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Conventional external hearing aids can be generally subdivided into air conduction (AC) hearing aids and bone-conduction hearing aids. Air conduction hearing aids require the use of ear molds, which may be problematic in 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 function by transmitting sound waves through the bone to the ossicles of the middle ear. Implantable, bone-anchored hearing aids (BAHA) and a partially implantable system have been investigated as alternatives to conventional bone-conduction hearing aids for patients with conductive or mixed hearing loss or in patients with unilateral single-sided sensorineural hearing loss.
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 dB (decibel). 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). PTA is calculated by averaging the hearing sensitivities (ie, the minimum volume that the patient hears) at multiple frequencies (perceived as pitch), typically within the range of 0.25 to 8 kHz.
Sound amplification through the use of an 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.
External bone-conduction hearing aids function by transmitting sound waves through the bone to the ossicles of the middle ear. The external devices must be closely applied to the temporal bone, with either a steel spring over the top of the head or with the use of a spring-loaded arm on a pair of spectacles. These devices may be associated with either pressure headaches or soreness.
The bone-anchored hearing aid (BAHA) implant system works by combining a vibrational transducer coupled directly to the skull via a percutaneous abutment that permanently protrudes through the skin from small titanium implant anchored in the temporal bone. The system is based on the process of osseointegration though which living tissue integrates with titanium in the implant over a period of 3 to 6 months, allowing amplified and processed sound to be conducted 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, or as an alternative to an AC hearing aid with CROS for individuals with unilateral sensorineural hearing loss.
Partially implantable magnetic bone-conduction hearing systems are available as an alternative to bone-conduction hearing systems connected 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.
There are five 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 FDA:
The U.S. Food and Drug Administration (FDA) approved the BAHA system for the following indications:
The BAHA implant is cleared for use in children aged 5 years and older, and in adults.
BAHA sound processors can also be used with the BAHA® Softband™. With this application, there is no implantation surgery. The sound processor is attached to the head using either a hard or soft headband. The amplified sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The BAHA® Softband™ received FDA clearance in 2002 for use in children under the age of 5. As this application has no implanted components, it is not addressed in the policy.
In November 2008, the device “OBC Bone Anchored Hearing Aid System” (Oticon Medical, Kongebakken, Denmark) was cleared by FDA for marketing through the 510(k) process. Subsequently, additional bone-conduction hearing systems have received 510(k) marketing clearance from FDA including Otomag® (Sophono Inc., Boulder, CO) and Ponto™ (Oticon Medical). The Ponto Pro processor can be used with the Oticon or BAHA implants. In May 2011, Sophono Inc. and Oticon Medical partnered to receive 510(k) marketing clearance from FDA for the Otomag Alpha 1(M), a partially implantable bone-conduction hearing system. All of these devices were determined to be substantially equivalent to existing devices (eg, the Xomed Audiant™, which was FDA cleared for marketing in 1986 but is no longer available). They share similar indications as the Cochlear Americas BAHA devices. The 2 partially implantable magnetic bone-conduction devices that have received 510(k) clearance from FDA are:
The BoneBridge™ (MedEl, Innsbruck, Austria) is another partially-implantable bone-conduction implant that is cleared for marketing in Europe but has not received FDA approval for use in the U.S.
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 and was cleared for marketing through FDA’s 510(k) clearance process in 2011 for similar indications as the BAHA. Because this system has no implanted components, it is not addressed in the current policy.
Note: See the Cochlear Implants policy, for the treatment of severe to profound deafness.
POLICYNOTE: 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 bilateral 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 a conductive or mixed hearing loss who also meet at least one of the following criteria:
AND meet the following audiologic criteria:
For bilateral implantation, patients should meet the above audiologic criteria, and have a 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 patients with bilateral sensorineural hearing loss, are considered investigational.
Partially implantable magnetic bone-conduction hearing systems using magnetic coupling for acoustic transmission (eg, Otomag Alpha 1 and BAHA Attract) are considered investigational.
POLICY EXCEPTIONSFederal 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.
The coverage guidelines outlined in the Medical Policy should not be used in lieu of the Member's specific benefit plan language.
In patients 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, patients (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 Nervous/Mental Conditions, 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 Medically Necessary, “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 HISTORY8/24/2007: 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 added. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.03
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.