Implantable Bone-Conduction and Bone-Anchored Hearing Prosthetic Devices

Policy Number: MA 1.019

Effective Date 11/1/2026

Policy

Individuals with unilateral or bilateral hearing loss may be considered medically necessary for semi-implantable or fully implantable bone-conduction (bone-anchored) hearing aids as an alternative to an air-conduction hearing aid when specific audiologic and medical criteria are met. These devices may be medically necessary for individuals with conductive or mixed hearing loss who also meet at least one of the following medical criteria:

• Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear;
• Chronic otitis externa or otitis media; OR
• Tumors of the external canal and/or tympanic cavity; OR
• Dermatitis of the external canal.

AND meet the following audiologic criteria:

• Pure tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (e.g., BCD and BCD10 devices), 55 dB (Otologics device), or 65 dB (Cordelle II device).

For bilateral implantation, individuals should meet the above audiologic criteria and have symmetrical conductive or mixed hearing loss, as defined by a difference between left and right bone-conduction thresholds of less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz; 4 kHz for BCD and BCD Pro, or less than 15 dB at individual frequencies.

An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal (CROS) hearing aid in individuals 5 years of age and older with single-sided sensorineural deafness and normal or near normal hearing in the other ear. The pure tone average and conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in members with bilateral sensorineural hearing loss, are considered investigational, as there is insufficient evidence of improved net health benefit associated with this procedure.

Policy Guidelines

In patients being considered for implantable bone-conduction (bone-anchored) hearing aids, bone quality and thickness should be assessed for adequacy to ensure implant stability. Additionally, individuals (or caregivers) must be given proper hygiene to prevent infection and ensure the stability of the implants and percutaneous abutments.

The degree of hearing loss per the American Speech–Language–Hearing Association (ASHA, 2018), the degree of hearing loss refers to the severity of an individual's hearing loss range in decibels (dB) in Table 1:

Table 1

Cross-References

• MP 1.023 Cochlear Implants
• MP 1.103 Semi-implantable and Fully Implantable Middle Ear Hearing Aid

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Hearing Loss

Hearing loss is described as conductive, sensorineural, or mixed, and can be unilateral or bilateral. Normal hearing detects sound at or below 20 decibels (dB). The American Speech–Language–Hearing Association has defined degree of hearing loss based on pure-tone average (greater than thresholds at 500 and 2000–4000 Hz): mild (21–40 dB), moderate (41–55 dB), severe (60–80 dB), and profound (greater than 80 dB). Pure-tone averages are calculated by averaging hearing sensitivities (i.e., the minimum volume that a patient can hear) at multiple frequencies (perceived as pitch), typically within the range of 0.25 to 8 kHz.

Sound amplification using an air-conduction (AC) hearing aid can provide benefit to patients with sensorineural or mixed hearing loss. Contralateral routing of signal (CROS) is a system in which a microphone on the affected side transmits a signal to an AC hearing aid on the normal or less affected side.

Treatment

External bone-conduction hearing devices function by transmitting sound waves through the bone to the ossicles of the middle ear. The external devices must be applied close to the temporal bone, with either a steel spring over the top of the head or a spring-loaded arm on a pair of spectacles. These devices may be associated with pressure headaches or soreness.

A bone-anchored implant system combines a vibrational transducer coupled directly to the skull via a percutaneous abutment that permanently protrudes through the skin from a small titanium implant anchored in the temporal bone. The system is based on osseointegration through which living tissue integrates with titanium in the implant over 3 to 6 months, conducting amplified and processed sound via the skull bone directly to the cochlea. The lack of intervening skin permits the transmission of vibrations at a lower energy level than required for external bone-conduction hearing aids. Implantable bone conduction hearing systems are primarily indicated for people with conductive or mixed sensorineural or conductive hearing loss. They may also be used with CROS as an alternative to an AC hearing aid for individuals with unilateral sensorineural hearing loss.

Partially implantable magnetic bone-conduction hearing systems, also referred to as transcutaneous bone-anchored systems, are an alternative to bone-conduction hearing systems that connect to bone percutaneously via an abutment. With this technique, acoustic transmission occurs transcutaneously via magnetic coupling of the external sound processor and the internally implanted device components. The bone-conduction hearing processor contains magnets that adhere externally to magnets implanted in shallow bone beds with the bone-conduction hearing implant. Because the processor adheres magnetically to the implant, there is no need for a percutaneous abutment to physically connect the external and internal components. To facilitate greater transmission of acoustics between magnets, skin thickness may be reduced to 4 to 5 mm over the implant when it is surgically placed.

Regulatory Status

Several implantable bone-conduction hearing systems have been approved by the U.S. Food and Drug Administration for marketing through the 510(k) process (Table 2).

Product codes: MAH, LXB

Table 2. Implantable Bone-Conduction Hearing Systems Approved by the FDA

• Patients who have conductive or mixed hearing loss and can still benefit from sound amplification;
• Patients with bilaterally symmetric conductive or mixed hearing loss may be implanted bilaterally;
• Patients with sensorineural deafness in one ear and normal hearing in the other (i.e., single-sided deafness);
• Patients who are candidates for an AC CROS hearing aid but who cannot or will not wear an AC CROS device.

Baha sound processors can be used with the Baha^® Softband™. With this application, there is no implantation surgery. The sound processor is attached to the head using a hard or soft headband. The amplified sound is transmitted transcutaneously to the cochlea via the bones of the skull. In 2002, the Baha Softband™ was cleared for marketing by FDA for use in children younger than 5 years. Because this application has no implanted components, it is not addressed in this evidence review.

The FDA also cleared 3 partially implantable magnetic bone-conduction devices for marketing through the 510(k) process (Table 3). Partially Implantable Magnetic Bone-Conduction Devices Approved by the FDA.

Table 3. Partially Implantable Magnetic Bone-Conduction Devices Approved by the FDA

The SoundBite™ Hearing System (Sonitus Medical, San Mateo, CA) is an intraoral bone-conduction hearing prosthesis that consists of a behind-the-ear microphone and an in-the-mouth hearing device. In 2011, it was cleared for marketing by FDA through the 510(k) process as a bone-conduction hearing aid. However, the manufacturer (Sonitus Medical) ceased operations in 2015.

FDA product code (for bone-anchoring hearing aid): LXB. FDA product code (for implanted bone-conduction hearing aid): MAH.

Rationale

Summary of Evidence

For individuals who have conductive or mixed hearing loss who receive an implantable BAHA with a percutaneous abutment or a partially implantable BAHA with transcutaneous coupling to the sound processor, the evidence includes randomized controlled trials that have reported pre-post differences in hearing parameters after treatment with BAHAs. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. No prospective trials were identified. Observational studies reporting on within-subject changes in hearing have generally demonstrated improvements with the devices. Given the objective measures of hearing and the largely invariant natural history of hearing loss in individuals who would be eligible for an implantable bone-conduction device, the demonstrated improvements in hearing after device placement can be attributed to the device. Studies of partially implantable BAHAs have demonstrated improvements in hearing. The single-arm studies have shown improvements in hearing in the device-aided state. No direct comparisons other than within-subject comparisons have been made between alternative treatments. For individuals unable to wear conventional hearing aids, they may be the alternative treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have unilateral sensorineural hearing loss who receive a fully or partially implantable BAHA with either contralateral routing of signal or bone-conduction hearing aid, the evidence includes randomized controlled trials, multiple prospective and retrospective case series, and a systematic review. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. Single-arm case series, with sample sizes ranging from small to large, have generally reported improvements in patient-reported speech intelligibility, speech perception in noise, and satisfaction with bone-conduction devices with contralateral routing of the signal. However, studies using contralateral routing of signal found no evidence of improvement in speech recognition or hearing localization. The single RCT included in the systematic review was a pilot study enrolling only 10 patients and, therefore, does not provide definitive evidence. Quality RCTs on BAHA for unilateral sensorineural hearing loss are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

• Conductive Hearing Loss refers to a form of hearing loss when sounds cannot get through the middle ear.
• Hearing Aid is any external device that does not produce an acoustic signal that directly stimulates the auditory nerve. Examples of hearing aids are devices that produce acoustic signals by stimulating the ossicles of the middle ear or devices that produce sound through stimulating/vibrating the ossicles of the middle ear. Hearing aids that produce sound through the output arm of the sound vibrator, devices such as auditory implants that produce sound through an output arm that directly stimulates the auditory nerve, are not considered to be hearing aids.
• Mixed Hearing Loss is when conductive and sensorineural hearing loss are both present.
• Ossicular refers to any small bone, especially one of the three bones of the ear.
• Sensorineural Hearing Loss refers to a form of hearing loss when sound is conducted normally through the external and middle ear and damage of or defect in the inner ear or auditory nerve results in hearing loss. The loss is measured in decibels and may be described as mild, moderate, severe, or profound.
• Subcutaneous refers to beneath the skin.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

References

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Policy History

• MA 1.019
• 7/18/2025 Creation of Medicare only policy.