Implantable Bone-Conduction and Bone-Anchored Hearing Aids

POLICY NUMBER

A.7.01.03

DESCRIPTION

Sensorineural, conductive, and mixed hearing loss may be treated with various devices, including conventional air-conduction or bone-conduction external hearing aids. Air-conduction hearing aids may not be suitable for patients with chronic middle ear and ear canal infections, atresia of the external canal, or an ear canal that cannot accommodate an ear mold. Bone-conduction hearing aids may be useful for individuals with conductive hearing loss, or (if used with contralateral routing of signal), for unilateral sensorineural hearing loss. Implantable, bone-anchored hearing aids (BAHAs) that use a percutaneous or transcutaneous connection to a sound processor have been investigated as alternatives to conventional bone-conduction hearing aids for patients with conductive or mixed hearing loss or for patients with unilateral single-sided sensorineural hearing loss.

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 the degree of hearing loss based on pure-tone average detection thresholds as mild (20 to 40 dB), moderate (40 to 60 dB), severe (60 to 80 dB), and profound (≥80 dB). Pure-tone average is calculated by averaging hearing sensitivities (ie, the minimum volume that a patient hears) 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 though 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.

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

Implantable Bone-Conduction Hearing Systems Approved by the U.S. Food and Drug Administration

The FDA cleared the majority of these systems for use in children age 5 years and older and adults for the following indications:

• 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 air-conduction contralateral routing of signals (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 the FDA for use in children younger than 5 years. As this application has no implanted components, it is not addressed in the policy.

The most recently cleared Osia™2 system may be used by adults and children 12 years of age and older with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness.

The FDA also cleared 3 partially implantable magnetic bone-conduction devices for marketing through the 510(k) process (see table below).

Partially Implantable Magnetic Bone-Conduction Devices Approved by the FDA

The SoundBite™ Hearing System (Sonitus Medical, San Mateo, CA) is an intraoral bone-conducting 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 the FDA through the 510(k) process for indications similar to the Baha. However, the manufacturer, Sonitus Medical, closed in 2015.

Note: See the  Cochlear Implants policy, for the treatment of severe to profound deafness.

POLICY

NOTE: Implantable bone-conduction and bone-anchored hearing aids are subject to the Member's contract benefits and/or exclusions. If a Member's contract excludes hearing aids, unless there is a provision that specifically distinguishes between bone and air conduction hearing aids, this policy is not applicable, as the Member's contract will supercede this medical policy.

Unilateral or bilateralfully or partially implantable bone-conduction (bone-anchored) hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in individuals 5 years of age and older with conductive or mixed hearing loss who also meet at least one of the following criteria: 

• Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear;

• Chronic external otitis or otitis media;

• Tumors of the external canal and/or tympanic cavity;

• Dermatitis of the external canal;

AND meet the following audiologic criteria:

• A pure-tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device) or 65 dB (Cordele II device).

For bilateral implantation, individuals should meet the above audiologic criteria and have symmetrically conductive or mixed hearing loss as defined by a difference between left- and right-side bone-conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz (4kHz for OBC and Ponto 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 CROS hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air-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 individuals with bilateral sensorineural hearing loss, are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy should not be used in lieu of the Member's specific benefit plan language.

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

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/24/2007: Policy added.

9/19/2007: Code reference section updated. ICD-9 2007 revisions added to policy.

11/15/2007: Policy approved by MPAC.

10/7/2008: Policy reviewed, no changes.

3/15/2010: Code Reference section updated. New HCPCS code L8692 added to covered table. 

04/21/2010: Policy description updated regarding FDA approval of devices. The medically necessary policy statements were revised to add “5 years of age and older” to be consistent with FDA-approved labeling. “Sensorineural” added to the second statement. The intent of the policy statements unchanged. FEP verbiage added to the Policy Exceptions section. 

03/09/2011: Added new HCPCS code L8693 to the Code Reference section.

04/25/2011: Audiologic criteria moved from the policy guidelines to the policy statement.

03/02/2012: Added policy statement to indicate that partially implantable bone conduction hearing systems using magnetic coupling for acoustic transmission are considered investigational. Other policy statements unchanged.

04/04/2013: Policy reviewed; no changes.

03/14/2014: Policy reviewed; description updated regarding FDA approval of available devices. Added "The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz" to the medically necessary policy statement. Removed deleted ICD-9 Code 389.2 from the Code Reference section.

02/16/2015: Policy description updated regarding hearing loss and devices. Added "(4kHz for OBC and Ponto Pro)" to the policy statement regarding bilateral implantation. First investigational statement updated to change "bone-conduction" to "implantable bone-conduction" and remove "including bilateral implantation." It previously stated: Other uses of bone conduction (bone-anchored) hearing aids, including bilateral implantation or use in patients with bilateral sensorineural hearing loss is considered investigational. Second investigational statement updated to change "partially implantable bone conduction" to "partially implantable magnetic bone-conduction." Policy guidelines updated regarding patient characteristics for implantable bone-conduction hearing aids.

08/28/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 01.24.

05/31/2016: Policy number A.7.01.03 added. Policy Guidelines updated to add medically necessary and investigative definitions.

08/11/2016: Policy description updated regarding devices. First policy statement updated to add partially implantable bone-conduction (bone-anchored) hearing aids as medically necessary when certain criteria are met. Removed investigational statement for partially implantable devices.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes H90.A21, H90.A22, H90.A31, and H90.A32.

03/01/2017: Policy description updated regarding devices. Policy statements unchanged.

12/22/2017: Code Reference section updated to add new 2018 HCPCS code L8694. Revised description for HCPCS code L8691.

02/28/2018: Policy reviewed; no changes.

05/25/2018: Medical policy link updated in policy description.

03/19/2019: Policy description updated regarding devices. Policy statements unchanged.

03/09/2020: Policy description updated regarding devices. Policy statements unchanged.

04/06/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/13/2021: Code Reference section updated to add new CPT codes 69716, 69719, 69726, and 69727, effective 01/01/2022. Revised code descriptions for CPT codes 69714 and 69717.

04/11/2022: Policy description updated regarding devices. Policy statements unchanged.

12/19/2022: Code Reference section updated to add new CPT codes 69728, 69729, and 69730. Revised the description for CPT codes 69716, 69717, 69719, 69726, and 69727. Effective 01/01/2023.

03/16/2023: Policy description updated regarding devices. Policy statements and Policy Guidelines updated with minor wording changes. Code Reference section updated to remove deleted CPT codes 69715 and 69718.

03/19/2024: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

04/10/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.03

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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