 dB for the Intenso device, or ≤65 dB for the Cordele II device. For bilateral implantation, symmetric conductive or mixed hearing loss is required: difference between left and right BC PTA <10 dB on average measured at 0.5, 1, 2, and 3 kHz (4 kHz included for OBC and Ponto Pro), or <15 dB at individual frequencies.BC PTA <=45/55/65 dB; bilateral symmetry <10 dB average or <15 dB at individual frequencies
Device-specific thresholds and bilateral symmetry requirements
- Single-sided deafness (SSD) alternative: For SSD candidacy as an alternative to an air-conduction CROS hearing aid: patient is ≥5 years of age and has single-sided sensorineural deafness with normal hearing in the contralateral ear. The contralateral (normal) ear must have an air-conduction PTA ≤20 dB measured at 0.5, 1, 2, and 3 kHz.AC PTA <=20 dB (0.5,1,2,3 kHz)
SSD path — device as alternative to AC CROS
Investigational / Not established
Policy states insufficient evidence
Coverage by indication
Evidence sufficient for improvement in net health outcome
Quality RCTs lacking; evidence insufficient
Use of implantable bone-conduction (bone-anchored) hearing aids in individuals with bilateral sensorineural hearing loss is considered investigational. The policy states there is insufficient evidence to support a general conclusion about health outcomes or benefits for this indication, and therefore such use is not covered under the medical necessity criteria.
The policy does not list specific procedural exclusions by code for implantable bone-conduction devices; however, for unilateral sensorineural hearing loss (single-sided deafness) the evidence is judged to be insufficient. A systematic review and small randomized trial did not demonstrate improved speech recognition or localization compared with contralateral routing of signal (CROS) hearing aids, and quality RCTs are lacking, so the policy does not support this indication as proven to improve net health outcome.
General exclusions from coverage applicable to medical services are referenced to the Centers for Medicare & Medicaid Services Medicare Policy Benefit Manual, Chapter 16 — General Exclusions from Coverage. Specific CMS exclusion text is cited in the policy references but the policy does not reproduce the full CMS exclusion list within its body.
Any uses of implantable bone-conduction (bone-anchored) hearing aids that are not explicitly enumerated as covered in this policy are considered investigational. The policy explicitly notes that other unspecified applications, including use in members with bilateral sensorineural loss, lack sufficient evidence to determine a net health benefit.
Use of implantable bone-anchored hearing devices for unilateral sensorineural hearing loss (single-sided deafness) is considered unsupported by sufficient evidence to determine an improvement in net health outcome. Although some case series report patient-reported improvements, a systematic review and the available small RCT did not show clear benefit in speech recognition or localization compared with CROS hearing aids.
Codes and Audiologic Thresholds
| MAH | FDA product code for implanted bone-conduction hearing aid |
| LXB | FDA product code for bone-anchoring hearing aid |
| MAH | Several implantable bone-conduction hearing systems have been approved by the U.S. Food and Drug Administration for marketing through the 510(k) process (Table 2). Product codes: MAH, LXB |
| MAH | FDA product code (for implanted bone-conduction hearing aid) |
| LXB | FDA product code (for bone-anchoring hearing aid) |
| Note | List of codes may not be all-inclusive; inclusion does not denote coverage — verify prior authorization and benefit terms. |
| C30.1 | Malignant neoplasm of middle ear |
| D23.21 | Other benign neoplasm of skin of right ear and external auricular canal |
| D23.22 | Other benign neoplasm of skin of left ear and external auricular canal |
| H60.60 | Unspecified chronic otitis externa, unspecified ear |
| H60.61 | Unspecified chronic otitis externa, right ear |
| H60.62 | Unspecified chronic otitis externa, left ear |
| H60.63 | Unspecified chronic otitis externa, bilateral |
| H61.301 | Acquired stenosis of right external ear canal, unspecified |
| H71.11 | Cholesteatoma of tympanum, right ear |
| H90.0 | Conductive hearing loss, bilateral |
| Note | Additional specific external ear canal and chronic otitis media codes are listed in the policy text; providers should reference the full ICD-10 listing. |
| 69716 | code added per policy history |
| 69719 | code added per policy history |
| 60726 | code added per policy history |
| 69727 | code added per policy history |
| 69728 | code added per administrative update |
| 69729 | code added per administrative update |
| 69730 | code added per administrative update |
| 0725T | temporary code previously associated; removed 04/07/2023 |
| 0726T | temporary code previously associated; removed 04/07/2023 |
| 0727T | temporary code previously associated; removed 04/07/2023 |
| History | Codes were added and removed on multiple dates per the policy history; verify current applicability before billing. |
Prior Authorization, Documentation, and Billing
Medical necessity prior authorization required
Obtain prior authorization to confirm the member meets the policy's medical necessity requirements, including age (≥5 years), qualifying medical indication (e.g., congenital or surgically induced malformations, chronic external otitis/otitis media, tumors, dermatitis), and device-specific bone-conduction pure-tone average thresholds as specified by the policy.
- PA must confirm patient is ≥5 years of age.
- PA must confirm presence of at least one qualifying medical criterion listed in policy.
- PA must confirm device-specific BC PTA thresholds (≤45, ≤55, or ≤65 dB as applicable) measured at 0.5, 1, 2, and 3 kHz.
Confirm PA applicability for listed CPT/HCPCS codes
Verify whether the procedure and supply codes being billed are subject to prior authorization; the policy provides a list of CPT/HCPCS codes but notes the list may not be all-inclusive and codes can change.
- Refer to the policy's coding section and check payer-specific PA requirements before submitting.
- Do not assume inclusion in the policy's code list guarantees coverage or PA exemption.
Verify code applicability and PA given coding history
Confirm the current applicability of specific procedure codes and whether prior authorization is required, because the policy history shows codes have been added and removed over time.
Step therapy: implantable devices as an alternative to AC aids/CROS
Use implantable bone-conduction devices only after less invasive air-conduction hearing aids or CROS have been determined inappropriate or intolerable, per policy positioning of implantable devices as an alternative.
- Document attempts and intolerance or inappropriateness of AC hearing aids or CROS when applicable.
Verify coverage and reimbursement — inclusion of codes doesn't ensure payment
Ensure coding and authorization verification prior to claim submission; inclusion of a code in the policy does not by itself confirm coverage — check member benefits and PA rules.
- Contact Provider Services or Member Services for coverage or PA questions.
- Confirm whether services are eligible for separate reimbursement under the member's benefit plan.
Document preoperative skull bone assessment and hygiene ability
Before implantation, document assessment of skull bone quality and thickness and document that the patient or caregiver can maintain hygiene to reduce infection risk and ensure implant/abutment stability.
- Record objective assessment of skull bone adequacy for implant stability.
- Document education or demonstrated ability of patient/caregiver to perform percutaneous implant hygiene.
Coding and billing note — coverage depends on member benefits
When preparing claims, note that the policy's coding information is informational only; final reimbursement depends on member benefit terms, eligibility on date of service, and whether services are separately reimbursable.
- Do not rely solely on the policy code list to determine coverage or billing status.
- Confirm benefit plan limitations or exclusions that may affect payment.
Ensure current coding per recent administrative updates
Use the most current procedure and diagnosis codes when submitting authorizations and claims, since the policy history documents multiple administrative and coding updates.
- Review recent policy history and administrative updates for newly added or removed codes before billing.
Eligibility-related denial risk if criteria not met
Anticipate potential denials if the member does not meet age, specified medical indications, or the device-specific audiologic thresholds required by the policy.
- Confirm member is ≥5 years old, has one of the listed qualifying medical conditions, and meets the device-specific BC PTA thresholds (or AC PTA ≤20 dB for SSD candidacy).
Confirm benefits, eligibility, and medical necessity before proceeding
Verify member benefit coverage, eligibility on the date of service, and that the requested services meet medical necessity; policies are not guarantees of coverage or payment.
- Confirm member eligibility and benefit limitations/exclusions prior to scheduling surgery or device provision.
- Obtain PA where required to document medical necessity for claims processing.
Coding and administrative risk — incorrect or outdated codes may affect claims
Be aware that administrative updates and coding revisions in the policy's history may affect claims processing; incorrect or outdated coding can result in administrative denials or processing issues.
- Monitor policy history for code additions/removals and apply current codes on claims.
- Coordinate with billing staff to avoid using temporary codes that have been removed from this policy.
Clinical Background
Hearing loss can be classified as conductive, sensorineural, or mixed, with varying degrees of severity. Implantable bone-conduction systems transmit sound through skull vibration — either via a percutaneous titanium implant that achieves osseointegration or via a transcutaneous magnetic coupling to an implanted component — to bypass the external and middle ear and stimulate the cochlea. These devices are primarily indicated for conductive or mixed hearing loss and, in selected cases, as an alternative to air-conduction CROS systems for single-sided deafness when candidacy criteria are met.
Key Terms and Definitions
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