Implantable Bone Conduction and Bone-Anchored Hearing Aids Policy Number: PG0218 ADVANTAGE | ELITE | HMO Last Review: 08/09/2021

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO GUIDELINES  This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will supersede this general policy when group supplementary plan document or individual plan decision directs otherwise.  Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards.  This medical policy is solely for guiding medical necessity and explaining correct procedure reporting used to assist in making coverage decisions and administering benefits.

SCOPE X Professional _ Facility

DESCRIPTION Conductive Hearing Loss occurs when sound is not conducted efficiently through the outer ear canal to the eardrum and the tiny bones (ossicles) of the middle ear. Conductive Hearing Loss usually involves a reduction in sound level or the ability to hear faint sounds. This type of hearing loss can often be corrected medically or surgically.

A partial or total 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 a period of 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/conductive hearing loss. They may also be used with contralateral routing of signal (CROS) as an alternative to an air conduction hearing aid with CROS for individuals with unilateral sensorineural hearing loss.

The bone-anchored hearing aid (BAHA), also called temporal bone osseointegrated implant, is an auditory prosthetic which can be surgically implanted. The BAHA uses the skull as a pathway for sound to travel to the inner ear. For people with conductive losses, the BAHA bypasses the external auditory canal and middle ear, stimulating the functioning cochlea.

The BAHA system is composed of three main components; . An internal titanium fixture that is surgically anchored to the skull in an area behind the ear . An external abutment that is connected to the implant at the time of surgery . An external sound processor that is snapped on to the abutment

For people with unilateral hearing loss, the BAHA uses the skull to conduct the sound from the deaf side to the side with the functioning cochlea. The BAHA uses the skull as a pathway for sound to travel to the inner ear. The sound processor vibrates the implant, which in turn vibrates the temporal bone. That vibration is then transmitted through

PG0218 – 08/09/2021 other bones to the cochlea of the opposite ear, where it creates the sensation of sound. BAHA is intended for use by members who have conductive or mixed 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.

Children under the age of five wear the BAHA device on a headband. The BAHA can be fit on a soft band as soon as the hearing loss has been diagnosed, reducing the auditory deprivation experienced by the child. The soft band, along with the headband, work like the conventional bone conductor. A BAHA can be worn on a soft band until the implant surgery is scheduled and the child is over the age of five as FDA approved.

POLICY HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Implantable Bone Conduction and Bone-Anchored Hearing Aids, procedures 69710, 69711, 69714, 69715, 69717, 69718, L8690, L8691, L8692, L8693, require prior authorization for all product lines.

COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Bone-anchored hearing aids, fully or partially, are considered medically necessary devices for members with unilateral or bilateral conductive or mixed hearing loss and can still benefit from sound amplification. It is indicated for members suffering from unilateral, single-sided deafness with appropriate hearing level in contralateral ear and members with bilaterally symmetric conductive or mixed hearing loss. Coverage is approved when any of the following conditions and all of the audiologic criteria is met (age consistent with the device-specific FDA indication): 1. Congenital or surgically induced malformations of the external ear canal or middle ear such as aural atresia; or 2. Tumors of the external ear canal and/or tympanic cavity; or 3. Severe chronic external otitis or otitis media; or 4. Hearing loss secondary to otosclerosis in persons who cannot undergo stapedectomy; or 5. Dermatitis of the external ear, including hypersensitivity reactions to ear moulds used in air conduction hearing aids; or 6. Other conditions in which an air-conduction hearing aid is contraindicated.

Audiologic Criteria: 1. 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) [based on each manufacturer's published technical specifications]; and 2. Speech discrimination score better than 60%.

For bilateral implantation, members 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 (4 kHz 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 contralateral routing of signal hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the opposite ear.

Implants for children under the age of five (5) years are not FDA approved and are non-covered. As an alternative for children under the age of five (5) years old, Paramount will approve a soft band bone conducting hearing aid

PG0218 – 08/09/2021 (L8692) if the above criteria are met. The sound processor is attached to the head using either a hard or a soft headband. The amplified sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea (e.g., Baha Headband, Baha Softband, ADHEAR).

REGULATORY STATUS Several implantable bone-conduction hearing systems have been approved by the U.S. Food and Drug Administration (FDA) for marketing through the 510(k) process.  Baha® Auditory Osseointegrated Implant System (Cochlear Americas)  BA310 Abutment, BIA310 Implant/Abutment cleared December 2018 (K182116)  Baha 5 Power Sound Processor cleared May 2016 (K161123)  Baha 5 Super Power Sound Processor cleared March 2016 (K153245)  Baha® 5 Sound Processor cleared March 2015 (K142907)  Baha® Attract System cleared November 2013 (K131240)  Baha® Cordelle II cleared July 2015 (K150751) and April 2008 (K080363)  Baha Divino® cleared August 2004 (K042017)  Baha Intenso® (digital signal processing) cleared August 2008 (K081606)  Baha® 4 (upgraded from the BP100) cleared September 2013 (K132278)  Cochlearâ„¢ Osiaâ„¢2 System cleared December 2019 (K191921)  OBC Bone-Anchored Hearing Aid System (Oticon Medical) cleared November 2011 (K112053)  Ponto Bone-Anchored Hearing System (Oticon Medical) cleared September 2012 (K121228)  Ponto 4 cleared May 2019  Ponto 3, Ponto 3 Power and Ponto 3 SuperPower cleared September 2016 (K161671)

The FDA also cleared 3 partially implantable magnetic bone-conduction devices for marketing through the 510(k) process.  Bonebridge by MED-EL cleared March 2019 (K183373)  Otomag® Bone-Conduction Hearing System by Medtronic (Formerly Sophono) cleared November 2013 (K132189)  Cochlear Baha® 4 Sound Processor by Cochlear Americas cleared October 2012 (K121317)

REPLACEMENT OF COMPONENTS Replacement of components or upgrades to existing osseointegrated hearing devices are covered when all of the following criteria are met:  Physician documentation that the patient has been compliant with use of the devices and will continue to benefit from use of the device; and  The current component or processor was being used daily until the malfunction occurred; and  The current component or processor is no longer functional and cannot be repaired; and  There is no evidence to suggest that the device has been lost, abused or neglected; and  The replacement is not being requested solely for better technology or improved aesthetics; and  When there is documentation that a change in the member’s condition makes the present unit non- functional and improvement is expected with a replacement unit. Replacement of components or upgrades to existing osseointegrated hearing devices are not covered when:  The medically necessary criteria for replacement parts or upgrades specified above are not met; or  When requested for convenience or aesthetics; or  Transcutaneously worn hearing aids.

EXCLUSIONS  Implantable bone-conduction (bone-anchored) hearing aids are excluded from coverage when qualifying criteria are not met.  Insufficient bone volume and bone quality to support successful implant placement (skull bone quality and thickness should be assessed for adequacy to ensure implant stability).  Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in members with bilateral sensorineural hearing loss, are considered investigational.

PG0218 – 08/09/2021  Members and/or caregivers who are unable to perform the hygienic activities necessary to maintain the abutment/skin interface of the bone conduction hearing aid. (members (or caregivers) must be able to perform proper hygiene to prevent infection and ensure the stability of the implants and percutaneous abutments).  Fully implantable middle ear hearing aid (e.g., Esteem) is considered investigational.  Non-implantable, intraoral bone conduction hearing aids are considered investigational.

Note: Implantable Bone Conduction and Bone-Anchored Hearing Aids (e.g., BAHA Bone-anchored hearing aids, transcutaneous soft band bone conducting hearing aids) are considered hearing aids. There may be specific member benefit language addressing coverage of hearing aids. Andy specific contract language supersedes medical policy. Unless otherwise specified, the contract language addressing coverage of hearing aids applies to both bone-conduction hearing aids and externally worn air-conduction hearing aids.

CODING/BILLING INFORMATION The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in this clinical policy are for informational purposes only. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. HCPCS CODES L8690 Auditory osseointegrated device, includes all internal and external components L8691 Auditory osseointegrated device, external sound processor, replacement Auditory osseointegrated device, external sound processor, used without osseointegration, L8692 body worn – includes headband or other means of external attachment L8693 Auditory osseointegrated device abutment, any length, replacement only L8694 Auditory osseointegrated device, transducer/actuator, replacement only, each CPT CODES Implantation or replacement of electromagnetic bone conduction hearing device in temporal 69710 bone 69711 Removal or repair of electromagnetic bone conduction hearing device in temporal bone Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to 69714 external speech processor/cochlear stimulator; without mastoidectomy Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to 69715 external speech processor/cochlear stimulator; with mastoidectomy Replacement (including removal of existing device), osseointegrated implant, temporal bone, 69717 with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy Replacement (including removal of existing device), osseointegrated implant, temporal bone, 69718 with percutaneous attachment to external speech processor/cochlear stimulator; with mastoidectomy Paramount reserves the right to review and revise our policies periodically when necessary. When there is an update, we will publish the most current policy to https://www.paramounthealthcare.com/services/providers/medical-policies/ .

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 03/30/2009 Date Explanation & Changes 06/01/10  Updated 10/24/14  Policy reviewed and updated to reflect most current clinical evidence per TAWG  Bone-anchored hearing aids now require prior authorization for PPO. Policy reviewed and 08/20/15 updated to reflect most current clinical evidence per TAWG 08/26/16  Policy reviewed and updated to reflect most current clinical evidence per TAWG 12/16/2020  Medical policy placed on the new Paramount Medical Policy Format

PG0218 – 08/09/2021  Changed medical policy title from Bone-Anchored Hearing Aid (BAHA) to Implantable Bone 08/09/2021 Conduction and Bone-Anchored Hearing Aids  Policy reviewed and updated to reflect most current clinical evidence

REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services

Ohio Department of Medicaid

American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services

Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets

U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/ Industry Standard Review

Hayes, Inc.

Industry Standard Review

PG0218 – 08/09/2021