ModifiedUnitedHealthcarePolicy CS052IN.09

Hearing Aids and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Indiana Only)

Policy governs coverage and clinical criteria for wearable, bone-anchored, and semi-implantable hearing aids and related devices for UnitedHealthcare members in Indiana. It directs providers to state-specific modules and InterQual criteria for medical necessity, repair, and replacement.

Policy Summary

PayerUnitedHealthcare

PolicyHearing Aids and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Indiana Only)

Policy CodePolicy CS052IN.09

Change TypeCode list updated — CPT codes 0951T–0955T added

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionVerify plan prior authorization requirements and document device-specific indications and audiometric data when submitting authorization requests.

SourceLink

POLICY UPDATE CHANGES

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

Archived previous policy version CS052IN.08.

0951T–0955Tnewly listed applicable CPT codes

Indiana-onlygeographic applicability

3 listedunproven device types

limitedevidence quality

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InterQual referencedmedical necessity source

Coverage and Medical Necessity Criteria

General coverage routing and unproven device list

Coverage and medical necessity determinations rely on referenced clinical criteria sources; the following device types are explicitly listed as unproven.

State-specific wearable air conduction devices: Refer to the Indiana Health Coverage Programs Provider Reference Module: Hearing Services for clinical coverage, repair, and replacement criteria.

state-specific guidance overrides or complements this policy

Non state-specific devices: Use InterQual CP: Durable Medical Equipment, Hearing Aids for medical necessity clinical criteria for wearable and non-implant hearing devices.

InterQual links provided

Bone-anchored and bone conduction devices: Use InterQual CP: Procedures: Hearing Device, Bone Anchored or Bone Conduction (adult and pediatric) for medical necessity criteria.

InterQual referenced

Semi-implantable and middle ear devices: Use InterQual CP: Procedures, Hearing Device, Middle Ear for medical necessity criteria of semi-implantable devices.

InterQual referenced

Non-covered / unproven devices: The following are unproven and not medically necessary for treating hearing loss due to insufficient evidence: intraoral bone conduction hearing aids (eg, SoundBite), laser or light-based contact hearing aids (eg, Earlens CHD), and totally implantable middle ear hearing systems (eg, Carina, Esteem).

explicitly listed as unproven

Intraoral Bone Conduction Hearing Aid – evidence and limitations

Intraoral bone conduction hearing aid (SoundBite):

Evidence summary: Available studies are of insufficient quality (small cohorts, short follow-up, lack of randomization and control groups) to support routine use.

Insufficient quality evidence

Study findings: Prospective case series (Gurgel et al. 2015) reported improved APHAB scores and high patient satisfaction at 6–12 months but had no control group and noted withdrawals for device problems; a small 9‑patient crossover (Moore & Popelka 2013) found similar localization and speech perception versus BAHI but was limited by sample size and short duration.

Patient‑reported benefit reported but methodological limitations limit strength of evidence

Availability note: The SoundBite system has been discontinued by its manufacturer, which may preclude coverage for that specific device.

Device ceased manufacture

Light-driven / Laser-based Contact Hearing Devices

Laser or light-based contact hearing devices (Earlens CHA):

Device description: Light-driven contact hearing devices (eg, Earlens CHD) use a behind‑the‑ear processor that transmits light to a tympanic membrane transducer placed deep in the ear canal; Earlens was cleared via the FDA de novo pathway.

Device mechanism and regulatory pathway

Evidence summary: Clinical trials and single‑arm studies demonstrate improved functional gain (up to 10 kHz) and improved patient‑reported communication versus unaided listening, with small improvements versus patients' own hearing aids in some measures, but studies were unblinded and lacked randomized concurrent comparisons.

Evidence limitations may affect strength of conclusions

Safety findings: A pivotal single‑arm trial reported no serious device‑ or procedure‑related adverse events and no clinically meaningful change in residual hearing at 120 days; mean functional gain and word recognition improvements were observed.

Supports FDA clearance but further comparative data recommended

Totally Implantable Middle Ear Hearing Systems

Totally implantable middle ear hearing systems (Carina, Esteem):

Evidence summary: Studies (case series, observational cohorts, systematic reviews) report improvements in functional gain, speech perception, and quality‑of‑life metrics in some patients but are heterogeneous and limited by lack of randomized controlled trials and small sample sizes.

Insufficient high‑quality evidence for routine coverage

Harms and device issues: Reported adverse events include device failure, explant or revision surgery, chorda tympani nerve injury or taste disturbance, facial weakness, and battery/charging issues; complication rates vary between devices in reported series.

Safety concerns contributed to limited evidence strength

Professional guidance: AAO‑HNS considers active middle ear implants appropriate for selected adults with moderate‑to‑severe hearing loss who cannot benefit from conventional hearing aids when performed by qualified surgeons, but recommends adherence to FDA‑specified restrictions.

Society position supports selective use within labeled indications

Semi-implantable electromagnetic devices and Bone-Anchored Hearing Aids

Semi-implantable electromagnetic and bone-anchored hearing devices:

Regulatory and indications: Several semi‑implantable electromagnetic devices (eg, Vibrant Soundbridge, Maxum) and bone‑anchored systems (BAHA, Bonebridge, Osia) have FDA approval or clearance with device‑specific selection criteria including age, audiometric ranges, word recognition minimums, and prior hearing aid experience.

Refer to FDA professional labeling for numeric thresholds

BAHA SSD indication: BAHA is indicated for single‑sided deafness to improve speech recognition when the contralateral ear has normal hearing (PTA AC ≤20 dB at 0.5, 1, 2, and 3 kHz) or when an AC CROS is not acceptable or used.

SSD and bilateral indication details in device labeling

Device candidacy examples: Examples of device‑specific candidacy include: Vibrant Soundbridge adults ≥18 with specified pure tone AC ranges (eg, 500 Hz 30–65 dB, 1000 Hz 40–75 dB, etc.); Bonebridge for patients ≥12 with BC PTA ≤45 dB HL; Osia systems for patients ≥12 with BC PTA thresholds up to device‑specified limits.see device labeling

FDA-labeled device eligibility

Coverage is aligned with FDA indications and device‑specific labeling; devices are considered when ALL applicable device‑labeled conditions are met:

Device-specific eligibility: Patient meets device‑specific age and audiometric criteria per FDA labeling (examples: BAHA: adults and children ≥5 with PTA BC thresholds and indication criteria; Bonebridge: patients ≥12 with BC PTA ≤45 dB HL; Osia: patients ≥12 with BC PTA thresholds per labeling).see device labels

Refer to device sections and FDA professional labeling for exact frequencies, PTA calculations, and word recognition thresholds

Prior trial with non-implantable amplification

Prior hearing aid experience: Prior experience with appropriately fitted air conduction or bone conduction hearing aids is recommended before implantation for systems such as Bonebridge and Osia; AAO‑HNS guidance likewise implies conventional amplification should be considered prior to middle ear implants when appropriate.recommended

Recommended step per device labeling and professional guidance; documentation should be provided when requesting authorization

This policy identifies several device types as unproven and not medically necessary due to insufficient evidence of efficacy: intraoral bone conduction hearing aids (e.g., SoundBite), laser or light-based contact hearing devices (e.g., Earlens CHD), and totally implantable middle ear hearing systems. The determination reflects the limited quality and quantity of published studies, including small sample sizes, short follow-up, and lack of randomized controlled trials, which limit confidence in sustained benefit for routine treatment of hearing loss.

Devices or approaches lacking sufficient high-quality evidence are described as not supported for routine coverage. Examples noted in the policy include intraoral bone conduction devices, where studies were small and nonrandomized; laser/light-based contact hearing devices, for which published trials were single-arm or non-blinded; and totally implantable middle ear systems, where available observational series and systematic reviews show heterogeneous outcomes and methodological limitations. In the absence of compelling, high-quality evidence demonstrating clinically meaningful benefit, these device types are not considered medically necessary.

Some devices referenced in the literature have ceased manufacture; for example, the SoundBite intraoral bone conduction system is no longer produced (manufacturer ceased manufacturing after bankruptcy). Lack of ongoing production or commercial availability for a specific named device may preclude coverage for that exact device and is noted in the policy as a discontinued product reference.

This Medical Policy is provided for informational purposes to assist interpretation of UnitedHealthcare standard benefit plans. Coverage decisions must be made in accordance with the applicable federal, state, or contractual benefit requirements that govern the member's plan; in the event of a conflict, those governing benefit terms prevail.

For clarity, the policy explicitly lists these categories as unproven: Intraoral bone conduction hearing aids (non-surgical oral retainer systems), Laser or light-based contact hearing devices (light-transmission CHDs with tympanic membrane transducers), and Totally implantable middle ear hearing systems (fully implanted active middle ear devices such as Carina and Esteem).

Evidence limitations are emphasized: studies of intraoral bone conduction devices and totally implantable systems are generally low quality — often small cohorts, short follow-up, and lacking randomized or controlled comparisons. Systematic reviews and individual series report heterogeneous results and methodological weaknesses, constraining confidence in effectiveness and durability of benefit.

The policy cautions against use of devices outside the numeric or age ranges described in FDA labeling. Implantation or use of a device for patients who do not meet the FDA-specified audiometric thresholds, age limits, or indication definitions (for example, PTA BC limits, minimum age recommendations, or single-sided deafness criteria) may be inconsistent with labeled indications and could be considered not medically necessary.

Applicable CPT / HCPCS Codes and Audiometric Ranges

Applicable CPT/HCPCS codes for fittings, implants, BAHA, and wearable hearing aidsmixed

92590	Hearing aid examination and selection; monaural.
92591	Hearing aid examination and selection; binaural.
92592	Hearing aid check; monaural.
92593	Hearing aid check; binaural.
92594	Electroacoustic evaluation for hearing aid; monaural.
92595	Electroacoustic evaluation for hearing aid; binaural.
69799	Unlisted procedure, middle ear.
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.

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Applicable CPT/HCPCS codes (updated)CPT

0951T	Listed as newly added CPT/HCPCS in policy update
0952T	Listed as newly added CPT/HCPCS in policy update
0953T	Listed as newly added CPT/HCPCS in policy update
0954T	Listed as newly added CPT/HCPCS in policy update
0955T	Listed as newly added CPT/HCPCS in policy update

Applicable CPT/HCPCS Codes (added)CPT

0951T	procedure code added per quarterly edits
0952T	procedure code added per quarterly edits
0953T	procedure code added per quarterly edits
0954T	procedure code added per quarterly edits
0955T	procedure code added per quarterly edits

Degree of Hearing Loss — dBHL ranges for severity categories

Normal hearing-10 to 15 dB HL

Slight hearing loss16 to 25 dB HL

Mild hearing loss26 to 40 dB HL

Moderate hearing loss41 to 55 dB HL

Moderately severe hearing loss56 to 70 dB HL

Severe hearing loss71 to 90 dB HL

Profound hearing loss

Prior Authorization, Documentation, and Billing Guidance

Note

Prior Authorization and Documentation Overview

The following provider actions and reminders apply when requesting authorization, documenting medical necessity, and submitting claims for implantable and non‑implantable hearing devices.

Denial Risk

Coverage not implied by code listing

Listing of a code in this policy does not imply the service is covered. Benefit coverage is determined by applicable federal, state, or contractual requirements and laws; inclusion of a code is for reference only and is not a guarantee of reimbursement or payment.

Benefit terms govern coverage — verify plan-specific covered benefits before submission.
Do not assume coverage solely because a CPT/HCPCS code appears in this policy.

Note

Clinical and Evidence Background

Background: Hearing loss encompasses conductive, sensorineural, and mixed types. Conductive hearing loss involves impaired transmission through the outer or middle ear and may be correctable; sensorineural hearing loss involves cochlear or neural damage and is usually permanent. Degrees of hearing loss are defined by decibel hearing level ranges (e.g., Normal -10 to 15 dBHL, Mild 26–40 dBHL, Moderate 41–55 dBHL, Severe 71–90 dBHL), which inform device candidacy and device-specific audiometric thresholds referenced elsewhere in the policy.

Key Terms and Device Definitions

Conductive Hearing Loss — definition and clinical features

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

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

ReversibilityOften can be corrected medically or surgically

Sensorineural Hearing Loss (SNHL) — definition and clinical implications

DefinitionDamage to the inner ear (cochlea) or to the auditory nerve pathways

Clinical implicationUsually cannot be medically or surgically corrected and is the most common permanent hearing loss

Policy Updates and Effective Dates

2025-08-01codes_added/policy_revisionLatest

Updated list of applicable CPT codes to reflect quarterly edits; added CPT codes 0951T, 0952T, 0953T, 0954T, and 0955T, and archived previous policy version CS052IN.08.

Policy Summary

PayerUnitedHealthcare

PolicyHearing Aids and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Indiana Only)

Policy CodePolicy CS052IN.09

Change TypeCode list updated — CPT codes 0951T–0955T added

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionVerify plan prior authorization requirements and document device-specific indications and audiometric data when submitting authorization requests.

SourceLink

On This Page

Exact frequency and threshold criteria vary by device and are documented in FDA labeling

Pure tone air conduction threshold selection ranges (Vibrant Soundbridge)

500 Hz30–65 dB HL

1000 Hz40–75 dB HL

1500 Hz45–80 dB HL

2000 Hz45–80 dB HL

3000 Hz50–85 dB HL

4000 Hz50–85 dB HL

BAHA candidacy — candidacy criteria and age considerations

Adult candidacyAdults with external ear malformations, chronically draining ear, or inability/unwillingness to use air-conduction hearing aid; PTA AC threshold ≥45 dB HL

Pediatric candidacyChildren aged 5 years and older (BAHA clearance extended to ≥5 years)

Bilateral implantationAllowed for bilateral symmetrical conductive or mixed hearing loss when average BC thresholds are better than 45 dB and symmetry criteria met

Pure Tone Average (PTA) thresholds — device-specific examples and ranges

Common device BC PTA thresholdBone-conduction PTA ≤45 dB HL is a commonly cited eligibility threshold

BP110 / Power processorsUp to 55 dB HL for BP110/Power processors (device-specific)

Cordelle II / SuperPowerUp to 65 dB HL for Cordelle II and SuperPower processors

SSD normal ear AC PTANormal ear for SSD defined as AC PTA ≤20 dB HL at 0.5, 1, 2, and 3 kHz (relevant to device labeling)

Regulatory status informational

FDA approval or clearance is provided here for informational context only. FDA regulatory status alone is not sufficient to establish coverage; providers must meet the plan's medical necessity and benefit criteria.

When devices are used outside the FDA‑labeled indications (nonconcordant use), coverage may be inconsistent with policy.

Denial Risk

Indication nonconcordance

Devices used outside of the labeling characteristics (age ranges, audiometric thresholds, word recognition scores, anatomy, prior hearing aid trials) may be considered nonconcordant with indicated use and thus inconsistent with coverage.

Document how the device selection aligns with labeling characteristics (age, audiometric thresholds, word recognition scores, anatomy).
If device use is outside labeled indications, include clinical rationale and supporting documentation for medical necessity.

Note

Coverage determinations must reference federal/state/contractual requirements

Coverage determinations must follow federal, state, and contractual benefit requirements. If there is conflict between this policy and plan‑specific or regulatory requirements, the federal/state/contractual requirements govern.

Check and document the applicable benefit plan (federal/state/contract) before submission.
For Indiana members, follow the Indiana Provider Reference Module where state‑specific repair/replacement or service rules apply.

Prior Authorization

Use InterQual for medical necessity

Use the InterQual clinical criteria referenced by UnitedHealthcare when assessing medical necessity for specific device types. Authorization decisions will consider InterQual determinations where applicable.

InterQual topics referenced: Durable Medical Equipment — Hearing Aids; Procedures — Hearing Device, Bone Anchored or Bone Conduction (adult and pediatric); Procedures — Hearing Device, Middle Ear.
Link to InterQual criteria is available on the UHC provider site; include the InterQual justification in the clinical documentation submitted for prior authorization.

Documentation Required

Device labeling and selection criteria — document for authorization

Document device labeling and selection criteria when requesting authorization: age, audiologic thresholds (PTA AC/BC at specified frequencies), word recognition scores, middle ear anatomy, and prior therapy or hearing aid trials.

Include pure tone averages and bone conduction thresholds measured at 0.5, 1, 2 and 3 kHz (and individual frequency thresholds when relevant).
Provide word recognition scores (recorded material) and specify laterality (unilateral vs bilateral).
State the device model and reference the manufacturer labeling used to support candidacy.

Documentation Required

Conventional hearing aids trial implied

Prior to implanting active middle ear implants or bone conduction devices, document that conventional, appropriately fitted air‑conduction or bone‑conduction hearing aids were tried and found insufficient when such trials are part of the device labeling or professional guidance.

Record dates, device type, fitting provider, and objective outcomes from the trial(s).
When labeling recommends prior experience with appropriately fit hearing aids, include audiologic reports showing benefit (or lack thereof).

Prior Authorization

Recommendation for prior non‑implant trials

Recommendation: document prior non‑implant trials as indicated by device labeling and FDA guidance (e.g., appropriately fitted air or bone conduction aids) before requesting implantation when labeling or InterQual criteria require prior trials.

If a prior trial was not possible or clinically contraindicated, include detailed rationale and supporting clinical notes.
Authorization requests lacking evidence of prior trials when required may be denied or returned for additional information.

Relation to degreeDegree of SNHL is described using dB HL categories from slight to profound (see degree thresholds)

Degree of Hearing Loss — dBHL ranges for severity categories (repeat for definitions section)

Normal-10 to 15 dB HL

Slight16 to 25 dB HL

Mild26 to 40 dB HL

Moderate41 to 55 dB HL

Moderately severe56 to 70 dB HL

Severe71 to 90 dB HL

Profound91 dB HL or more

Light-driven contact hearing device (CHD) — description (Earlens)

Device typeLight-driven contact hearing device (e.g., Earlens CHD) uses a behind-the-ear light-based processor and a tympanic membrane transducer

MechanismBTE processor converts sound to infrared light pulses transmitted to a deep canal transducer that converts light to vibrations applied to the tympanic membrane

Regulatory noteEarlens CHD was cleared by FDA via the de novo pathway

Intraoral bone conduction hearing aid (IOBC / SoundBite) — definition and mechanism

DefinitionNon-surgical intraoral bone conduction system consisting of a behind-the-ear component and a removable custom oral retainer that transmits sound via the teeth and skull bones to the cochleae

Indication originDeveloped for individuals with single-sided deafness (SSD)

Availability noteManufacturer (Sonitus) ceased manufacturing the SoundBite system as of January 1, 2015

Totally implantable middle ear hearing system — definition and components (Carina, Esteem)

DefinitionAn implanted system with a sound processor, sensor, and driver placed in the middle/behind the ear to convert signals to the inner ear without external microphone or speaker

Components examplesExamples include the Esteem (Envoy) and Carina (Cochlear) totally implantable active middle ear devices

Clinical considerationsReported device-specific complications include device failure, need for explant/revision, and implant-related nerve effects; evidence is limited and heterogeneous

Bone-anchored hearing aid (BAHA / BCHD) — definition and indications

DefinitionA percutaneous or transcutaneous implanted bone conduction device that transmits sound via bone conduction for conductive/mixed hearing loss or single-sided deafness

Common indicationsIndicated for patients with external ear malformations, chronically draining ear, inability/unwillingness to use air-conduction hearing aid, or SSD per FDA labeling

Age and PTA examplesCleared for children ≥5 years (BAHA); BC PTA eligibility commonly cited as ≤45 dB HL for many processors

Single-Sided Deafness (SSD) — definition and audiometric criteria

DefinitionUnilateral sensorineural deafness in one ear with normal hearing in the contralateral ear

Audiometric criterion for normal earContralateral normal hearing defined as AC PTA ≤20 dB HL at 0.5, 1, 2, and 3 kHz

RelevanceSSD is an FDA-labeled indication for certain BAHA and non-implantable bone-conduction systems

Symmetrical bone-conduction thresholds — definition of symmetry thresholds

Symmetry definitionSymmetrical bone-conduction thresholds: less than 10 dB average difference between ears (0.5, 1, 2, 3 kHz) or less than 15 dB difference at individual frequencies

Use caseRequired for bilateral fitting/implantation eligibility for certain bone-anchored devices

Measurement frequenciesTypically measured at 0.5, 1, 2, and 3 (or 4) kHz depending on device labeling

Implantable hearing devices — definition and examples of totally/partially implantable systems

DefinitionSurgically implanted hearing systems that are totally or partially implanted to provide mechanical or electrical stimulation to the middle/inner ear

Examples of totally implantable systemsCarina (Cochlear) and Esteem (Envoy) — fully implanted active middle ear devices

Examples of partially implantable systemsVibrant Soundbridge, Bonebridge, Osia — semi-implantable electromagnetic or bone-conduction systems with implanted and external components