Medical Policy: 01.01.27
Original Effective Date: April 2015
Reviewed: August 2020
Revised: August 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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.
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).
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:
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):
Other implantable bone-conduction hearing systems that rely on an abutment and have similar indications as the Cochlear Americas’ Baha 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.
Three partially implantable magnetic bone conduction devices that have received 510(k) clearance from the FDA are:
The Bonebridge™ (MED-EL, Innsbruck, Austria) is another partially implantable bone-conduction implant that is considered an active transcutaneous device.
Recently, an adhesive bone conduction hearing system (Adhear) has been developed for conductive hearing loss or single-sided deafness (SSD). The ADHEAR System consists of the ADHEAR Audio Processor and the ADHEAR Adhesive Adapter. The non-implantable status of this device means it would be classified as a hearing aid.
(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.
Contra Lateral Routing of Signal (CROS) is a hearing aid technology for people with unilateral hearing. The technology allows two implementations: CROS and BiCROS.
Using this technology, a hearing aid-like device on the user's deaf side uses its microphone to pick up sound from that side and sends it to another instrument at the better ear. The sound is then inserted into the good ear.
The CROS implementation is for a user who has relatively normal hearing in the good side and has hearing that can't be aided on the bad side. The receiving BTE device on the bad side transmits the sound to a device on the good side. The user hears the amplified sound from the bad side in their good ear. The users hears the sound from the good side naturally in their good ear, without amplification.
The BiCROS implementation is for a user with little or no hearing on one side and with some hearing loss in their better ear. It works just like the CROS implemenation, except that the device on the good side is actually a fully capable hearing aid for hearing sounds from the good side that is also capable of receiving the sound transmitted from the CROS aid on the other side.
Recent studies comparing CROS/BiCrOS and BAHA found that sound localization was not improved in the soft-band BAHA and was significantly impaired with the CROS/BiCROS. Both devices significantly improved speech-in noise perception when targeted to the impaired ear side. There were no significant differences reported for preference between devices or subjective assessments of background noise or sound quality.
Background Treatment begins with the selection of an appropriate device. In the unique case of severe-to-profound USNHL, patients attempt to resolve the loss of the primary advantages of binaural hearing, including localization, release from the head shadow effect, binaural squelch, and binaural summation. Due to the presence of severe-to-profound hearing loss, very poor word recognition, and possibly hyperacusis in the poorer ear, these patients are typically unable to benefit from a conventional hearing device. Research has demonstrated that these patients may benefit from a variety of hearing devices that may improve their auditory experience primarily by eliminating the head shadow effect. These device options utilize different modalities of hearing including AC (e.g., CROS/BICROS), transcranial BC (e.g., transcranial CROS, TransEar®, SoundBite™, AOIS), and electric stimulation (e.g., cochlear implant (CI)). Localization, partial restoration of binaural squelch and binaural summation, and reduction of tinnitus may be addressed with a CI. Typically, some of these abilities may not be restored with pseudo-binaural device options,2 and the CI is currently at the clinical trial stage and is not FDA approved for the management of severe-to-profound USNHL.
*The CI now has FDA approval for single sided deafness.
Hearing Aids: Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment. Most hearing aids share several similar electronic components, and technology used for amplification may be analog or digital. (Semi-implantable electromagnetic hearing aids and bone-anchored hearing aids are classified by the U.S. Food and Drug Administration (FDA) as hearing aids. Some non-wearable hearing devices are described as hearing devices or hearing systems. Because their function is to bring sound more effectively into the ear of a person with hearing loss, for the purposes of this policy, they are hearing aids).
The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.
The BAHA hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
The Food and Drug Administration (FDA) 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 Bonebridge™ (MED-EL, Innsbruck, Austria) is another partially implantable bone-conduction implant system that is considered an active transcutaneous device and recently received FDA approval. In 2019 the Bonebridge was granted 510(k) clearance by the FDA as substantially equivalent to other predicate devices for:
When used in a non-implantable manner (e.g. Softband) the BAHA system is categorized as a hearing aid.
Prior approval required
The use in children younger than 5 years of age is considered investigational, this indication lacks FDA approval at this time.
All members must meet one of the following medical reasons for implantation, without a medical reason other devices can be used, the use of BAHA is considered not medically necessary:
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):
For members without one of the medical reasons noted above, it is considered not a medical necessity for an implantable device.
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:
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 pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB3 HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55dcb HL for use with the BPI1O Power sound processor, and 65 db HL for use with the Cordelle 11 Sound Processor.
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.
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:
With improvement in technology for both the CROS/BiCROS devices the non-surgical CROS/BiCROS devices should be considered prior to surgical implantation of the bone anchored devices. The medical inability, and not preference alone, to wear a CROS device (as noted under medical criteria) are the only scenarios where bone-conduction/bone-anchored hearing aids may be considered medically necessary.
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.
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, Bonebridge), 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.
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.
Replacement parts or upgrades to existing bone-anchored hearing aid components are considered medically necessary when ALL of the following are met:
Changing out abutments is only necessary in the case of abutment failure/loosening or infection, and should not be for upgrade to a more convenient model.
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 FDA approval of bone-anchored hearing aids was based on the equivalencies to the CROS device and studies have yet to show superiority of the implantable device. The surgery involved in BAHA placement makes the implantation not a first line treatment for hearing loss if possible.
Streamers for the processor to connect to wireless devices (i.e Oticon Medical Streamer) is considered a convenience item and not a covered benefit.
It would be the expectation that documentation is available to support the medical criteria and the hearing loss criteria within the medical policy.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.