RetiredUnitedHealthcarePolicy CS052LA.O

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

Policy governing coverage and medical necessity criteria for wearable, bone-anchored, and semi-implantable hearing aids and related devices for Louisiana Medicaid beneficiaries; applies to providers and members in Louisiana.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS052LA.O

Change TypeRetirementcoding update

Effective DateAugust 1, 2025 - March 31, 2026

Next Review DateN/A

Key ActionDocument audiometric evidence of significant hearing loss (>20 dB PTA 250–2000 Hz) from an otologist and a hearing aid provider when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

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

Retired Apr 1, 2026policy retirement date

Louisiana onlystate applicability

<21EPSDT age cutoff

>20 dBsignificant hearing loss threshold

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 and Medical Necessity Criteria

Covered Devices / Eligibility

Covered when ALL of the following are met (state-specific items separate):

State-specific eligibility: Member is EPSDT-eligible (under 21) and has significant hearing loss (>20 dB average 250-2000 Hz)age <21; >20 dB

Requires audiometric data from both an otologist and a hearing aid provider

Non-state-specific covered devices: Wearable air-conduction hearing aids; bilateral fully or partially implantable bone-anchored hearing aids for conductive or mixed hearing loss; bilateral or unilateral bone conduction hearing aids utilizing a headband or adhesive (non-implantable); semi-implantable electromagnetic hearing aids for sensorineural hearing loss; unilateral fully or partially implantable bone-anchored hearing aids for conductive, mixed, or select sensorineural lossUse according to FDA-labeled indications

Devices must be used consistent with FDA labeled indications, contraindications, warnings, and precautions

Unproven / Not Medically Necessary

Not covered (unproven) due to insufficient evidence:

Unproven devices: Intraoral bone conduction hearing aids (eg, SoundBite); laser or light-based hearing aids; totally implanted middle ear hearing systemsinsufficient evidence of efficacy

SoundBite is no longer manufactured; these technologies lack high-quality comparative evidence

General coverage criteria for bone conduction and alternative hearing devices

Covered when ALL of the following are met (based on evidence summaries and typical clinical practice implied in the document):

Appropriate indication: Device type and indication are appropriate (conductive or mixed hearing loss, single-sided deafness, or selected sensorineural loss per device labeling).FDA-labeled indications apply

See device-specific evidence and FDA labeling for precise audiometric thresholds

Documented non-surgical trial when practicable: A demonstrated audiologic or quality-of-life benefit from a non-implantable trial (softband/headband/adhesive) is documented, especially in pediatric patients prior to implantation.trial documented in chart

Systematic reviews and cohort studies support trialing headband/softband prior to implantation in children

Device selection and patient factors:

Intraoral bone conduction hearing aids

Not covered / investigational when ANY of the following apply:

Intraoral devices (IOBC): Device is an intraoral bone conduction hearing aid (eg, SoundBite) for which there is insufficient quality evidence to support routine coverage; device manufacturing ceased and it is no longer available for supply.insufficient evidence

Studies are small, nonrandomized, short follow-up; manufacturer bankruptcy noted

Device-specific coverage considerations

Coverage considerations and clinical conclusions summarized from the evidence and guidance in this document excerpt.

Intraoral bone conduction (IOBC): Evidence is limited by low-quality studies (small samples, short follow-up, lack of controls); while single-arm series report patient satisfaction and APHAB improvements, limitations constrain generalizability.

Gurgel et al. 2015: 81 patients; selection and attrition biases noted

Light-driven contact hearing aid (Earlens): Single-arm and investigational trials show improved aided word recognition and self-reported benefit versus unaided or prior hearing aids; FDA clearance exists but direct comparative effectiveness remains uncertain.

Arbogast 2019 and Gantz 2017 report functional gains and improved word recognition but studies lacked blinded concurrent controls

Totally implanted middle ear systems (Carina, Esteem): Studies show functional gain and improved speech outcomes compared with unaided or baseline aided conditions, but evidence is limited by single-arm designs, heterogeneous results, and reported adverse events and device failures.

Systematic reviews and case series report variable benefit and notable complications

FDA-indication-based coverage

Device indications as described by FDA clearances/approvals (device-specific coverage depends on matching indications and audiometric criteria):

Indications summary: Coverage applies when the member meets device-specific FDA indications: conductive or mixed hearing loss with PTA bone-conduction thresholds within device-specific limits, single-sided deafness with normal contralateral hearing (AC PTA <=20 dB HL), age requirements per device, and bilateral symmetry criteria when bilateral fitting is requested.device-specific PTA and age limits apply

See individual device sections for exact numeric thresholds and age minima

Osia System / Osia 2 System

Osia Systems specific requirements

Osia/Osia2 eligibility: Patient meets Osia System or Osia 2 System FDA-labeled indications: age >=12 years; PTA bone-conduction (BC) threshold <=55 dB HL; bilateral fittings require BC symmetry (average difference <10 dB or <15 dB at individual frequencies); SSD candidates must have contralateral AC PTA <=20 dB HL; recommended prior experience with appropriately fitted air or bone conduction hearing aids.age >=12; BC PTA <=55 dB HL; contralateral AC PTA <=20 dB HL

Per FDA 510(k) summaries (K190589, K191921)

Baha Attract and Bonebridge

Baha and Bonebridge device requirements

Baha Attract: Patients aged >=5; conductive or mixed hearing loss with PTA BC <=45 dB HL for BP100 processor or <=55 dB HL for BP110 Power processor; bilateral fitting requires symmetry criteria; SSD permitted with contralateral AC PTA <=20 dB HL.age >=5; BC PTA <=45-55 dB HL depending on processor

Per Cochlear Baha Attract FDA clearance

Bonebridge: Patients aged >=12; conductive or mixed hearing loss with PTA BC <=45 dB HL; bilateral symmetry criteria apply; SSD candidates require contralateral AC PTA <=20 dB HL; prior experience with appropriately fitted air or bone conduction hearing aids is recommended.age >=12; BC PTA <=45 dB HL

Per Bonebridge de novo and 510(k) clearances

Non-implantable bone-conduction devices

Non-implantable (headband/softband/adhesive) devices

BAHA headband / Softband / SoundArc / ADHEAR / BP100/BP110: Intended for conductive or mixed loss meeting device-specific BC PTA thresholds (examples: BP100 <=45 dB HL; BP110 Power <=55 dB HL; SoundArc and Cordelle II up to 65 dB HL for SuperPower processors; ADHEAR <=25 dB HL); SSD indicated if contralateral AC PTA <=20 dB HL; age indications vary (Softband/headband used for children, some processors cleared for ages >=5 or for all ages).device-specific BC PTA thresholds and age limits

FDA 510(k) summaries describe processor-specific thresholds and age recommendations

Middle ear and contact hearing devices

Other implantable/contact middle ear devices

Totally implanted and contact devices: Devices such as the Esteem totally implanted middle ear system and the Earlens contact hearing device have FDA approvals/clearances with specific age and hearing loss ranges (eg, Earlens indicated for adults >=18 with mild to severe SNHL). Coverage requires that the patient match device-specific labeling and clinical criteria.device-specific

Refer to PMA/510(k) documents for each device

The policy identifies several device categories as unproven / not medically necessary for treating hearing loss due to insufficient evidence of efficacy: intraoral bone conduction hearing aids, laser or light-based hearing aids, and totally implanted middle ear hearing systems. When these technologies are proposed, documentation should note that they are not supported by high-quality evidence in this policy and are therefore excluded from routine coverage.

Use of intraoral bone conduction hearing aids (eg, the SoundBite system) is specifically unsupported by high-quality evidence and routine coverage cannot be recommended. In addition, production of the SoundBite device ceased after the manufacturer filed bankruptcy on January 1, 2015, and the device is no longer manufactured or commercially available.

Procedures or device uses that are supported only by low-quality, uncontrolled evidence (for example, single-arm case series, small cohorts, or studies with short follow-up) are presented in the literature for context but are not sufficient basis for routine coverage. Examples include some intraoral bone conduction approaches and totally implanted middle ear systems, where the available studies lack randomized or appropriately controlled designs and have inconsistent outcomes or identified adverse events.

The SoundBite Hearing System (an intraoral bone conduction device) is no longer in production. Sonitus Medical, Inc. filed bankruptcy effective January 1, 2015, and manufacturing of the SoundBite device ceased; there is no new information suggesting resumption of production.

The policy explicitly lists the following devices as considered unproven / not medically necessary: intraoral bone conduction hearing aids, laser or light-based hearing aids, and totally implanted middle ear hearing systems.

Routine coverage for intraoral bone conduction hearing aids is not supported because the evidence base is low quality, consisting of small, nonrandomized studies with short follow-up, and because at least one representative device (SoundBite) is no longer manufactured.

Available studies of intraoral bone conduction hearing aids are of insufficient methodological quality to demonstrate efficacy for treating hearing loss. The evidence is limited by small sample sizes, short follow-up periods, and lack of randomization or adequate control groups.

Informational: this policy was retired for the Louisiana plan, and Louisiana plan membership was disenrolled on April 1, 2026. This retirement may affect coverage determinations for members of that plan after that date.

Procedure and Billing Codes

Bone Anchored Hearing Aids (BAHA)CPT

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.

Fitting/Testing and Totally Implantable Middle Ear ImplantCPT

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.
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.

1–10 of 12

1/2

Fitting/HCPCS/L-codes and Wearable Devicesmixed

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.
L8690	Auditory osseointegrated device, includes all internal and external components.
L8691	Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each.
L8694	Auditory osseointegrated device, transducer/actuator, replacement only, each.
L8692	Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment.

1–10 of 14

1/2

Wearable Hearing Aid HCPCS V-codesHCPCS

V5070	Glasses, air conduction.
V5080	Glasses, bone conduction.
V5100	Hearing aid, bilateral, body worn.
V5120	Binaural, body.
V5130	Binaural, in the ear.
V5140	Binaural, behind the ear.
V5150	Binaural, glasses.
V5171	Hearing aid, contralateral routing device, monaural, in the ear (ITE).
V5172	Hearing aid, contralateral routing device, monaural, in the canal (ITC).

Regulatory/Informational (no billing codes listed in this excerpt)mixed

No codes listed

Applicable CPT codes (updated)CPT

0951T	listed in updated applicable CPT codes (document note)
0952T	listed in updated applicable CPT codes (document note)
0953T	listed in updated applicable CPT codes (document note)
0954T	listed in updated applicable CPT codes (document note)
0955T	listed in updated applicable CPT codes (document note)

inv-25: Significant hearing loss — defined as >20 decibels average hearing level in the range 250-2000 Hz.

Definition>20 decibels (dB) average hearing level in the range 250–2000 Hz

Measurement requirementAverage calculated from audiometric data across 250, 500, 1000, 2000 Hz (policy uses 250–2000 Hz range)

DocumentationAudiometric data must be provided by both an otologist (ear specialist) and a hearing aid provider

inv-26: Audiometric thresholds and age for device indications — examples of device-specific thresholds and age indications.

Example: BAHA/Bonebridge (BP100/Bonebridge)

Documentation, Prior Authorization, and Clinical Actions

Prior Authorization

Prior authorization required — submit code-based documentation

Prior authorization is required and must be code-based: include all relevant procedure, CPT, HCPCS, and device codes with the request and documentation. Applicable codes were updated effective 08/01/2025 (added CPT 0951T–0955T); verify plan-specific prior authorization rules and code edits prior to submission.

Include all relevant CPT/HCPCS codes and device descriptors when requesting prior authorization (e.g., L8690, L8691, L8694, L8692, 0951T–0955T, 92590–92595, S0618, V50xx series).
Check the member’s specific benefit, state fee schedule, and prior-authorization portal for code-level requirements and edits.

Documentation Required

Prior trial recommended before implantation

A trial with a non-implantable bone conduction device (headband/softband or adhesive-held BCHA) is recommended and should be documented before permanent implantation when clinically appropriate, especially for children and for adults to demonstrate benefit. For children, use of a headband/softband is appropriate until temporal bone maturity permits implantation.

Clinical Background and Evidence Summary

Background: wearable air‑conduction hearing aids are the standard treatment when hearing loss cannot be medically or surgically corrected. Bone‑anchored and semi‑implantable electromagnetic devices are alternatives for patients who are not candidates for air‑conduction aids.

Definitions and Device Types

inv-47: Conductive Hearing Loss — definition.

DefinitionHearing loss due to inefficient conduction through the outer ear canal, tympanic membrane, or ossicles of the middle ear

Clinical implicationOften amenable to medical or surgical correction

Audiologic featureTypically presents as a reduction in sound level or inability to hear faint sounds

inv-48: Degree of Hearing Loss / Sensorineural Hearing Loss — ranges and definitions.

Normal to Profound rangesNormal: −10 to 15 dBHL; Slight: 16–25 dBHL; Mild: 26–40 dBHL; Moderate: 41–55 dBHL; Moderately Severe: 56–70 dBHL; Severe: 71–90 dBHL; Profound: ≥91 dBHL

Sensorineural hearing loss (SNHL)Caused by inner ear (cochlea) or neural pathway damage; usually not correctable medically or surgically

Policy Changes and History

2026-04-01policy_retirementLatest

Policy retired for Louisiana plan membership; Louisiana members were disenrolled effective April 1, 2026.

2025-08-01coding_update

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

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS052LA.O

Change TypeRetirementcoding update

Effective DateAugust 1, 2025 - March 31, 2026

Next Review DateN/A

Key ActionDocument audiometric evidence of significant hearing loss (>20 dB PTA 250–2000 Hz) from an otologist and a hearing aid provider when requesting coverage.

SourceLink

On This Page

Device selection is consistent with patient anatomy, preference, and benefit-risk considerations (eg, transcutaneous vs percutaneous based on desire to avoid abutment and on osseointegration candidacy).

clinical judgment with evidence consideration

Comparative evidence limited; consider complication profiles and aesthetics

Bone-anchored and partially implantable bone-conduction devices: Devices cleared by the FDA with labeled indications (BAHA/Bonebridge/Osia/Baha Attract, etc.) are supported for conductive/mixed loss and select SSD cases; evidence shows improvements in thresholds, speech in noise, and quality of life compared with no intervention.match device labeling

AAO-HNS considers BCHD appropriate for conductive/mixed loss and select SSD; evidence lacks RCTs comparing devices

PTA bone-conduction ≤45 dB HL; age indications include BP100 for children ≥5 (Softband/headband options available for younger ages)

Example: Osia / Osia2PTA bone-conduction ≤55 dB HL; age ≥12 for implantation per device labeling

Example: ADHEAR (non-implantable)PTA bone-conduction ≤25 dB HL; indicated for patients of all ages for conductive loss or SSD

Age considerationsDevice-specific minimum ages vary (examples: BAHA/Baha Attract ≥5 years; Bonebridge and Osia ≥12 years; some non-implantable devices for all ages)

inv-27: Pure tone average (PTA) bone-conduction threshold — device-specific examples (<=25 dB HL ADHEAR; <=45 dB HL BAHA/Bonebridge; <=55 dB HL Osia/Osia2; up to 65 dB HL for certain SoundArc devices).

ADHEAR (non-implantable)PTA bone-conduction ≤25 dB HL

BAHA / Bonebridge (typical processors)PTA bone-conduction ≤45 dB HL (BP100/Bonebridge)

Osia / Osia2PTA bone-conduction ≤55 dB HL

SoundArc / SuperPower processorsPTA bone-conduction up to 65 dB HL for certain Cordelle II / SuperPower processors

Actionable guidanceMatch device PTA BC limits to patient BC PTA when considering candidacy

inv-28: Air-conduction threshold for normal hearing (contralateral ear in SSD) — <=20 dB HL (PTA at 0.5,1,2,3 kHz).

Normal hearing (contralateral ear for SSD indication)Pure tone average air-conduction (0.5, 1, 2, 3 kHz) ≤20 dB HL

Use in SSD candidacyContralateral ear AC PTA ≤20 dB HL required for BAHA, Bonebridge, Osia and similar SSD indications

Measurement frequenciesPTA calculated at 0.5, 1, 2, and 3 kHz per device labeling

Document trial dates, device type (softband/headband/adhesive), audiologic measures demonstrating benefit (sound-field thresholds, speech discrimination), and patient/caregiver-reported quality-of-life improvements.
For infants and young children, document use and improvement on validated developmental/auditory scales (e.g., Infant-Toddler Meaningful Auditory Integration Scale) when available.

Prior Authorization

Document FDA‑indicated selection criteria with prior authorization

Prior authorization requests must document that the patient meets device-specific FDA-indicated selection criteria (age limits, audiometric thresholds, speech recognition scores, and anatomic/clinical suitability) per the manufacturer/labeling.

Include device-specific FDA labeling criteria in the record (e.g., age ≥18 for some active middle ear implants; Bonebridge age ≥12; BAHA indications and bone-conduction thresholds).
Provide audiograms with PTA/BC and AC thresholds, word recognition scores, and description of middle ear anatomy as required by the device labeling.

Documentation Required

State‑specific eligibility, documentation, and equipment upgrades

State-specific eligibility and documentation rules apply. For EPSDT-eligible beneficiaries (under age 21) follow state rules requiring audiometric documentation from an ear specialist and a hearing aid provider. Equipment upgrades or changes in medical condition are treated as a new service and require the same documentation and prior authorization criteria as an initial request.

For Louisiana Medicaid and other state programs, verify state fee-schedule coverage (codes marked with * may not be covered) and any age-specific rules before submitting requests.
When requesting upgrades or replacements, submit current audiometric data, justification for upgrade, and evidence that member meets current device criteria.

Documentation Required

Document device type and device‑specific selection criteria (and note intraoral evidence limitation)

Document device-specific selection and clinical details: specify device type (percutaneous vs transcutaneous vs semi-implantable vs fully implanted vs intraoral), FDA labeling-based audiometric thresholds, and speech recognition performance. Note that intraoral bone conduction devices have insufficient quality evidence and may be considered unproven or not medically necessary.

Clearly state the proposed device model and implantation approach and include supporting FDA indication documents when applicable.
If proposing an intraoral device, include high-quality evidence; be aware that current evidence is insufficient and coverage may be denied as investigational.

Documentation Required

Document conservative amplification trials prior to implantation

Conservative amplification trials should be documented for adults who may be unable to benefit from conventional hearing aids. AAO‑HNS guidance supports documenting prior attempts with appropriately fit air-conduction or bone-conduction hearing aids before implanting active middle ear or bone-conduction devices.

Submit records of prior hearing aid fittings, electroacoustic evaluations, and documented lack of sufficient benefit from conventional amplification (including speech recognition measures).
For Bonebridge and some semi-implantable devices, document prior experience with appropriately fit air-conduction or bone-conduction aids as recommended in FDA labeling.

Implication for device selectionDegree of loss (dBHL) guides candidacy for air-conduction vs implantable or bone-conduction devices

inv-49: Bone Anchored Hearing Aids — definition and percutaneous/transcutaneous distinction.

DefinitionSurgically implanted systems that transmit sound via skull vibration to the inner ear (bone conduction)

ClassificationCan be percutaneous (abutment penetrating skin) or transcutaneous (magnetic coupling through intact skin)

IndicationsUsed for conductive or mixed hearing loss and select single-sided deafness cases per FDA labeling

inv-50: Semi-Implantable Electromagnetic Hearing Aids (SEHA) — definition.

DefinitionDevices with an implanted magnetic component in the middle ear and an external sound processor that transmits amplified signals to vibrate the ossicles

MechanismExternal processor converts sound to electrical signals transmitted to implanted magnet causing ossicular vibration

Regulatory classClassified by FDA as hearing aids (professional labeling specifies selection criteria)

inv-51: Percutaneous bone-anchored hearing aid — definition.

DefinitionA percutaneous bone conduction hearing aid involving surgical implantation of a titanium screw into the mastoid with an abutment that penetrates the skin to couple an external sound processor after osseointegration

CharacteristicRequires osseointegration period before external processor attachment

Example systemsTraditional BAHA/osseointegrated systems described in FDA clearances

inv-52: Transcutaneous bone conduction hearing aid — definition.

DefinitionA partially implantable bone conduction device using magnetic coupling where a subdermal magnetic implant transmits vibrations through intact skin to an external processor

CharacteristicDoes not require a percutaneous abutment; external processor rests on skin attracted by implanted magnet

ExamplesSophono Otomag, Cochlear Baha Attract, Bonebridge (transcutaneous) and Osia Systems (subdermal magnetic implants)

inv-53: Laser/light-based hearing aid (Earlens CHD) — definition.

DefinitionA behind-the-ear light-based processor paired with a tympanic membrane transducer that converts infrared light pulses into tympanic membrane vibrations

MechanismLight pulses transmitted from BTE processor to a custom tympanic transducer placed deep in ear canal

Device exampleEarlens Contact Hearing Device (CHD)

inv-54: Totally implanted middle ear system (e.g., Esteem) — definition.

DefinitionA fully implanted middle ear device comprising internal sensor, processor, and driver; does not use external microphone or speaker

Clinical noteStudies report functional gains but evidence limited by single-arm designs and variable adverse events

Device examplesEsteem, Carina (examples cited in systematic reviews)

inv-55: Intraoral bone conduction (IOBC) — definition example (SoundBite).

Definition exampleAn intraoral bone conduction prosthesis with an in‑mouth transducer transmitting sound via teeth/jaw to cochlea (eg, SoundBite)

Availability noteSoundBite manufacturing ceased and evidence quality is low; device not supported for routine coverage

IndicationDesigned for single-sided deafness by routing sound from affected side to functioning cochlea

inv-56: Light-driven contact hearing aid (CHA / Earlens) — definition.

DefinitionA light-driven contact hearing aid directly driving the tympanic membrane using a light‑driven transducer to extend amplification into higher frequencies (up to ~10 kHz)

ComponentsBTE light processor + tympanic membrane transducer placed in deep ear canal (Earlens CHD)

Evidence noteStudies show improvements in word recognition and functional gain but lack blinded concurrent controls

inv-57: Totally implantable middle ear implant (AMEI) — definition (Carina/Esteem).

DefinitionAn entirely implanted active middle ear implant providing mechanical stimulation of middle ear structures to treat SNHL or mixed loss (eg, Carina, Esteem)

EvidenceSingle-arm studies report functional gain and improved speech outcomes but with device failures and adverse events; higher‑quality comparative data lacking

Clinical implicationConsidered investigational/unproven in many contexts pending stronger evidence

inv-58: Bone-anchored hearing device (BAHD / BAHA / Bonebridge) — definition and indications.

DefinitionDevices that conduct sound via bone conduction using percutaneous or transcutaneous implants; sound processor couples to skull vibration

IndicationsIndicated for conductive or mixed hearing loss and select single‑sided deafness cases when within device PTA limits

VariantsIncludes percutaneous BAHA systems and transcutaneous systems such as Baha Attract, Bonebridge, Osia

inv-59: Symmetrical bone-conductive thresholds — definition (less than 10 dB average difference between ears).

DefinitionLess than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies

Use for bilateral fittingSymmetry criterion used to determine eligibility for bilateral BAHD/partially implantable devices

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

inv-60: Normal hearing (for SSD indication) — PTA air-conduction threshold <=20 dB HL (0.5,1,2,3 kHz).

Definition (Normal hearing for SSD)Pure tone average air‑conduction threshold of better than or equal to 20 dB HL measured at 0.5, 1, 2, and 3 kHz

Role in SSD indicationsRequired contralateral normal hearing threshold for BAHA, Bonebridge, Osia devices when indicated for single‑sided deafness

Measurement guidanceUse PTA at 0.5, 1, 2 and 3 kHz as specified in device labeling