Medical Policy: 01.01.27 

Original Effective Date: April 2015 

Reviewed: March 2018 

Revised: March 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Hearing loss (deafness, hearing impairment) refers to the partial or complete inability to hear sounds in one or both ears. 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 detection thresholds as mild (20-40 dB), moderate (40-60 dB), severe (60-80 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.

 

Conductive hearing loss is the poor transmission of sound waves through the external ear canal to the bones (ossicles) of the middle ear. It may be caused by obstruction (impacted earwax, or cerumen), accumulation of fluid in the middle ear (middle ear effusion), or disturbances affecting the continuity of the ossicles of the middle ear (otosclerosis). Temporary conductive hearing loss usually results from impacted earwax and acute middle ear infection (acute otitis media) with effusion. Persistent conductive loss may be caused by chronic otitis media, trauma, or otosclerosis.

 

Sensorineural hearing loss (sensory organ or nerve-related hearing loss) is the poor transmission of sound waves as a result of damage to the essential organ of hearing (cochlea) within the inner ear and/or damage to the eighth cranial nerve (vestibulocochlear nerve). Sensorineural hearing loss can be caused by drugs that harm some part of the hearing mechanism (ototoxic drugs), endolymphatic hydrops (Ménière's syndrome), brain tumors, and head trauma. Sensorineural hearing loss can also result from problems affecting the eighth cranial nerve (vestibulocochlear nerve) such as acoustic neuroma; systemic diseases like multiple sclerosis, diabetes, Paget's disease, and cerebrovascular disease; and immunosuppressive diseases. Because the balance centers within the inner ear are associated with the vestibulocochlear nerve, sensorineural hearing loss may be associated with vertigo and balance disorders.

 

In addition, sensorineural hearing loss may be caused by noise trauma or by the aging process. Noise-induced hearing loss results from extended overexposure to hazardous noise that permanently damages the cochlear hair cells. The most common types of noise that can produce a high-frequency hearing loss include industrial noise, gunshots, and loud music. Aging can also result in progressive age-related hearing loss (presbycusis), which occurs as degenerative changes manifest within the cochlea.

 

Mixed hearing loss refers to a combination of conductive and sensorineural hearing loss. In individuals with mixed hearing loss, it is important to note that although the conductive portion of the hearing loss may be helped by medical or surgical treatment, the sensorineural hearing loss is permanent.

 

Hearing loss is described as conductive, sensorineural, or mixed, and can be unilateral or bilateral. Normal hearing is the detection of 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 (PTA) detection thresholds as mild (20-40 dB), moderate (40-60 dB), severe (60-80 dB), and profound (≥80 dB).

 

Implantable Bone Conducted Hearing Aids (BAHA)

These devices are referred to as Hearing Aid, Bone Conduction in FDA approval. FDA review also indicates that this device has substantially equivalent technology as air-conduction hearing aids with digital sound processing. The Food and Drug Administration (FDA) has cleared for marketing the bone anchored hearing aid for individuals aged 5 years and older who have conductive or mixed hearing loss and for patients with sensorineural deafness in one ear and normal hearing in the other based on a 510(k) application. Such clearance was granted based on a determination that the BAHA was substantially equivalent to a contralateral routing of sound (CROS) air conduction hearing aid.

 

The indications for the BAHA System have broadened since the initial FDA approval. In 2001, the BAHA system was approved for bilateral implantation. For bilateral implantation of bone-anchored hearing aids, patients must have moderate to severe bilateral symmetrical conductive hearing loss (defined as less than 10 dB difference in average or less than 15 dB in bone-conduction thresholds at 500, 1000, 2000, and 4000 Hz) or mixed hearing loss with average bone conduction thresholds better than 45 dB hearing loss.

 

In 2002, the BAHA system was approved for single sided deafness (SSD) or unilateral sensorineural hearing loss. According to the FDA, the use of BAHA hearing aid for SSD is intended to improve speech recognition. The SSD indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing.

 

FDA cleared the BAHA system 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 1 ear and normal hearing in the other (ie, single-sided deafness, SSD);
  • 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. This condition would be considered not a medical benefit due to the use being for convenience.

 

There are 5 BAHA® sound processors for use with the BAHA auditory osseointegrated implant system manufactured by Cochlear Americas (Englewood, CO) that have received 510(k) clearance from the U.S. Food and Drug Administration (FDA):

  • BAHA Cordelle II
  • BAHA Divino
  • BAHA Intenso (digital signal processing)
  • BAHA BP100
  • BAHA 5 (upgraded from the BP100 and BAHA 4)

 

Other implantable bone-conduction hearing systems that rely on an abutment and have similar indications as the Cochlear Americas’ Baha devices:

  • OBC Bone Anchored Hearing Aid System (Oticon Medical, Askim, Sweden). Cleared in 2008.
  • Ponto Bone Anchored Hearing System (Oticon Medical). Cleared in September 2012. A next-generation Ponto Pro device can be used with either Oticon or Baha implants.

 

Partially Implanted/Non-fully Implanted Hearing Devices

Partially implantable magnetic bone-conduction hearing systems are available as an alternative to the bone-conduction hearing systems connected percutaneously via an abutment. With this technique, acoustic transmission occurs via magnetic coupling of the external sound processor and 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. Since the processor adheres magnetically to the implant, there is no need for a percutaneous abutment to physically connect the external and internal components.

 

Two partially implantable magnetic bone conduction devices that have received 510(k) clearance from the FDA are:

  • Otomag Bone Conduction Hearing System and
  • Cochlear BAHA Attract

 

Pure Tone Audiometry (PTA)

(PTA) is the key hearing measurement used to identify hearing threshold levels of an individual, enabling determination of the degree, type and configuration of a hearing loss. Thus, providing the basis for diagnosis and management.

 

A convenient summary of the audiogram for each ear is the pure-tone average (PTA) of thresholds measured at specific frequencies.

 

The most common PTA definition found in epidemiological, or population-based, studies is the four-frequency average of 500, 1000, 2000, and 4000 Hz.

 

As the PTA increases, the hearing ability decreases. Normal hearing for speech is observed in adults with PTAs of 25 dB HL (hearing loss) or less. At a PTA of around 40 dB HL in both ears, most people are considered functionally impaired and could benefit from amplification. Severe to profound losses are present when PTAs are greater than 70 dB HL.

 

Prior Approval:

Prior approval required

 

Policy:

The use in children younger than 5 years of age is considered investigational, this indication lacks FDA approval at this time.

 

Medical Criteria

All members must meet one of the following medical reasons for implantation:

For implantable Bone-Anchored Hearing Aids (BAHA) to be considered a contract benefit there must be a medical reason that air conducted hearing aids and/or contralateral routing of signal (CROS/BiCROS) devices cannot be used. This includes the following conditions (must meet at least one medical condition below 1-5):

  1. Congenital or surgically induced ear malformations of the external or middle ear canal (for example, atresia) or
  2. Otosclerosis in patients who cannot undergo stapedectomy: or
  3. Severe chronic external otitis, making use of air conducted aids impossible; or
  4. Chronic otitis media with draining that makes the use of air conducted aids impossible; or
  5. Tumors of the external ear canal or tympanic cavity

 

For members without one of the medical reasons noted above, it is considered not a medical necessity for an implantable device.

 

Audiologic Criteria

Unilateral or bilateral fully implantable bone-conduction/bone-anchored hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in patients 5 years of age and older with moderate to severe conductive or mixed hearing loss and meet the following audiologic criteria:

 

Single-Sided or Bilateral: Conductive Hearling Loss or Mixed Hearing Loss along with one of the medical criteria points above, the following level of hearing loss must be documented:

  • A pure-tone average (PTA) bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz is mild to moderate (35-65 dB HL)
  • The use of bone-anchored hearing implants are considered investigational for severe hearing loss. The most powerful processors can compensate for, and have been proven to be beneficial in hearing loss only up to 65 dB HL.

 

Single-Sided Sensorineural Hearing Loss

A unilateral, fully 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 (CROS) or BiCROS in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear who meet one of the medical criteria points above and the following audiologic criteria:

  • The pure-tone average air-conduction threshold of the normal ear should be no greater than 20 dB measured at 0.5, 1, 2, and 3 kHz.

 

Bilateral Sensorineural Hearing Loss

Given the lack of both high-quality evidence and U.S. Food and Drug Administration (FDA) approval, including those with bilateral sensorineural hearing loss, is considered investigational.

 

Semi-Implantable Devices and Middle Ear Devices

The available evidence for semi-implantable magnetic bone-conduction hearing systems (e.g., The OtomagAlpha™ System) as well as middle ear hearing aids (e.g., The Esteem® Implantable Hearing System, Maxum, Soundbridge), are preliminary and limited to small case series. Therefore, conclusions on net health outcomes cannot be made. There is a necessity for larger studies that follow the subjects for the long term. Therefore, semi-implantable bone-conduction hearing systems and middle ear devices are considered investigational.

 

Transcutaneous Worn-Bone Anchored Device

A device utilizing a headband, Softband or intraoral (e.g., Soundbite) device are considered hearing aids (not implantable) and can be used in any age group.

  1. May be considered medically necessary if the contract has a hearing aid benefit,AND
  2. The medical criteria is met (must meet at least one medical condition below):
    • Congenital or surgically induced ear malformations of the external or middle ear canal (for example, atresia); or
    • Otosclerosis in patients who cannot undergo stapedectomy or have had failed stapedectomy or
    • Severe chronic external otitis, making use of air conducted aids impossible or
    • Chronic otitis media with draining that makes the use of air conducted aids impossible or
    • Tumors of the external ear canal or tympanic cavity, AND
  3. The audiologic criteria is met based on the type of hearing loss

 

Replacement

Replacement parts or upgrades to existing bone-anchored hearing aid components are considered medically necessary when ALL of the following are met:

  • Currently used component is no longer functional and cannot be repaired. (If an existing implant is functioning, an upgrade or replacement of electrodes to another processor will not be approved.) AND
  • There is no evidence to suggest that the device has been lost, abused or neglected. AND
  • The replacement must not be solely for better technology or improved aesthetics AND
  • It has been a minimum of five years from original placement. The processor must be non-functional. Age alone does not meet necessity for processor replacement. AND
  • The original processor was being used on a daily basis until malfunction

 

Rationale

At this time, the availability of well-designed random controlled trials comparing the benefit of air-conducted aids including CROS aids and BAHA prosthetics do not show a benefit of one device over the other outside of convenience and aesthetics. The surgery involved in BAHA placement makes the implantation not a first line treatment for hearing loss if possible.

 

It would be the expectation that documentation is available to support the medical criteria and the hearing loss criteria within the medical policy.

 

Streamers for the processor to connect to wireless devices (i.e Oticon Medical Streamer) is considered a convenience item and not a covered benefit.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • S2230 Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear
  • V5095 Semi-implantable middle ear hearing prosthesis
  • 69710 Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
  • 69711 Removal or repair of electromagnetic bone conduction hearing device in temporal bone
  • 69799 Unlisted procedure, middle ear
  • 69714 Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy
  • 69715 Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; with mastoidectomy
  • L8690 Auditory osseointegrated device, includes all internal and external components
  • L8691 Auditory osseointegrated device, external sound processor, excludes 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
  • L8693 Auditory osseointegrated device abutment, any length, replacement only
  • L8694 Auditory osseointegrated device, transducer/actuator, replacement only, each
  • 69717 Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy
  • 69718 Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; with mastoidectomy

 

Selected References:

  • Colquitt JL, Jones J, Harris P et al. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technol Assess 2011; 15(26):1-200, iii-iv.
  • McLarnon CM, Davison T, Johnson IJ. Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope 2004; 114(5):942-4.
  • Janssen RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing loss: a systematic review. Otolaryngol Head Neck Surg 2012; 147(3):412-22.
  • Pai I, Kelleher C, Nunn T et al. Outcome of bone-anchored hearing aids for single-sided deafness: a prospective study. Acta Otolaryngol 2012; 132(7):751-5.
  • Zeitler DM, Snapp HA, Telischi FF et al. Bone-anchored implantation for single-sided deafness in patients with less than profound hearing loss. Otolaryngol Head Neck Surg 2012; 147(1):105-11.
  • Dun CA, Faber HT, de Wolf MJ et al. Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. Otol Neurotol 2012; 33(2):192-8.
  • Hol MK, Nelissen RC, Agterberg MJ et al. Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol 2013; 34(6):1071-5.
  • Centers for Medicare and Medicaid Services. Medicare Policy Benefit Manual. Chapter 16 - General Exclusions from Coverage
  • Esteem Implantable Hearing System. FDA Summary of Safety and Effectiveness
  • Gunduz B, Atas A, Bayazit YA et al. Functional outcomes of Vibrant Soundbridge applied on the middle ear windows in comparison with conventional hearing aids. Acta Otolaryngol 2012; 132(12):1306-10.
  • Monini S, Biagini M, Atturo F et al. Esteem((R)) middle ear device versus conventional hearing aids for rehabilitation of bilateral sensorineural hearing loss. Eur Arch Otorhinolaryngol 2012.
  • Zwartenkot JW, Hashemi J, Cremers CW, et al. Active middle ear implantation for patients with sensorineural hearing loss and external otitis: long-term outcome in patient satisfaction. Otol Neurotol. 2013;34(5):855-61.
  • Peters JP, Smit AL, Stegeman I, et al. Review: Bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. Aug 14 2014. PMID 25124297
  • Pai I, Kelleher C, Nunn T et al. Outcome of bone-anchored hearing aids for single-sided deafness: a prospective study. Acta Otolaryngol 2012; 132(7):751-755. PMID 22497318
  • Zeitler DM, Snapp HA, Telischi FF et al. Bone-anchored implantation for single-sided deafness in patients with less than profound hearing loss. Otolaryngol Head Neck Surg 2012; 147(1):105-111. PMID 22368043
  • Crukley, J. & Goyette, A. (2016). Basic and advanced considerations in CROS and BiCROS fitting: streaming control and counseling. Innovations, 6 (1).
  • Wiliams, V. A., McArdle, R. A., & Chisolm, T.H. (2012). Subjective and objective outcomes from new BiCROS technology in a veteran sample. Journal of the American Academy of Audiology, 23(10), 789-806.
  • Peters JP, Smit AL, Stegeman I, et al. Review: Bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. Jan 2015;125(1):218-226. PMID 25124297
  • Hol MK, Bosman AJ, Snik AF, Mylanus EA, Cremers CW. Bone-anchored hearing aids in unilateral inner ear deafness: an evaluation of audiometric and patient outcome measurements. Otol Neurotol. 2005;26(5):999–1006.
  • Ernst A, Todt I, Wagner J. Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: A systematic review. Laryngoscope. 2016;126(6):1451-7.

 

Policy History:

  • March 2018 - Interim Review, Policy Revised
  • December 2017 - Interim Review, Policy Revised
  • August 2017 - Annual Review, Policy Revised
  • June 2017 - Interim Review, Policy Revised
  • November 2016 - Interim Review, Policy Revised
  • August 2016 - Policy revised
  • February 2016 - Annual Review, Policy Revised
  • April 2015 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.