Hearing Aids
Coverage policy for hearing aid devices (air conduction, bone conduction, and middle ear devices) administered by Cigna; governs medical necessity, repair/replacement, and coding guidance for members whose benefit plans permit hearing aid coverage.
Removed policy statements for air conduction hearing aids
Removed policy statements for initial and replacement batteries
Annual review entries noting no clinical policy statement changes for dates 6/15/2025 and 5/15/2024
Coverage and Medical Necessity Criteria
General Hearing Aid Medical Necessity
An FDA-approved hearing aid device is considered medically necessary for ANY of the following:
When one of these is met, FDA‑approved air conduction, partially implantable middle ear, or bone conduction devices with advanced signal processing are considered medically necessary.
When one of these is met, FDA‑approved air conduction, partially implantable middle ear, or bone conduction devices with advanced signal processing are considered medically necessary.
When one of these is met, FDA‑approved air conduction, partially implantable middle ear, or bone conduction devices with advanced signal processing are considered medically necessary.
Partially Implantable Bone Conduction Hearing Aids
Considered medically necessary when ALL of the following are met:
Examples include Vibrant Soundbridge and Maxum™
Bone Conduction Hearing Aids
Bone conduction hearing aid devices are considered medically necessary for the following distinct scenarios:
Examples: Ponto, Cochlear Baha Connect, Baha Attract, Sophono, Bonebridge, Osia
Devices include Ponto Systems, Cochlear Osia, Bonebridge, Osia/Osia 2
Examples and device-specific thresholds: percutaneous abutment devices, magnetic coupling systems (Baha Attract, Sophono), Bonebridge, Osia
Device-specific medical necessity criteria
Covered when ALL of the following device-specific FDA indication criteria are met (examples pulled from device approvals):
See device-specific labeling for exact age criteria
Exact thresholds depend on specific processor/model and FDA labeling
Refer to device labeling for exact symmetry criteria
Many device approvals recommend prior hearing aid trial (see Bonebridge, Osia, ADHEAR labeling)
Includes CT imaging requirements and hygiene/maintenance considerations per device labeling
Esteem candidate selection
Covered when ALL of the following Esteem device indications are met:
From Esteem FDA PMA labeling (P090018)
Semi-implantable device candidate selection
Covered when ALL of the following are met for semi-implantable electromagnetic systems:
Electromagnetic semi‑implantable devices are contraindicated for conductive hearing loss, retrocochlear or central auditory disorders, active middle ear infection, tympanic membrane perforations with recurrent infections, disabling tinnitus, or prior middle ear surgery.
Repair and Replacement
Repair and/or replacement of a medically necessary hearing aid device not under warranty are considered medically necessary as follows:
Repair is applicable when device is under the repairable condition and not covered by warranty.
Replacement applies when device cannot be made functional by repair and is not under warranty.
Fully implantable middle ear hearing aids (for example, the Esteem® device) and non‑implantable intraoral bone conduction systems (for example, the SoundBite™ Hearing System) are listed in this policy as experimental, investigational, or unproven and are not considered established therapies. The policy cites limited and primarily small, nonrandomized studies and notes gaps in long‑term safety, durability, and comparative effectiveness data for fully implantable systems. Providers seeking coverage should be aware that these devices are not supported as standard medical necessity options in this policy and, where requested, authorization should reference the available regulatory summaries and the limited clinical evidence base.
Middle ear semi‑implantable electromagnetic hearing aids are contraindicated for patients with conductive hearing loss, retrocochlear or central auditory disorders, active middle ear infection, tympanic membrane perforations with recurrent infections, disabling tinnitus, or prior middle ear surgery. These contraindications may render the device excluded for a given member and should be documented in preoperative evaluation to avoid authorization denials.
The intraoral SoundBite™ bone conduction system has received FDA 510(k) clearance for use in adults and is intended for individuals aged 18 years or older with single‑sided deafness or certain conductive losses. Published clinical data are limited (nonrandomized cohorts, relatively small samples, and short follow‑up), and the evidence does not provide definitive conclusions regarding long‑term safety or comparative effectiveness versus other BAHA options. Because of these limitations, intraoral systems are treated cautiously in coverage determinations and broader use may be restricted pending stronger data.
Explicit exclusions and contraindications that may trigger non‑coverage include: conductive hearing loss where a device is contraindicated, retrocochlear or central auditory disorders, active middle ear infection, tympanic membrane perforations with recurrent infections, disabling tinnitus, prior middle ear surgery, chronic middle ear disease, Meniere disease, disabling vertigo, fluctuating hearing loss, keloid formation, and sensitivity to device component materials. These conditions should be assessed and documented as part of any prior authorization or preoperative evaluation.
As part of the annual review, the policy removed previous statements relating to coverage of air conduction hearing aids and to initial and replacement batteries. The revision note explicitly documents these removals but does not change the other clinical policy statements; providers should consult the member’s benefit plan for current details on air conduction device and battery coverage.
Hearing aids are unlikely to provide meaningful benefit for individuals with poor word (speech) discrimination. The policy uses a speech discrimination threshold of <60% as the cutoff below which hearing aids are generally not expected to be beneficial; such results often reflect neural degeneration and should prompt consideration of alternative management rather than routine provision of amplification.
Bone‑anchored hearing aid (BAHA/BAHD) devices have demonstrated benefit for conductive and mixed losses and for single‑sided deafness in many case series and cohort studies, but the policy notes that the evidence does not support use of BAHA devices for bilateral sensorineural hearing loss. Published literature for some indications is limited to case series and small cohorts, and clinical outcomes for bilateral SNHL have not been established.
Although the Esteem® fully implantable device has FDA PMA approval with specific adult indications, the policy highlights insufficient evidence to support widespread clinical use. Long‑term safety, device durability (including the need for surgical battery replacement), and demonstrated advantages over conventional hearing aids are inadequately characterized in the literature; reported adverse events and the need for potential reoperation underscore the limited evidence base and residual safety concerns.
Billing Codes and Regulatory Identifiers
| 69799 | Unlisted procedure, middle ear |
| 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 |
| K172460 | ADHEAR system FDA 510(k) approval identifier |
| K183373 | Bonebridge FDA 510(k) approval identifier |
| K190589 | Osia System FDA 510(k) approval identifier |
| K191921 | Osia 2 System FDA 510(k) approval identifier |
| K984162 | BAHA 510(k) identifier cited |
| K021837 | Branemark BAHA 510(k) summary for unilateral SNHL reference |
| K100649 | SoundBite Hearing System 510(k) identifier |
| K110831 | SoundBite Hearing System 510(k) identifier |
| P090018 | Esteem PMA approval identifier |
Provider Requirements, Prior Authorization, and Documentation
Provider action checklist
Coverage determinations require review of the member's applicable benefit document, applicable laws/regulations, and relevant Coverage Policy. Claims submitted for services without covered codes under the applicable Coverage Policy will be denied as not covered.
- Confirm member's benefit plan document for coverage details — prior authorization requirements and covered codes vary by customer plan.
- Claims for services not accompanied by covered CPT/HCPCS codes will be denied.
Prior Authorization Required (when applicable)
Prior authorization may be required and depends on the member's benefit plan. When prior authorization is required, documentation must demonstrate the patient meets device-specific FDA indication criteria (e.g., age, audiometric thresholds, symmetry, prior hearing aid trial).
- Before requesting authorization, confirm whether the member's plan requires prior authorization for the specific device or service.
- When seeking prior authorization, include documentation that the patient meets device-specific FDA criteria (age limits, PTA/BC thresholds, symmetry criteria, SSD criteria where applicable).
- For devices with explicit FDA indications (e.g., Bonebridge, Osia, ADHEAR, BAHA/BAHD, Esteem), show how the patient meets those indications.
Device-specific candidacy documentation
Device candidacy must be documented to match device-specific FDA labeling (age, type and degree of hearing loss, PTA/BC thresholds, symmetry between ears, prior experience with conventional aids). Provide objective audiometric data and prior-device trial documentation.
- Include pure tone averages (PTA) and bone conduction (BC) thresholds measured at recommended frequencies (0.5, 1, 2, 3 kHz) and speech discrimination scores where applicable.
- Document symmetry criteria (e.g., <10 dB average BC difference or <15 dB at individual frequencies when required).
- Document prior experience with appropriately fitted air conduction or bone conduction hearing aids (minimum 30 days where specified by device labeling).
Device regulatory references
Device regulatory status and specific FDA references should be included with authorization requests and medical records when relevant.
- Reference the applicable FDA 510(k) or PMA summary for the device being requested (examples in References: Bonebridge K183373; ADHEAR K172460; Branemark BAHA K984162/K021837; Esteem PMA P090018).
- Include manufacturer labeling or FDA summary that documents intended use and the specific indications/contraindications.
- Provide links or citations to FDA summaries if available for quick reviewer verification.
Contraindications may lead to non-coverage
Certain contraindications noted in device labeling may lead to non-coverage. If contraindications are present, document rationale for device selection or consider alternative covered interventions.
- Contraindications that may trigger denial include: conductive hearing loss for devices intended for sensorineural loss, retrocochlear or central auditory disorders, active middle ear infection, tympanic membrane perforations with recurrent middle ear disease.
- For fully implantable devices (e.g., Esteem), contraindications also include history of chronic middle ear disease, Meniere disease, disabling tinnitus/vertigo, fluctuating hearing loss, central auditory disorder, keloid tendency, or material sensitivities.
Repair vs Replacement
Repair is considered medically necessary when the current device is nonfunctional, inadequate function interferes with activities of daily living, and repair is expected to restore full function per manufacturer definition. Replacement is considered when the device is non-repairable.
- Document warranty status, assessed reparability, and that repair is expected to restore function.
- If replacement is requested, document that repair was attempted or that the device is non-repairable per manufacturer/service evaluation.
Recommend trial of conventional hearing aids before implant
Recommendation and prior hearing aid trial: many device approvals and labeling recommend prior experience with appropriately fitted air conduction or bone conduction hearing aids before implantation. Document trial duration and fitting details.
- Provide evidence of a trial with appropriately fitted air conduction or bone conduction hearing aids (some devices specify a minimum 30-day trial).
- If a trial was not possible or tolerated, document reasons (e.g., intolerance, contraindication, anatomical/medical reasons).
Removal noted
Revision note: policy statements for air conduction hearing aids and initial/replacement batteries were removed in prior revision. Be aware these removed statements may affect expectations for documentation and coverage — rely on the member's benefit plan document for current coverage specifics.
- Removed statements include: coverage policy language specific to air conduction hearing aids and policy language regarding batteries.
- Always confirm current coverage in the customer's benefit plan document since removed policy text may no longer reflect plan-specific benefits.
Clinical Background and Evidence Summary
Hearing loss may be conductive, sensorineural, or mixed, and audiometric testing (including pure‑tone average and speech discrimination) is used to characterize severity and guide device selection. Pure‑tone averages are typically calculated from thresholds at 500, 1000, and 2000 Hz, and speech discrimination scores help predict likely benefit from amplification.
A Personal Sound Amplification Product (PSAP) is defined by the FDA as an electronic product intended for non‑hearing‑impaired consumers to amplify environmental sounds (for example, for hunting or bird watching). PSAPs are not considered medical devices and are not intended to diagnose, treat, or compensate for hearing impairment.
The pure‑tone average (PTA) is a summary audiometric measure typically calculated from thresholds at 500, 1000, and 2000 Hz (sometimes including 3000 Hz) and is used to classify hearing loss severity and candidacy for amplification.
Air conduction hearing aids deliver sound through the external ear canal and middle ear. Common form factors include behind‑the‑ear (BTE), in‑the‑ear (ITE), in‑the‑canal (ITC), and completely‑in‑canal (CIC) devices; they are FDA Class I devices and are appropriate for a broad range of hearing loss severities depending on style and technology.
Bone‑anchored hearing aids (BAHA/BAHD) transmit sound through the skull to the cochlea via a titanium implant and abutment or via magnetic/transcutaneous coupling. These systems are FDA Class II devices and are primarily indicated for conductive and mixed hearing loss, and in selected cases for unilateral sensorineural loss.
Middle ear implants (MEIs) are partially or fully implantable devices that use a transducer to directly move middle or inner ear structures (for example, the ossicular chain) to amplify sound. They are regulated as FDA Class III devices and include both semi‑implantable electromagnetic systems and fully implantable piezoelectric systems.
The Esteem® device is a fully implantable piezoelectric middle ear hearing system consisting of an implanted sound processor, sensor, and driver that uses the natural ear as a microphone. It is FDA PMA approved for selected adult patients meeting specific audiometric and anatomic criteria.
Examples of active middle ear implants include the Vibrant Soundbridge and other semi‑implantable devices that couple a transducer to ossicular or middle ear structures to improve hearing thresholds and speech perception in appropriately selected patients.
Bone‑anchored and bone conduction systems encompass a range of devices that transmit sound via bone conduction, including percutaneous abutment systems and transcutaneous magnetic coupling systems, offering alternatives when conventional air conduction hearing aids are precluded by anatomy or chronic middle ear disease.
Policy Revision History
Removed policy statements for air conduction hearing aids and for initial and replacement batteries as noted in Revision Details.
Annual review completed with no clinical policy statement changes.
Annual review completed with no clinical policy statement changes.
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