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DESCRIPTIONConventional external hearing aids can be generally subdivided into air conduction hearing aids and bone conduction hearing aids. In patients with chronic middle ear and ear canal infections, atresia of the external canal, or an ear canal, bone-conduction hearing aids may be an alternative.
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. In these patients, bone conduction hearing aids may be an alternative.
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. Semi-implantable bone conduction hearing aids have been investigated as an alternative. The bone-anchored hearing aid (BAHA) implant system works by combining a vibrational transducer coupled directly to the skull via a 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, allowing amplified and processed sound to be conducted via the skull bone directly to the cochlear.
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.
The 2 partially implantable magnetic bone-conduction devices that have received 510(k) clearance from FDA are:
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:
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 bone conduction (bone-anchored) hearing aids, including bilateral implantation or use in patients with bilateral sensorineural hearing loss is considered investigational.
Partially implantable 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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medially necessary.
The coverage guidelines outlined in the Medical Policy should not be used in lieu of the Member's specific benefit plan language.
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.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.03
CODE REFERENCEThis 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.