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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 three 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:

• BAHA® Cordelle II™
• BAHA® Divino™
• BAHA® Intenso™ (digital signal processing)

The U.S. Food and Drug Administration (FDA) approved 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 one ear and normal hearing in the other (i.e., 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.

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.

Note: See the Cochlear Implants policy, for the treatment of severe to profound deafness.

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. 

• Dermatitis of the external canal 

AND meet the following audiologic criteria:

• 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).
• 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, 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. 

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 are considered investigational.

The coverage guidelines outlined in the Medical Policy should not be used in lieu of the Member's specific benefit plan language.

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.

Covered Codes