ModifiedColorado Rocky Mountain Health PlansPolicy CS052.U

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

Medical policy governing medical necessity and coverage for wearable air-conduction hearing aids, bone-anchored devices (implantable and non-implantable), semi-implantable electromagnetic hearing aids, and related devices for members of Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS052.U

Change TypeCodes updatedstate applicability edits

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionUse the updated CPT/technology codes (0951T–0955T) when submitting prior authorization requests and confirm device-specific selection criteria and audiometric documentation.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable CPT codes to reflect quarterly edits; added 0951T, 0952T, 0953T, 0954T, and 0955T.

Added language to indicate this Medical Policy does not apply to the state of Nebraska; refer to the state-specific policy version.

Removed content/language pertaining to the state of Louisiana.

5device categories addressed

20+codes listed

5new CPT codes added

15+

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.

Coverage Criteria and Device Status

Covered Devices

Covered when used according to FDA labeled indications and when the individual is an appropriate candidate.

Covered device types: Wearable air-conduction hearing aids are proven and medically necessary for correction of hearing impairment; when an individual is not a candidate for air-conduction hearing aids, the following are proven and medically necessary when used per FDA labeling: bilateral fully or partially implantable bone-anchored hearing aids for conductive or mixed hearing loss in both ears; bilateral or unilateral non‑implantable bone conduction hearing aids using a headband or adhesive; semi‑implantable electromagnetic hearing aids for sensorineural hearing loss; unilateral fully or partially implantable bone-anchored hearing aids for conductive or mixed hearing loss; unilateral fully or partially implantable bone-anchored hearing aids for sensorineural hearing loss.

Uses FDA labeled indications

Unproven / Not Medically Necessary Devices

Not medically necessary / unproven devices

Unproven devices: The following are unproven and not medically necessary due to insufficient evidence of efficacy: intraoral bone conduction hearing aids; laser or light‑based hearing aids; totally implanted middle ear hearing systems.

Equipment upgrades are treated as new services

Implied coverage criteria and clinical pathway

Coverage-relevant clinical considerations and implied criteria from evidence:

Trial and indication: Candidate should have conductive or mixed hearing loss or single‑sided deafness where bone conduction devices are clinically indicated; a non‑implantable trial (headband/softband/adhesive) is reasonable prior to implantation, particularly in children.

Supported by systematic reviews and cohort studies; trial-to-implant pathway recommended

Device types with evidence of benefit: Evidence demonstrates audiologic and subjective benefit for non‑implantable BCHAs (headband/adhesive), semi‑implantable electromagnetic devices (e.g., Vibrant Soundbridge), percutaneous BAHA, and transcutaneous magnetic coupling systems (e.g., BAHA Attract, Bonebridge, Osia), although comparative superiority among devices is uncertain.

Quality of evidence varies; some devices have low-to-very-low comparative evidence

Age and timing considerations: Children may use non‑implantable devices until the temporal bone matures; implantation may be considered if a trial demonstrates audiologic and/or quality‑of‑life benefit.

Described in pediatric systematic reviews and cohort studies

Coverage criteria for implantable and bone conduction hearing devices

Covered when ALL of the following are met (per device labeling and clinical guidance):

Device-specific selection criteria: Patient meets the device‑specific selection criteria described in FDA professional labeling or professional society guidance (examples include Vibrant Soundbridge audiologic ranges and word recognition score; BAHA indications for conductive/mixed loss or single‑sided deafness).see coding.thresholds

Document objective audiometric testing and prior conservative treatments where applicable

Appropriate clinical indications: Indication includes conductive hearing loss, mixed hearing loss, or single‑sided deafness when the patient cannot use or does not benefit from conventional amplification.

AAO‑HNS supports active middle ear implants and bone conduction devices in appropriately selected adults

Qualified operator: Procedure performed by a qualified otolaryngologist/head and neck surgeon in accordance with AAO‑HNS recommendations and FDA labeling.

Device-specific covered indications

Covered when ALL of the following device-specific FDA indications are met (examples captured below):

Age requirement: Patient meets the device‑specific minimum age per FDA labeling (examples: Sophono/Otomag magnetic implant and BAHA early clearances: ≥5 years for some implants; Bonebridge and Osia/Osia2: ≥12 years; Vibrant Soundbridge and Maxum: adults ≥18 years; Earlens: adult labeling varies).age per device

See device‑specific FDA labeling for exact age limits

Hearing threshold criteria: Patient's pure tone average (PTA) bone‑conduction or air‑conduction thresholds meet device‑specific limits (examples: many bone conduction devices require BC PTA ≤45 dB HL; Osia labeling indicates BC PTA up to ≤55 dB HL; ADHEAR BC ≤25 dB HL; SSD candidacy requires AC PTA in the hearing ear ≤20 dB HL).PTA values per device (commonly measured at 0.5, 1, 2, 3 kHz)

Measure PTA at frequencies specified in device labeling; some devices include 4 kHz

Symmetry criteria for bilateral fitting:

The following device categories are considered unproven and not medically necessary due to insufficient evidence of efficacy: intraoral bone conduction hearing aids, laser or light-based hearing aids, and totally implanted middle ear hearing systems. This determination is based on the limited quality of available studies, small sample sizes, short follow-up, and lack of randomized, controlled comparative data.

The SoundBite™ intraoral system is no longer manufactured. Sonitus Medical, Inc. filed for bankruptcy in 2015 and production of the SoundBite Hearing System ceased; therefore this device is unavailable as a coverage option.

Available studies for intraoral bone conduction hearing aids are of insufficient quality to support their use for treating hearing loss. Evidence limitations include small study populations, short follow-up, lack of randomization, and absent appropriate control groups.

Evidence for totally implanted middle ear hearing systems is limited and of insufficient quality to establish consistent efficacy. Identified studies are predominantly single-arm or retrospective, report conflicting findings, and note device-related adverse events and fitting/feedback issues; higher-quality comparative trials are needed before routine coverage can be supported.

Devices that have ceased production or are no longer manufactured (for example, the SoundBite system) may not be available for clinical use. Continued coverage of a device that is no longer produced depends on product availability and clinical appropriateness; unavailable products cannot be considered an option for new requests.

This Medical Policy version does not apply to the state of Nebraska. Refer to the state-specific policy version for coverage determinations and applicable requirements in Nebraska.

Totally implanted middle ear hearing systems are listed in this policy as unproven and not medically necessary due to insufficient evidence supporting their efficacy for treating hearing loss.

For devices such as Bonebridge and similar partially implantable transcutaneous systems, the evidence base is low or very-low-quality and lacks randomized controlled trials. The available studies have high risk of bias and provide only indirect or contradictory comparative data, limiting confidence in claims of superiority or defining optimal patient populations.

Several devices or indications are supported only by low-quality, noncomparative evidence (for example, intraoral bone conduction devices and some fully implanted middle ear systems). Because of study limitations—including small samples, single-arm designs, and short follow-up—these devices lack robust comparative data to justify broad coverage.

This section includes informational listings of device approvals or manufacturer information (for example, the FDA approval documentation for the Esteem® device). Such informational entries do not in themselves denote coverage and may be listed without an explicit medically necessary or not medically necessary determination.

Billing Codes and Device References

Bone Anchored Hearing Aids (BAHA) and Fitting/Testing CPTCPT

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.
92590	Hearing aid examination and selection; monaural.
92591	Hearing aid examination and selection; binaural.
92592	Hearing aid check; monaural.

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Totally Implantable Middle Ear Hearing Implants (CPT/Unlisted)CPT

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.
0953T	Totally implantable active middle ear hearing implant; revision or replacement, without mastoidectomy and replacement of sound processor.
0954T	Totally implantable active middle ear hearing implant; replacement of sound processor only, with attachment to existing transducers.
0955T	Totally implantable active middle ear hearing implant; removal, including removal of sound processor and all implant components.

BAHA HCPCS/CPT and Fitting/Testing HCPCSmixed

L8690	Auditory osseointegrated device, includes all internal and external components.
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.
S0618	Audiometry for hearing aid evaluation to determine the level and degree of hearing loss.
V5010	Assessment for hearing aid.
V5011	Fitting/orientation/checking of hearing aid.
V5014	Repair/modification of a hearing aid.
V5020	Conformity Evaluation.
V5264	Ear mold/insert, not disposable, any type.

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Wearable Hearing Aids and Semi-Implantable HCPCS/V-codesHCPCS

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.
V5070	Glasses, air conduction.
V5080	Glasses, bone conduction.
V5100	Hearing aid, bilateral, body worn.
V5211	Hearing aid, contralateral routing system, binaural, ITE/ITE.

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Codes referenced or impliedmixed

none specified

No explicit CPT/HCPCS/ICD-10 codes listed in this document segment.

FDA 510(k)/PMA reference numbers and device clearances citedmixed

K984162	FDA documentation reference for Branemark/BAHA clearance (1995)
K090720	BAHA BP100 510(k) information (2009)
K080363	BAHA Cordelle II 510(k) information
K992872	BAHA Cordelle II earlier 510(k)
K081606	BAHA Intenso 510(k) information (2008)
K042017	BAHA Divino 510(k) information (2004)
K100360	BAHA auditory osseointegrated implant system 510(k) (2010)
K082108	OBC Bone Anchored Hearing Aid System 510(k) (2008)
K121228	Ponto Bone Anchored Hearing System 510(k) (2012)
P990052	Vibrant Soundbridge PMA reference (Vibrant approval)

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FDA 510(k) referencesmixed

K211640

Ponto 5 Mini FDA 510(k) reference

Osia system FDA referencesmixed

K190589	Osia System 510(k)
K191921	Osia 2 System 510(k)

Non-implantable device FDA referencesmixed

K172460

ADHEAR System 510(k)

Applicable CPT/Technology Codes (updated)CPT

0951T	Added CPT/Technology code (as listed in policy updates)
0952T	Added CPT/Technology code (as listed in policy updates)
0953T	Added CPT/Technology code (as listed in policy updates)
0954T	Added CPT/Technology code (as listed in policy updates)
0955T	Added CPT/Technology code (as listed in policy updates)

Degree of hearing loss (dBHL categories)

Normal-10 to 15 dBHL

Slight16 to 25 dBHL

Mild26 to 40 dBHL

Moderate41 to 55 dBHL

Moderately severe56 to 70 dBHL

Severe

Authorization, Documentation, and Prior Authorization Guidance

Prior Authorization

Prior Authorization and Documentation Requirements

Authorization is required for the procedures and device implantations listed in the applicable codes section. Prior authorization requests must use the updated CPT/HCPCS codes in this policy and confirm that the member meets device-specific FDA-labeled selection criteria and audiometric thresholds. Medical records and supporting audiology documentation may be requested to determine whether the clinical criteria are satisfied; absence of required documentation may result in denial.

Applicable procedure and implant codes must be referenced on the prior authorization request (use the updated codes in this policy).
Prior authorization must confirm device-specific indications per FDA professional labeling (age, PTA BC/AC thresholds, word recognition scores, middle ear anatomy, prior hearing aid experience where required).
Audiometric evidence required: pure tone average (PTA) bone conduction and/or air conduction thresholds at specified frequencies, and word recognition scores as applicable to the device.
Medical records documentation may be required to assess coverage; lack of documentation may lead to denial.

Clinical Background and Evidence Summary

Wearable air‑conduction hearing aids remain the standard treatment for hearing loss that cannot be medically or surgically corrected. When conventional air‑conduction amplification is not possible or not tolerated, bone‑conduction options (non‑implantable or implantable) and semi‑implantable electromagnetic devices are considered based on device labeling, patient-specific audiometric criteria, and evidence of benefit.

Key Terms and Device Definitions

Conductive Hearing Loss — Definition

DefinitionOccurs when sound is not conducted efficiently through the outer ear canal to the eardrum and the ossicles of the middle ear

Clinical effectUsually involves reduction in sound level or the ability to hear faint sounds

TreatabilityCan often be corrected medically or surgically

Degree of Hearing Loss / Sensorineural Hearing Loss

Degree rangesNormal (-10 to 15 dBHL); Slight (16–25); Mild (26–40); Moderate (41–55); Moderately severe (56–70); Severe (71–90); Profound (≥91)

Sensorineural HL definitionDamage to the inner ear (cochlea) or nerve pathways; usually not medically or surgically correctable

Policy Changes and History

2026-04-01template_updateLatest

Template update and removal of content/language pertaining to the state of Louisiana.

2025-11-01state_applicability_update

Added language excluding Nebraska from this Medical Policy version; refer to the state-specific policy version for Nebraska.

2025-08-01codes_update

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS052.U

Change TypeCodes updatedstate applicability edits

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionUse the updated CPT/technology codes (0951T–0955T) when submitting prior authorization requests and confirm device-specific selection criteria and audiometric documentation.

SourceLink

On This Page

Adhere to FDA restrictions and professional society guidance

For bilateral implantation, interaural bone‑conduction threshold difference must meet device definitions (commonly <10 dB average across specified frequencies or <15 dB at individual frequencies).

<10 dB average or <15 dB individual

Applies to bilateral candidacy per FDA clearances

SSD or CROS alternative: For single‑sided deafness (profound sensorineural deafness in one ear) the contralateral ear must have normal hearing (AC PTA ≤20 dB HL at 0.5, 1, 2 and 3 kHz) and the patient cannot or will not use an AC CROS, to be eligible for a bone conduction device indicated for SSD.AC PTA ≤20 dB HL in hearing ear

Described in BAHA, Bonebridge, Osia device labeling

Conservative therapy recommendation: Prior to implantation, it is recommended the individual have experience with appropriately fitted air‑conduction or bone‑conduction hearing aids when indicated by device labeling.trial of non‑surgical amplification when applicable

FDA and professional guidance recommend prior trial for some devices

Profound91 dBHL or more

Vibrant Soundbridge audiometric selection thresholds

Age requirementAdults aged 18 or older (Vibrant Soundbridge)

Word recognition50% or better using recorded material

500 Hz threshold30-65 dB (AC)

1000 Hz threshold40-75 dB (AC)

1500–4000 Hz thresholds1500: 45-80 dB; 2000: 45-80 dB; 3000: 50-85 dB; 4000: 50-85 dB (AC)

BAHA bilateral implantation symmetry requirement

Bilateral symmetry definitionLess than 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz)

Alternate per-frequency thresholdLess than 15 dB difference at individual frequencies

ApplicationApplies to bilateral implantation candidacy for BAHA/Bonebridge/Osia systems

BAHA SSD normal hearing definition

Definition of normal hearing (SSD use)PTA air-conduction threshold equal to or better than 20 dB measured at 0.5, 1, 2 and 3 kHz

ContextRequired contralateral hearing standard for BAHA use in single-sided deafness

Intended benefitIndication intended to improve speech recognition for SSD patients

PTA bone-conduction and air-conduction thresholds — Device-specific values

Common BC PTA limit (many devices)Bone-conduction PTA ≤ 45 dB HL (measured at 0.5, 1, 2, and 3 kHz)

Osia/Osia2 requirementBC PTA better than or equal to 55 dB HL (measured at 0.5,1,2,3 kHz)

ADHEAR requirement (non-implantable)BC PTA better than or equal to 25 dB HL (measured at 0.5,1,2,3 kHz)

Hearing ear AC for SSDAC PTA of the hearing ear ≤ 20 dB HL (0.5,1,2,3 kHz)

Device-specific superpower rangesSome processors specified up to 65 dB HL or higher for power models (e.g., Cordelle II, Baha 5 SuperPower)

Documentation Required

Prior Trial of Non‑Implantable BCHA Recommended

Trialing a non-implantable bone conduction hearing aid (BCHA) on a headband, softband, or adhesive is recommended—particularly for children and for patients being considered for implantable devices. Trials should be documented in the medical record and prior non‑implant trials should be reported in the prior authorization request.

Documented trial of a headband/softband BCHA is expected before considering implantation in children when feasible.
Non-implant trial results (aided benefit in speech recognition, subjective improvement, or quality-of-life measures) should be included in the PA submission.

Prior Authorization

Confirm Device‑Specific Indications on PA

Prior authorization review must verify that the patient meets the specific selection criteria for the requested device (for example, Vibrant Soundbridge, BAHA, Bonebridge, Osia systems, Otomag/Sophono indications). Confirm age restrictions, PTA thresholds, word recognition requirements, and any prerequisite experience with appropriately fitted air conduction or bone conduction hearing aids.

Vibrant Soundbridge: adults ≥18 years, device-specific PTA AC ranges and WRS ≥50%.
BAHA indications and age criteria (including SSD and bilateral implantation criteria) per FDA labeling.
Bonebridge/Osia: age and PTA BC/AC thresholds and recommendation for prior use of appropriately fit hearing aids.
Otomag/Sophono: PTA BC thresholds and bilateral symmetry criteria; age indications as specified.

Documentation Required

Device‑Specific Audiometric Evidence Required

Device-specific audiometric criteria must be included with the PA: report PTA (BC and/or AC) at 0.5, 1, 2 and 3 (and 4) kHz as applicable, word recognition score using recorded material, and comparison of aided vs unaided performance when available. For SSD indications, include contralateral ear PTA AC to demonstrate normal hearing where required.

Include PTA values (0.5,1,2,3 kHz; include 4 kHz when specified) and specify BC or AC as required by the device.
Provide word recognition scores (WRS) measured with recorded material when device labeling requires a minimum WRS.
For SSD requests, document contralateral ear AC PTA (e.g., ≤20 dB HL at 0.5,1,2,3 kHz) if required by the device indication.

Billing Rule

Use Updated Codes for Authorization

Use the policy’s current, updated CPT/HCPCS codes when submitting authorization requests. The code list in this policy was updated effective 08/01/2025 and includes newly added procedure codes for totally implantable active middle ear implants.

Ensure authorization and billing use the updated codes (including 0951T–0955T and the listed 69xxx series codes).
Listing of a code in the policy does not guarantee coverage; verify benefit plan terms.

Note

Evidence Quality May Affect Coverage Decisions

Evidence quality for many implantable and partially implantable devices is limited (low to very-low-quality, lacking randomized controlled trials). This uncertainty may affect coverage determinations and the requirement for individual justification and documentation of benefit.

Reviewers may require additional justification when evidence is limited or device comparisons are inconclusive.
Clinical benefit demonstrated in lower-quality studies does not guarantee coverage without meeting policy and benefit criteria.

Prior Authorization

Device Selection Must Match FDA‑Labeled Criteria

Device selection and patient candidacy must align with applicable FDA-labeled criteria and professional labeling. Prior authorization should reference the relevant FDA professional labeling or PMA/510(k)/de novo documentation to demonstrate that the member meets the device-specific criteria.

Reference the FDA professional labeling (PMA/510(k)/de novo) for device selection criteria and include citations or links in the PA when available.
Selection criteria include age limits, audiometric thresholds, WRS, middle ear anatomy, and prior hearing aid experience if required.

Note

Reference Governing Benefit Documents

When applying this policy, always reference the member’s governing benefit documents (federal, state, or contractual). If a conflict exists between this standard policy and governing benefit documents, the federal/state/contractual requirements govern.

Check state-specific policy versions where applicable; this policy may not apply in certain states.
In the event of conflict, the governing benefit plan terms control coverage decisions.

Billing Rule

Equipment Upgrades and Replacements Treated as New Services

Equipment upgrades, revisions, or changes in the member’s medical condition are treated as new services for authorization and must meet the same criteria as initial implantation or device provision.

Requests for equipment upgrades or replacement devices require a full PA with current clinical documentation demonstrating continued medical necessity.
Replacement only procedures (e.g., sound processor replacement) must meet device-specific and policy criteria.

UseDegree categories per ASHA/Clark used for audiologic classification in policy

Hearing Aids (policy definition)

Policy definitionSound‑amplifying devices designed to aid people with hearing impairment; includes semi‑implantable electromagnetic and bone‑anchored devices

ClassificationMany non‑wearable devices that bring sound into the ear are treated as Hearing Aids for this policy

TechnologyMay be analog or digital and share similar electronic components

Non-implantable BCHA — Definition

DefinitionNon‑implantable bone conduction hearing aid (BCHA) retained by headband or adhesive transmitting vibrations transcutaneously to skull

Use caseUsed when air‑conduction aids are not possible (e.g., congenital external ear malformations)

Trial roleOften used as a trial in children/adults prior to implantation; children may use until temporal bone matures

Semi-implantable electromagnetic hearing aid (SEHA)

MechanismImplanted magnetic device in the middle ear is driven by an external processor; implant vibrations directly drive ossicles

ClassificationClassified by FDA as Hearing Aids (semi‑implantable electromagnetic devices)

ExamplesVibrant Soundbridge, Maxum (formerly Soundtec), MET Ossicular Stimulator

Bone-anchored hearing aid (BCHA/BAHA)

DefinitionSurgically implanted system conducting sound via osseointegrated titanium screw (percutaneous) or subdermal magnetic implant (transcutaneous)

VariantsPercutaneous (abutment) and transcutaneous (magnetic coupling) systems exist

IndicationsIndicated for conductive/mixed hearing loss or single‑sided deafness per FDA labeling

Laser/light-based hearing aid

DefinitionTransmits sound as light pulses from a BTE processor to a tympanic membrane transducer placed in ear canal

ComponentsLight‑based behind‑the‑ear sound processor and removable tympanic membrane transducer

CapabilityProvides extended high‑frequency amplification (up to 10 kHz) and demonstrated mean functional gain (~31 dB across 2–10 kHz)

Totally implanted middle ear system

DefinitionDevice completely implanted in middle ear and mastoid with implanted sensor, driver and internal power source (no external microphone/speaker)

ComponentsImplanted sound processor, sensor, and driver; internal maintenance‑free battery reported in some systems

Evidence statusEvidence quality limited; clinical findings and adverse events reported — considered investigational/unproven in policy

BAHA / Bone-anchored hearing aid — Historical and current context

Historical contextOriginally marketed as the Branemark BAHA (1995 FDA clearance) and subsequently evolved into multiple commercial systems (Cochlear Baha, Ponto, etc.)

Current contextIncludes percutaneous and transcutaneous magnetic coupling systems (e.g., BAHA Attract, Bonebridge, Osia)

Indications and evolutionIndications broadened over time to include bilateral implantation and SSD; device models vary in PTA thresholds and age minima

Earlens (light-driven contact hearing aid)

DescriptionContact hearing aid that directly drives the tympanic membrane via a custom transducer placed in the ear canal

High‑frequency capabilityAllows extended amplification up to 10 kHz with reported mean functional gain of ~31 dB across 2–10 kHz

Regulatory statusCleared by FDA following investigational trial data (de novo/510(k) pathway)

Normal hearing (for SSD indications)

Definition used for SSD indicationsNormal hearing defined as PTA air‑conduction threshold equal to or better than 20 dB measured at 0.5, 1, 2 and 3 kHz

ApplicationRequired contralateral hearing standard when considering BAHA/Bonebridge/Osia for SSD

Measurement frequencies0.5, 1, 2, and 3 kHz

Symmetrical bone-conduction thresholds

Symmetry definition (average)Less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz)

Per‑frequency allowanceLess than a 15 dB difference at individual frequencies

UseApplies to bilateral fitting and bilateral implantation candidacy

References (device efficacy and safety literature)

Systematic reviewsMultiple systematic reviews cited on BAHA efficacy in SSD and implantable device safety (e.g., Kim et al. 2017; Klein et al. 2012)

Device studiesClinical studies and cohort reports including trials of Earlens, Bonebridge, Osia, and totally implanted systems (Gantz 2017; Shohet 2018)

Policy roleReferences support device indications, limitations, and evidence quality assessments used in the policy

Updated applicable CPT codes to reflect quarterly edits and added CPT codes 0951T, 0952T, 0953T, 0954T, and 0955T.