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Modifiedblue cross blue shield - south dakotaPolicy 01.01.27

Bone Conduction Hearing Devices

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This policy governs medical necessity and coverage criteria for implantable and non-implantable bone-conduction and bone-anchored hearing devices for Wellmark/Blue Cross Blue Shield - South Dakota members, including prior approval requirements and replacement device criteria.

Policy Summary

Payerblue cross blue shield - south dakota

PolicyBone Conduction Hearing Devices

Policy CodePolicy 01.01.27

Change TypeAdministrative update (review date and revision noted)

Effective DateApr 1, 2015

Last ReviewJun 1, 2025

Next Review Date

Key ActionObtain prior authorization for implantable bone-conduction device requests and document preimplant audiologic testing and prior trial of external hearing aids when applicable.

SourceLink

POLICY UPDATE CHANGES

Review Date updated to June 2025 and policy revised February 2025.

Prior approval requiredauthorization requirement for most codes

>=5 yrsminimum age for implantable devices

Investigationalinvestigational uses listed

MultipleFDA-cleared devices listed

3–6 moosseo integration period

Coverage Criteria and Medical Necessity

Conductive or Mixed Hearing Loss — Implantable BAHA coverage criteria

Covered when ALL of the following are met:

Age: Individual is 5 years of age or older>=5 years

Applies to fully or partially implantable bone-conduction (bone-anchored) hearing aid(s)

Medical indications: One or more of the following: congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear; chronic external otitis or otitis media; dermatitis of the external canal; tumors of the external canal and/or tympanic cavity; or other conditions in which an air-conduction hearing aid is contraindicated.

From policy medical criteria

Audiologic criteria: Conductive or mixed hearing loss with pure-tone average bone-conduction thresholds (0.5, 1, 2, and 3 kHz) within device-specific FDA indications (examples include ~45 dB for OBC/BP100, 55 dB for Intenso, 65 dB for Cordele II). For bilateral implants, symmetric conductive or mixed loss required (average interaural bone-conduction difference <10 dB across 0.5, 1, 2, and 3 kHz, or <15 dB at individual frequencies, or device-specific symmetricity per labeling).

Policy Summary

Payerblue cross blue shield - south dakota

PolicyBone Conduction Hearing Devices

Policy CodePolicy 01.01.27

Change TypeAdministrative update (review date and revision noted)

Effective DateApr 1, 2015

Last ReviewJun 1, 2025

Next Review Date

Key ActionObtain prior authorization for implantable bone-conduction device requests and document preimplant audiologic testing and prior trial of external hearing aids when applicable.

SourceLink

On This Page

device-specific thresholds

See Table PG1 for air-conduction ranges and device labeling for exact bone-conduction limits

Single-Sided Sensorineural Deafness

Covered when ALL of the following are met:

Age: Individual is 5 years of age or older>=5 years

Applies to implantable bone-conduction devices for SSD

Contralateral ear hearing: Normal hearing in the other ear with pure-tone average air-conduction threshold better than 20 dB measured at 0.5, 1, 2, and 3 kHz.<=20 dB

Specific requirement for single-sided sensorineural deafness indication

Transcutaneous Worn (Softband/Headband) Devices

Covered when the following applies:

Transcutaneous softband/headband devices: Non-implantable transcutaneous bone-conduction devices using a headband or softband may be considered medically necessary in any age group when the applicable audiologic criteria for the specific type of hearing loss are met.

Often used for testing, temporary use, or for children (e.g., Baha Softband) — no implantation required

Medical necessity — implantable and semi-implantable bone-conduction devices

Covered when ALL of the following are met (device-specific FDA-cleared indications and general clinical candidacy):

Device candidacy (FDA indications)

Example labeled indications: Conductive or mixed hearing loss; single-sided deafness where indicated; candidates for AC CROS who cannot or will not wear AC CROS devices.clinical
Device examples and indications referenced in FDA summaries

Audiometric criteria: Audiometric thresholds and speech/discrimination scores within device-specific limits per FDA labeling (e.g., pure-tone and word-recognition thresholds as specified by each device).audiometric/device-specific

Refer to device labeling and Table PG1 for air-conduction ranges and to device summaries for bone-conduction limits

Anatomic and surgical considerations: Adequate skull bone quality and thickness for implant stability; appropriate middle ear anatomy or adequate space when required (e.g., Esteem requires CT assessment for implant space).anatomic

Assessment of skull bone and middle ear anatomy recommended per policy guidelines

Functional and caregiver considerations: Patient (or caregiver) able to perform hygiene and care for percutaneous abutments if applicable; patient is psychologically suitable with realistic expectations; prior experience or documented trial with appropriately fitted external hearing aids when required by device labeling.functional

Documented ability and willingness to maintain implants and follow-up care required

Evidence-supported candidate criteria

Evidence summary and intended populations

Target populations: Patients with conductive or mixed hearing loss (including pediatric patients) being considered for implantable BAHA systems, including percutaneous abutment systems and partially implantable transcutaneous (magnetic coupling) systems.

Populations repeatedly specified in evidence summaries

Device options: Percutaneous BAHA with abutment OR partially implantable transcutaneous BAHA (magnetic coupling) as alternatives to external acoustic hearing aids.

Interventions described in document (percutaneous vs transcutaneous distinctions)

Outcomes and follow-up expectations: Studies report improvements in functional outcomes, speech understanding, and quality of life; at least 1 year of follow-up is considered necessary to fully observe outcomes and complications.>=1 year follow-up

Follow-up duration emphasized in evidence sections

Evidence summaries mapped to coverage considerations

Summary of evidence-based coverage-relevant findings

Partially implantable transcutaneous BAHAs: Multiple retrospective within-subjects comparisons and small prospective studies generally demonstrate within-subject audiologic and functional improvements after implantation, though measures and timing are heterogeneous.

Evidence base primarily observational with some small prospective trials

Bonebridge and fully implantable systems: Case series report meaningful PTA improvements in many series and variable complication rates; sample sizes vary across cohorts.

Case series and cohort data summarized for Bonebridge/fully implantable systems

BAHA devices for unilateral SNHL (SSD): Controlled and prospective studies show mixed audiologic results — no consistent improvement in localization; speech-in-noise and subjective measures may improve, and outcomes are often similar to AC CROS devices in comparative studies.

Systematic reviews and prospective studies report mixed findings

Pediatric considerations (<5 years): Transcutaneous softband devices (e.g., Baha Softband) are used in children younger than 5 years; surgical implantation is generally reserved for >=5 years. Pediatric series report improved QoL but variable skin-reaction rates and need for careful monitoring.

Softband cleared for <5 years; implantation age thresholds noted in device summaries

Coverage criteria for implantable hearing devices

Covered when ALL of the following are met:

Candidate qualification: Patient is unable to use or is dissatisfied with external acoustic hearing aids (documented trial) or is not a candidate for cochlear implantation.

External hearing aids are primary comparator; prior trial recommended

Preimplant evaluation and documentation: Preimplant audiologic testing documenting baseline unaided and best-aided performance and justification for implantable device selection; document expected functional gain and follow-up plan.

Functional gain and expected benefit should be documented per device trials

Informed consent and risk discussion: Patient/caregiver informed of surgical risks (e.g., infection, soft tissue complications, possible decrease in residual hearing, need for revision/explantation, anesthesia risks) and agrees to surgical follow-up and monitoring (typically 6–12 months minimum for some devices).

Balance modest improvements against surgical risks for implantable middle ear aids

Evidence-based patient selection

Evidence and clinical context supporting use:

Study-based patient context: Patients evaluated in trials generally had failed conservative treatments (including optimally fitted external hearing aids) and were selected for performance measures including functional gain, speech recognition, and patient-reported outcomes.

Evidence draws from systematic reviews and observational cohorts

Coverage criteria for implantable hearing devices

Covered when ALL of the following are met:

Preimplantation requirements: Documented inability to use or lack of benefit from conventional external hearing aids (best-fit), with objective audiologic testing comparing unaided and best-aided conditions prior to consideration of implantable device.

Documentation of trials and outcomes expected for prior authorization

Evidence of expected benefit: Clinical evidence supports improvement in sound-field thresholds and some speech measures versus unaided condition; modest benefit over best-fit aids in some studies — expected benefit should be reasonable to justify surgical risk.

Benefit magnitude varies by device and patient; document expected functional gain

Risk, durability, and consent considerations: Patient counseling and documentation that patient accepts surgical risks (including potential taste disturbance, facial paresis, device revision/explantation) and understands uncertain long-term durability for some devices.

High replacement/explant rates reported in some cohorts; informed consent required

Supplemental evidence and expert opinion

Supplemental guidance and evidence that inform coverage determinations

Professional society guidance: AAO-HNS considers bone conduction hearing devices appropriate, and in some cases preferred, for conductive and mixed hearing loss and select single-sided deafness; recommendations should be determined by a qualified otolaryngology–head and neck surgeon and adhere to FDA/regulatory restrictions.

AAO-HNS position statement (2021 update)

Expert consensus: A 2022 consensus statement provides guidance on patient education and technical aspects of device placement but does not specify clear superiority of implantable middle ear hearing aids over alternatives for particular patient subgroups.

Consensus statement referenced

Clinical input: Specialty society and academic input (2016) indicated that partially implantable devices are an evolution of earlier devices; direct comparative trials between partially and fully implantable devices were not considered essential by respondents.

Clinical input summarized

The policy identifies several uses as investigational and therefore not covered due to insufficient evidence of net health benefit. Examples specifically listed include individuals with bilateral sensorineural hearing loss, BAHA use in children younger than 5 years, severe hearing loss, and semi‑ and fully implantable middle ear hearing aids. These items are called out as investigational because available studies do not adequately demonstrate improved long‑term outcomes for these populations.

The document notes that certain devices either lack FDA approval or have manufacturer status that affects availability and coverage. For example, the fully implantable Carina device is still in development and has not received FDA approval, and the SoundBite system’s manufacturer ceased operations in 2015 despite prior 510(k) clearance. The policy therefore flags devices not FDA‑approved or from discontinued manufacturers as potentially not covered and advises verification of device regulatory status when considering coverage.

The evidence base for many device comparisons is limited and largely consists of small observational studies and heterogeneous populations; therefore the policy does not list numerous explicit exclusions in the main evidence sections. Instead, it emphasizes that evidence limitations — small sample sizes, observational designs, and heterogeneity — constrain generalizability, and these limitations inform coverage determinations where randomized or comparative data are lacking.

For single‑sided deafness (SSD), systematic reviews and case series show inconsistent benefits for auditory localization after implantation. While some patient‑reported outcomes may improve, controlled trials and comparative studies generally do not demonstrate a consistent localization advantage for implantable bone‑anchored systems over alternative approaches. The policy therefore highlights that improvement in localization with BAHA devices for SSD is not consistently supported by the evidence.

The policy emphasizes that implantable solutions entail surgical risks — for semi‑implantable middle ear aids these include potential loss of residual hearing, infection, facial paresis, taste disturbance, and other operative complications — and that these risks must be weighed against modest audiologic gains reported in trials. In short, surgical risk may outweigh modest audiologic benefit when external hearing aids provide similar outcomes.

Across trials and systematic reviews, enrolled patients were generally those who failed conservative treatments (including optimally fitted external hearing aids) and could not benefit from conventional amplification. Study reports and FDA trial populations commonly required preimplant audiologic documentation (unaided and best‑aided measures) as part of selection and evaluation. This context supports the expectation that candidates for implantation will have documented prior conservative therapy attempts.

The policy does not set a comprehensive list of absolute exclusions but notes that serious complications reported in some case series (for example, persistent facial nerve palsy after the Esteem device in a case series) and high rates of device replacement/explantation in cohorts raise concern. Therefore, although explicit absolute exclusions are not enumerated, significant complication rates and uncertain durability are cited as factors that may limit coverage for some patients.

The policy includes supplemental materials for reference but states clearly that inclusion of these materials does not constitute endorsement. The presence of supplemental documents or references is informational only and does not imply alignment with the evidence review conclusions or alter the policy’s coverage determinations.

The policy references external regulatory guidance and notes that CMS policy (for example, Chapter 16: General Exclusions from Coverage) may be relevant to specific device or service requests. Requests that conflict with applicable CMS general exclusions or payer rules could be subject to denial under those referenced exclusions, and reviewers should consider CMS guidance where applicable.

Semi‑ and fully implantable middle ear hearing aids are designated in the policy as investigational for indications where evidence is insufficient to demonstrate net health benefit. The policy therefore treats these systems as not established for routine coverage in many scenarios and cites the need for more robust long‑term data on durability, safety, and comparative efficacy relative to external hearing aids.

External bone‑conduction devices are associated with potential adverse effects such as pressure headaches and soreness when worn with headband or spectacle‑mounted systems. The policy indicates that when such external devices cause unacceptable adverse effects and implant candidacy criteria are not otherwise met, substitution with an implantable device is not supported unless documented and justified.

Some sections of the evidence synthesis do not include explicit 'not medically necessary' (NMN) labels, reflecting heterogeneity in outcomes and limited randomized data. The policy explicitly notes these evidence limitations and the absence of clear NMN designations in portions of the review, which affects the strength of coverage recommendations for certain indications.

The body of evidence does not support implantation solely to improve sound localization in patients with SSD. Comparative studies and systematic reviews report similar localization and speech‑in‑noise outcomes between bone‑anchored devices and acoustic CROS solutions; therefore SSD implantation for localization alone is not supported by the available evidence.

When only modest functional gains are expected and appropriately fitted external hearing aids provide similar audiologic outcomes, the policy advises caution about implanting devices that require surgery. In such cases, unless there is documented inability to use or intolerance of external aids, the surgical risks and potential for device complications argue against routine coverage for implantation where external aids produce comparable results.

The policy highlights that outcomes across studies are heterogeneous and that some evidence summaries do not include explicit NMN labels despite limited or mixed findings. This heterogeneity reduces confidence in broad application of positive findings and requires careful, individualized consideration when applying evidence to coverage decisions.

Several case series and cohort reports document notable rates of device replacement, explantation, and serious adverse events, and systematic reviews call for longer‑term data. Consequently, the policy concludes that evidence is insufficient on long‑term durability, safety, and comparative efficacy for certain indications, which warrants restrictive coverage in those contexts.

See the Codes table for the full list of CPT and HCPCS codes referenced in the policy. This section of the policy provides billing and reporting guidance and should be consulted when submitting claims for services related to bone‑conduction and middle ear devices.

Billing, CPT/HCPCS Codes, and Device Identifiers

Billing Codes (CPT/HCPCS/Misc)mixed

69710	Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
69711	Removal or repair 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
92622	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes

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Device regulatory identifiersmixed

DEN170009	FDA De Novo number for Bonebridge Bone Conduction Hearing Implant
K183373	FDA Premarket Approval number for Bonebridge Active Implantable Bone Conduction Hearing System
K172460	FDA Premarket Approval number for ADHEAR System
K240155	FDA Premarket Approval number for Cochlear Osia System

Pure-tone thresholds / device-specific audiologic thresholds

Device-specific bone-conduction PTA examplesExamples of device-specific bone-conduction pure-tone average (PTA) thresholds cited in policy: 45 dB (OBC and BP100), 55 dB (Intenso), 65 dB (Cordele II).

Bilateral symmetry requirementFor bilateral devices, symmetric conductive or mixed loss defined as interaural bone-conduction difference <10 dB on average (0.5,1,2,3 kHz) or <15 dB at individual frequencies per device labeling.

Frequencies used for PTAPTA measured at 0.5, 1, 2, and 3 kHz (and 4 kHz for some devices such as OBC and Ponto Pro) per device-specific indications.

Pure-tone air-conduction threshold limits (Table PG1)

Table PG1 — lower frequency limitsLower limits (dB) by frequency: 0.5 kHz = 30 dB; 1 kHz = 40 dB; 1.5 kHz = 45 dB; 2 kHz = 45 dB; 3 kHz = 50 dB; 4 kHz = 50 dB.

Table PG1 — upper frequency limitsUpper limits (dB) by frequency: 0.5 kHz = 65 dB; 1 kHz = 75 dB; 1.5 kHz = 80 dB; 2 kHz = 80 dB; 3 kHz = 85 dB; 4 kHz = 85 dB.

Use in device candidacyAir-conduction thresholds in Table PG1 are referenced as limits for semi-implantable device recipient selection (e.g., Vibrant Soundbridge package insert).

No explicit codes in this sectionmixed

No codes listed

See Codes table (duplicate mapping)mixed

69710	Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
69711	Removal or repair 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
92622	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes

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Prior Authorization, Documentation & Operational Requirements

Prior Authorization

Prior approval required — prior approval is required for all procedure codes/requests except those for middle ear devices

Prior approval is required for all requests except middle ear procedures. Refer to the payer authorization table to determine applicable prior approval requirements for the specific CPT/HCPCS code(s). Device-specific regulatory and labeling requirements (e.g., FDA-cleared age limits or PMA/De Novo identifiers) may affect authorization decisions and must be provided with the request.

Prior approval required for all procedure codes/requests except middle ear codes
Include FDA device identifiers or clearing/approval documentation when applicable (see FDA summaries)

Prior Authorization

Prior authorization and device-specific indication requirements — device-specific age and indication documentation expectations

Provide device-specific indication and age documentation consistent with the device labeling. For example, submit supporting documentation if a device has an age restriction (e.g., Osia™2 cleared for specific pediatric ages) or other device-specific indications.

Document device model, manufacturer, and FDA clearance/approval (510(k), PMA, or De Novo number when available)
If device labeling limits use by age or indication, include documentation demonstrating patient meets those criteria

Documentation Required

Preauthorization requirements — document diagnosis, prior hearing aid trials or softband testing where applicable

Preauthorization requests must include the clinical indication, relevant diagnostic testing, prior conservative management, and trial information when applicable. Expected documentation includes the audiologic testing described below, prior hearing aid trials or softband testing, and evidence of patient inability to use or dissatisfaction with external aids when relevant.

Clearly state the primary diagnosis and laterality
Include prior conservative treatments and outcomes (see guidelines below)
Provide documentation of prior appropriately fitted external hearing aid trials or softband trials if applicable

Documentation Required

Prior authorization evidence expectations — expected follow-up length and preferred evidence level

Preauthorization evidence should include baseline and follow-up audiograms (unaided and best-aided conditions), speech recognition/word recognition scores, and at least 1 year of follow-up data when available to observe outcomes and adverse events. Include patient-reported outcome measures where available (e.g., SSQ12-B, GBI).

Unaided and best-aided preimplant audiometry (pure-tone averages and thresholds)
Pre- and post-implant speech recognition/word recognition scores with test conditions specified
At least 12 months of follow-up data preferred for outcome assessment
Include PROMs such as SSQ12-B or GBI when available

Documentation Required

Prior authorization: inability to use or dissatisfaction with external aids — document inability or dissatisfaction and comparative testing

When the request is based on inability to use or dissatisfaction with external aids, document the nature of the inability or dissatisfaction and provide comparative testing demonstrating inadequate benefit from optimally fitted external hearing aids (or documented trials with alternative devices such as CROS or bone-conduction external aids).

Describe specific reasons external aids are not tolerated or are ineffective (e.g., chronic otitis externa, ear canal atresia, discomfort)
Provide documentation of comparative testing between external aids and implantable options (best-aided preimplant condition vs unaided and postimplant conditions)

Step Therapy

Prior conservative treatment and audiometric documentation — document failure of conservative treatments

Document failure of conservative treatments prior to implant consideration. For sensorineural or conductive indications, this includes trials with optimally fitted external air-conduction hearing aids, earmolds, or other nonimplantable alternatives. Include dates, duration, and fitting validation that the aids were optimally programmed and worn.

Record duration and outcome of optimally fitted external hearing aid trials
Include evidence of counseling and non-surgical management attempts
For pediatric candidates, document softband or preoperative external device trials when applicable

Documentation Required

Preimplant audiologic documentation — require unaided and best-aided comparisons

Preimplant audiologic documentation must include unaided and best-aided pure-tone averages (PTA), air- and bone-conduction thresholds, aided sound-field thresholds, speech reception thresholds, and word recognition scores. Indicate whether comparisons are to unaided or best-aided preimplant conditions and provide detailed test conditions.

Unaided PTA (500, 1000, 2000, 4000 Hz) and best-aided PTA
Aided sound-field thresholds and speech reception thresholds
Word recognition / speech recognition scores with test conditions and pre/post comparisons

Prior Authorization

Prior authorization considerations — CMS policy and position statements inform decisions

Consider CMS policy and general exclusions when making coverage decisions. Requests conflicting with Medicare/Medicaid general exclusions or local coverage determinations may be denied. Also consider payer administrative rules regarding coding and authorization when reviewing requests.

Reference CMS General Exclusions (Medicare Benefit Policy Manual, Chapter 16) for coverage context
Ensure requests align with current payer authorization rules and local coverage determinations

Billing Rule

Prior authorization and affected codes — CPT/HCPCS codes listed; payer admin rules govern approvals

Use the appropriate CPT and HCPCS codes when submitting requests and claims. Claims billed without the appropriate codes listed may be denied. Provide the code(s) on the prior authorization request and include operative/procedure notes and device details.

Common CPT codes: 69710, 69711, 69714, 69716, 69717, 69719, 69729, 69730, 69799, 92622, 92623
HCPCS codes: L8690, L8691, L8692, L8693, L8694; other relevant codes include 0955T, S2230, V5095

Denial Risk

Risk factors for denial — inadequate skull quality or caregiver inability to maintain hygiene

Certain clinical or social factors may increase the risk of denial. Inadequate skull bone quality or thickness for osseointegration, inability of the patient or caregiver to perform necessary hygiene to prevent infection, evidence of device abuse or neglect, or lack of objective documentation of device malfunction are examples of conditions that may lead to denial.

Document skull bone quality/thickness when implant stability is a concern
For pediatric or dependent patients, document caregiver ability to manage percutaneous hygiene
Do not approve replacement if device loss, abuse, or neglect is suspected without supporting justification

Documentation Required

Evidence requirements — lack of prospective comparative trials or RCTs may affect approval

The evidence base has limitations: comparative RCTs are few, many studies are small or single-arm, and high heterogeneity exists in adverse event reporting. Studies with duplicative or overlapping populations may be disregarded when assessing aggregate evidence. Provide the best available comparative data when possible.

Prefer prospective comparative trials (RCTs when available) or prospective observational comparative studies
Single-arm studies may inform longer-term safety but are lower-level evidence
Exclude or note studies with duplicative/overlapping populations in evidence summaries

Documentation Required

Studies with duplicative or overlapping populations — device evidence overlap exclusion

When literature submitted contains overlapping cohorts or duplicative populations, clearly identify overlap and avoid double-counting outcomes. The reviewer may discount or exclude overlapping data when determining sufficiency of evidence.

Provide study identifiers and enrollment dates to help reviewers assess for overlapping populations
If submitting multiple studies from the same center, clarify whether patient cohorts overlap

Denial Risk

Safety concerns may trigger denial — high/heterogeneous adverse event rates (skin reactions, implant loss)

Safety concerns that may trigger denial include high rates of adverse skin reactions, implant loss, frequent explantations or revisions, serious device-related complications (e.g., facial paresis), or heterogeneous adverse-event profiles that suggest unacceptable risk. Provide adverse event rates and follow-up duration.

Report incidence of skin complications (e.g., Holgers grade 2–4) and implant loss rates
Document frequency and timing of explantations or revisions and any serious adverse events

Denial Risk

Device malfunction/explantation risk — documented explantations for device malfunction may influence coverage

Document any prior device malfunction, explantation, or replacement events with objective evidence. High rates of replacement or explantation for malfunction, or documented device failures, may influence coverage decisions for replacement devices.

Provide objective documentation from an audiologist or device manufacturer that the device is non-repairable
Include dates of implantation, warranty information, and evidence device was used until malfunction

Denial Risk

Durability and complication risk — high replacement/explantation and serious complications reported

Durability concerns and complication risks should be described in preauthorization materials. Longitudinal data on replacement and explantation rates, as well as serious complications, inform medical necessity determinations.

Include long-term follow-up data when available (replacement/explantation rates and timing)
Describe serious complications and resolution status at last follow-up

Note

CMS exclusions referenced — potential denial if request conflicts with CMS general exclusions

Provide citations to relevant regulatory and policy references submitted with the request. CMS manuals and FDA regulatory summaries are commonly used references when evaluating coverage and exclusions and should be included when relevant.

CMS Medicare Benefit Policy Manual, Chapter 16 (general exclusions)
FDA device summaries and 510(k)/PMA/De Novo documentation as applicable

Documentation Required

Required pre-implantation documentation — skull bone quality/thickness and caregiver ability to manage hygiene

Required pre-implantation documentation includes skull bone assessment (quality and thickness), caregiver ability to perform hygiene for percutaneous devices, operative planning details, and device warranty/repair status when requesting replacements.

Skull bone quality/thickness assessment (imaging or surgeon assessment)
Caregiver or patient capability to maintain percutaneous site hygiene
Manufacturer warranty information and documentation of device non-repairability for replacements

Documentation Required

At least 1 year of follow-up is considered necessary to fully observe outcomes

At least 1 year of follow-up is considered necessary to observe outcomes and many authorization decisions will require reporting of outcomes at or beyond this interval when available.

Provide 12 months of follow-up data when available for safety and effectiveness assessment
Shorter follow-up may be acceptable in premarket or limited clinical-context requests but must be justified

Documentation Required

Preimplantation audiologic and indication documentation — baseline aided performance and indication required

Preimplantation audiologic and indication documentation must demonstrate the baseline functional limitation and the rationale for implantation. Provide unaided and best-aided performance, evidence of limited benefit from optimally fitted external aids, and objective measures supporting the chosen indication.

Unaided vs best-aided comparisons and documentation showing insufficient benefit from best-aided condition
Objective measures such as PTA, aided thresholds, and word recognition scores supporting implantation

Documentation Required

Required outcome documentation — report word recognition, PROMs (SSQ12-B, GBI), and follow-up durations

Required outcome documentation for preauthorization and post-implant follow-up should include word recognition scores, speech reception thresholds, PROMs (e.g., SSQ12-B, GBI), adverse events, and duration of follow-up.

Report word recognition/speech recognition results pre- and post-implant with test conditions
Include PROMs (SSQ12-B, GBI) and a summary of adverse events
Provide length of follow-up for outcome assessments

Note

Documentation references — CMS manuals and fact sheets cited for coverage/exclusion context

When submitting requests, include literature citations, regulatory summaries, and device manuals as supporting documentation. Reference CMS and FDA materials where applicable to support coverage and exclusion assessments.

Attach relevant peer-reviewed studies, systematic reviews, and registries if available
Include FDA 510(k)/PMA/De Novo summaries and CMS references when relevant

Step Therapy

Step therapy expectations — document trials of external air-conduction hearing aids or alternatives

Step therapy expectations: document trials of external air-conduction hearing aids or appropriate nonimplantable alternatives before implantation, unless there is clear contraindication (e.g., congenital aural atresia, absent external canal, medical contraindication to external aids).

Document duration and adequacy of external AC hearing aid trials
If step therapy is bypassed, provide specific clinical justification

Step Therapy

Comparator/step consideration — external hearing aids as primary comparator; document trials/limitations

Comparator/step consideration: external hearing aids (AC) are the primary comparator. When available, provide best-aided preimplant performance to allow comparison with anticipated implant benefit.

Provide best-aided preimplant audiologic measures as the comparator
If comparing to CROS or other devices, include device-specific trial documentation

Step Therapy

Therapy is considered as an alternative to conventional hearing aids — document trial of nonimplantable options

Therapy alternatives: nonimplantable therapies (optimally fitted hearing aids, CROS, bone-conduction external devices, or assistive listening devices) should be trialed and documented as reasonable alternatives prior to approval for implantable devices, unless contraindicated.

Document trials of nonimplantable alternatives and reasons for failure or intolerance
Include objective measures demonstrating inadequate benefit from alternatives

Step Therapy

Trial of external hearing aids recommended — document prior adequate trials

Trial of external hearing aids is recommended and expected unless clinically contraindicated. Documentation must demonstrate optimally fitted trials with objective verification of benefit (or lack thereof).

Evidence of optimal fitting, verification (real-ear or equivalent), and duration of use for external aids
If using softband trials in children, provide preimplant softband audiologic data

Step Therapy

Trial of optimally fitted hearing aids — documentation of optimally fitted aid trials expected

Trial of optimally fitted hearing aids: provide documentation that external hearing aids were fitted and verified to be optimal (real-ear measures or equivalent) and that the patient used them for an adequate trial period without satisfactory benefit.

Real-ear or objective verification of fitting when available
Duration and adherence information for the trial period

Step Therapy

Trial of external hearing aids — consider documented best-fit trials before implant

Trial of external hearing aids: record dates, device types, fitting verification, and outcome measures showing insufficient benefit to justify implant when applicable. If no explicit step-therapy pathway exists in the member’s benefit design, provide clinical justification for proceeding to implant.

List device make/model, fitting dates, and documented outcomes
If the benefit plan has no explicit step therapy requirement, note that step therapy may still be clinically expected

Clinical Background and Definitions

Bone‑conduction and bone‑anchored hearing devices provide alternatives to conventional air‑conduction hearing aids for patients with conductive or mixed hearing loss and, in selected cases, for unilateral sensorineural hearing loss using contralateral routing of signal (CROS). Implantable systems (percutaneous or transcutaneous) transmit sound via the skull to the cochlea after osseointegration, while semi‑ and fully implantable middle ear devices transduce sound directly to middle ear structures and are intended primarily for sensorineural loss. The policy frames these device classes by indication, expected functional gains, and the balance of surgical risk versus benefit.

Bone-anchored hearing aid (BAHA) — definition

DefinitionBone-anchored hearing aid (BAHA): a system that uses a percutaneous or transcutaneous connection to a sound processor to transmit sound via bone conduction for conductive, mixed, or unilateral sensorineural hearing loss.

MechanismTransmits vibrations through the skull to the cochlea via an implant (titanium) coupled to the temporal bone, often using an external sound processor.

Indications (general)Used for patients with conductive or mixed hearing loss and, when used with CROS, for selected unilateral sensorineural hearing loss (SSD).

Semi- or fully implantable middle ear hearing aid — definition

DefinitionSemi- or fully implantable middle ear hearing aid: an implanted device that detects sound and transduces signals directly to middle ear structures (ossicles) as an alternative to external acoustic hearing aids.

Semi-implantable exampleSemi-implantable devices (e.g., Vibrant Soundbridge) have an implanted transducer coupled to ossicles or windows and may include external components per labeling.

Fully implantable exampleFully implantable systems (e.g., Esteem, Carina) are entirely implanted under the skin and provide amplification without external components; FDA trial data available for Esteem.

Hearing loss categories — conductive, sensorineural, mixed; degree definitions

CategoriesHearing loss categorized as conductive, sensorineural, or mixed; can be unilateral or bilateral.

Degree definitions (PTA)Degrees by pure-tone average: mild 20–40 dB; moderate 40–60 dB; severe 60–80 dB; profound ≥80 dB.

Normal hearing thresholdNormal hearing is detection of sound at or below 20 dB.

Osseointegration — biologic integration and typical timeframe

DefinitionOsseointegration: biologic integration of titanium implant with living bone that provides stable coupling for bone-anchored hearing systems.

Typical timeframeIntegration typically occurs over approximately 3 to 6 months to achieve stable implant coupling.

Clinical relevanceAdequate osseointegration is required for long-term implant stability and function; skull bone quality/thickness should be assessed preimplantation.

Percutaneous BAHA — definition note

DefinitionPercutaneous BAHA: a bone-anchored hearing system that uses a percutaneous abutment protruding through the skin from a titanium implant anchored in temporal bone to couple an external sound processor to the skull.

CharacteristicPercutaneous systems provide direct transmission of vibrations without intervening skin, allowing lower energy transmission than external bone-conduction devices.

ConsiderationsRequires ongoing skin care/hygiene at the abutment site to reduce infection and soft tissue complications.

Transcutaneous BAHA — partially implantable transcutaneous BAHA definition

DefinitionTranscutaneous BAHA (partially implantable transcutaneous): an implanted magnetic component placed in a shallow bone bed that is magnetically coupled through intact skin to an external sound processor, transmitting acoustic energy transcutaneously.

CharacteristicNo percutaneous abutment is required; skin thickness may be reduced to ~4–5 mm over the implant to facilitate transmission.

BenefitReduces need for skin-penetrating abutment and associated periabutment care, but still requires assessment of skull bone anatomy and surgical considerations.

SSD (single-sided deafness) — definition

DefinitionSingle-sided deafness (SSD): unilateral sensorineural hearing loss in which one ear has minimal to moderate hearing while the other has significant sensorineural hearing loss, causing difficulty hearing on the impaired side.

Clinical impactPatients with SSD often have difficulty understanding conversation on the impaired side, especially in background noise.

Treatment contextSSD may be managed with CROS strategies or implantable/transcutaneous BAHA systems as alternatives to AC hearing aids.

CROS — contralateral routing of signal definition

DefinitionCROS (contralateral routing of signal): a system that transmits sound from the affected (poorer) ear to the normal or less affected ear, typically via microphone and transmitter to improve audibility on the impaired side.

UsageUsed for unilateral sensorineural hearing loss (SSD) when routing to the better ear provides functional improvement compared with unaided condition.

ComparatorsCROS solutions include AC CROS hearing aids and bone-conduction systems using CROS principles.

Functional gain — definition

DefinitionFunctional gain: the difference in sound-field thresholds (dB) between unaided and aided conditions, indicating the functional benefit from an amplification device.

ExamplesReported functional gain examples: Soundbridge ~14.1 dB; Soundtec ~7.9 dB (modest improvements).

InterpretationMagnitude of functional gain may be clinically meaningful depending on baseline degree of hearing loss (e.g., moving thresholds into normal range).

Holgers Classification System — skin reaction grading

DefinitionHolgers Classification System: a grading scale for soft tissue reactions around percutaneous BAHA implants (grade 0 = no reaction; grade 2 = red and moist tissue; grade 3 = granulation tissue; grade 4 = removal of implant necessary due to infection).

Use in studiesUsed in systematic reviews and cohort studies to report incidence of skin reactions and compare surgical techniques (punch, linear incision, Weber).

Reported rangesHolgers grade 2–4 reactions reported across studies ranged widely (e.g., 2.4%–38.1%).

Functional gain (duplicate definition entry)

Definition (duplicate)Functional gain: difference in sound-field thresholds (dB) indicating the functional benefit from an amplification device (duplicate entry).

Measurement contextReported in trials and systematic reviews to quantify benefit of semi-/fully implantable devices versus unaided or aided conditions.

Clinical noteFunctional gain values vary by device and study; interpret in context of speech recognition and patient-reported outcomes.

Speech recognition tests referenced — definitions of tests used

Speech Perception in NoiseA test used to assess speech recognition in noisy environments referenced in device trials and reviews.

Northwestern University 6 testA 50-item word list used to assess word recognition in quiet and noise; referenced in comparative device studies.

Use in outcomesThese tests are used to report word recognition and speech reception outcomes in regulatory trials and observational studies.

Semi-implantable middle ear hearing aid — additional definition

Additional semi-implantable definitionSemi-implantable middle ear hearing aid: device with an implanted transducer coupled to middle ear structures (e.g., Vibrant Soundbridge) that may have external components or coupling to ossicles/windows.

Recipient selectionPackage insert criteria include pure-tone AC thresholds within Table PG1 limits, word recognition >50%, normal middle ear anatomy, and experience with appropriately fitted hearing aids.

Off-label use noteSome semi-implantable devices have been studied off-label for conductive or mixed losses with alternative coupling (e.g., round or oval window).

Fully implantable middle ear hearing aid — definition with examples

DefinitionFully implantable middle ear hearing aid: a hearing system entirely implanted under the skin intended to provide amplification without external components (examples: Esteem, Carina).

Regulatory/trial contextFDA approval of Esteem based on prospective multicenter trial (60 patients) showing mean SRT improvement ~11.4 dB at 10 months; adverse events included taste disturbance and facial paresis among others.

Evidence noteSystematic reviews report improved sound-field thresholds from unaided to aided conditions, but comparative data versus conventional hearing aids are mixed and studies are small.

Bone Conduction Hearing Devices (BCHD) — definition

DefinitionBone Conduction Hearing Devices (BCHD): devices that transmit sound via bone conduction including percutaneous and transcutaneous implantable systems, semi-implantable middle ear implants, bone conduction oral appliances, and scalp-worn devices used to treat conductive and mixed hearing loss and select SSD.

ScopeEncompasses implantable or externally coupled devices that rehabilitate conductive, mixed, or single-sided sensorineural hearing loss.

ExamplesIncludes percutaneous BAHA, transcutaneous magnetic BAHA, Bonebridge, Osia, Ponto, and other FDA-cleared systems referenced in policy.

Consensus statement — definition/context

Definition/roleConsensus statement: an expert guidance document (e.g., 2022 consensus) that provides information on patient education and technical aspects of device placement but does not give definitive recommendations on which patients will most benefit from implantable middle ear hearing aids over other devices.

Use in policyConsensus statements and professional society position statements (e.g., AAO-HNS) are used to inform device-appropriate populations and implementation considerations.

LimitationsConsensus statements may not substitute for high-level comparative evidence and are advisory rather than prescriptive for coverage determinations.

Bone conduction devices / active middle ear implants — definitional summary

Summary definitionBone conduction devices and active middle ear implants are implantable or externally coupled systems that transmit sound via bone conduction or active middle ear mechanisms to rehabilitate conductive, mixed, or single-sided sensorineural hearing loss.

IncludesPercutaneous and transcutaneous bone-anchored systems, partially and fully implantable middle ear devices, and related external bone-conduction prostheses.

Clinical contextSelection depends on type/degree of hearing loss, anatomy, prior trials of external aids, device-specific labeling, and patient/caregiver ability to manage devices and possible complications.

Auditory osseointegrated device (HCPCS L8690) — coding definition

HCPCS L8690 definitionAuditory osseointegrated device (HCPCS L8690): includes all internal and external components of an auditory osseointegrated device as listed in the HCPCS codes.

Related HCPCS entriesOther related HCPCS codes (L8691–L8694) describe external sound processors, headband/body-worn processors, abutment replacements, and transducer replacements.

Coding useL8690 is used to report the auditory osseointegrated device including internal and external components for billing and coverage purposes.

Policy Revision History

2025-06interim_review_and_policy_revisionLatest

Policy underwent an interim review and revision in June 2025; header review date updated to June 2025.

2025-02annual_review_and_revision

Policy revised following the February 2025 annual review (document lists revision in February 2025).

2015-04-01original_effective_date

Policy originally became effective April 1, 2015.