![]() | Medical Policy |
| Subject: | Bone-Anchored Hearing Aids | ||
| Policy #: | SURG.00020 | Current Effective Date: | 01/13/2010 |
| Status: | Revised | Last Review Date: | 11/19/2009 |
| Description/Scope |
Conventional external hearing aids can be categorized as air conduction (AC) hearing aids or bone conduction (BC) hearing aids. An implantable bone conduction hearing aid, also called a bone-anchored hearing aid (BAHA®) (Cochlear Americas, Centennial, CO and Cochlear Limited Bone Anchored Solutions AB, Mölnlycke, Sweden), functions by using a skin penetrating titanium implant that transmits sound waves to the cochlea through the skull bone.
This document addresses the use of the BAHA®, a U.S. Food and Drug Administration (FDA) approved implantable bone conduction hearing aid as an alternative to an air conduction hearing aid in the treatment of moderate-to-severe hearing loss (HL), or, to improve speech recognition in individuals with unilateral sensorineural hearing loss, also referred to as single sided deafness (SSD™).
Note: Please see the following documents related to implants and hearing aids for the treatment of hearing loss:
| Position Statement |
Medically Necessary:
An implantable bone-anchored hearing aid is considered medically necessary for individuals meeting either of the two criteria sets A or B.
Investigational and Not Medically Necessary:
An implantable bone-anchored hearing aid is considered investigational and not medically necessary for all other indications when the above criteria are not met, including, but not limited to use in children less than five years of age.
| Rationale |
BAHA for Moderate to Severe Conductive or Mixed Hearing Loss
The medical literature contains numerous prospective and retrospective clinical trials that evaluate the safety and efficacy of an implanted bone-anchored hearing aid for moderate to severe conductive or mixed hearing loss. Patients in these studies usually received unilateral hearing aids. The early studies of the BAHA (Granstrom, 1997 and 2001; Hakansson, 1990 and 1994) were reported by the BAHA implant programs at the Sahlgrenska Hospital at the University of Göteborg, Sweden (where the BAHA was originally developed); the Nijmegen University Hospital, The Netherlands (Snik, 1995 and 2001; Stenfelt, 2000; van der Pouw, 1998 and 1999); and the Birmingham Osseointegration Program (The Queen Elizabeth, Selly Oak, and Birmingham Children's Hospitals, Birmingham, UK) (Dutt, 2002 (multiple studies); McDermott, 2002, two studies; McLarnon, 2004). Results from each of the centers are reported in multiple articles with overlapping patient populations. The authors suggest that the BAHA can provide significant improvements in functional gain, speech perception, and hearing ability in various listening situations. Patient satisfaction was also reported in self-assessed outcomes measurements including satisfaction with fit and comfort and with the quality and clarity of the sound. Follow-up in these studies varied widely, ranging from a few weeks or months to more than 20 years.
Most of the early studies from Canada and the United States describing the use of the BAHA were small, retrospective trials where investigators reported positive audiologic outcomes, few complications and high levels of patient satisfaction in those who could not tolerate or were not suitable candidates for conventional air conduction hearing aids (Wazen, 1998; Lustig, 2001; Niparko, 2003). Several authors have reported improved patient outcomes and functioning with the use of the BAHA. The BAHA is also associated with improvements in language development in children five years of age and older. In a retrospective, treatment outcome study, Lloyd and colleagues (2007) reported that children (n=85 ears, mean age at primary implantation 8.7 years) had "significant additional benefits in terms of speech recognition, sound quality, ease of use, and overall quality of life," despite experiencing adverse outcomes (e.g. trauma and failure of osseointegration were the most common reasons for failure) when implanted with the BAHA.
Indications for Bilateral BAHA for Conductive Hearing Loss
The implantation of bilateral BAHA has been evaluated in several small studies. Dutt and colleagues (2002) reported patient satisfaction and speech intelligibility in 15 patients with unilateral BAHA subsequently fitted with a bilateral BAHA. The benefits of bilateral amplification were compared to unilateral amplification in 11 of these patients who used their second BAHA for 12 months or longer. Following a subjective analysis in the form of comprehensive questionnaires, objective testing was undertaken to assess specific issues such as 'speech recognition in quiet,' 'speech recognition in noise' and a modified 'speech-in-simulated-party-noise' (Plomp) test. 'Speech in quiet' testing revealed a 100% score with both unilateral and bilateral BAHA. With 'speech in noise,' all 11 patients were reported as scoring "marginally better" with bilateral aids compared to best unilateral responses. A prospective study of 12 patients reported by Priwin and colleagues (2004) demonstrated a significant improvement in sound localization with bilateral BAHA fitting. Furthermore, the authors reported an improvement in speech reception threshold in both quiet and in noise, concluding that the outcomes with bilateral BAHA were better than with unilaterally fitted BAHA. Bosman and colleagues (2001) evaluated bilateral fittings of the BAHA in 25 patients with at least three months experience with using two BAHA. The authors reported a significant improvement in directional hearing and speech reception threshold for sentences in quiet (p<0.01) for the bilateral fittings compared to the unilateral fittings. Speech recognition in noise was also reported as significantly improved with a second BAHA.
Priwin and colleagues (2007) investigated whether fitting of bilateral BAHA in children with conductive bilateral hearing loss (BHL) provided additional hearing benefits. In this prospective case series, 22 children (15 controls) were studied with either conductive unaided or with unilateral hearing aid (UHL) or conductive BHL (with unilateral or bilateral BAHA). Baseline audiometry, tone thresholds in a sound field, speech recognition in noise and sound localization were tested with and without unilateral and bilateral hearing aids. The authors reported an additional BAHA in the children with BHL resulted in a tendency to have improved hearing in terms of better sound localization and speech recognition in noise.
The BAHA has been reported as successfully used in children younger than five years of age in Europe and the United Kingdom. However, the most recent update of the FDA notification (1999) lists age less than 5 years as a contraindication to use of the BAHA. A number of reports describe experience with preschool children or children with developmental issues that might interfere with maintenance of the implant and skin integrity. A two-stage procedure is used in young children with the fixture placed into the bone at the first stage and, after three to six months to allow for osseointegration, a second procedure to connect the abutment through the skin to the fixture. Davids and colleagues (2007) provided the BAHA to children less than five years of age for auditory and speech-language development, retrospectively comparing surgical outcomes for a group of children five years or younger (n=20) and a control group of older children (n=20). Children with cortical bone thickness greater than four millimeters underwent a single-stage procedure. The interstage interval for children having two-stage procedures was significantly longer in the study group to allow implantation in younger patients without increasing surgical or postoperative morbidity. Two traumatic fractures occurred in the study group versus four in the older children. Three younger children required skin site revision. All children were wearing their BAHA at the time of writing. McDermott and colleagues (2008) reported on the role of the BAHA in 15 children (ages two to 15 years) with Down syndrome in a retrospective case analysis and postal survey of complication rates and quality of life outcomes. All of the children were using their BAHA after follow-up of 14 months. No fixtures were lost; skin problems were encountered in three children. All 15 children were reported as having improved social and physical functioning as a result of improved hearing.
BAHA for Unilateral Sensorineural Hearing Loss
Baguley and colleagues (2006) reviewed the evidence for use of a contralateral BAHA in adults with acquired unilateral sensorineural hearing loss. None of the four controlled trials in this meta-analysis reported a significant improvement in auditory localization with the BAHA (Bosman, 2003; Niparko, 2003; Wazen, 2003; Hol, 2004). However, speech discrimination in noise and subjective measures improved with these aids; for these parameters, use of the BAHA resulted in greater improvement than that obtained with the contralateral routing of signal (CROS) systems. The authors noted a number of shortfalls in these studies including bias in terms of patient selection (two studies), all four studies were underpowered, and double reporting of patient outcomes. Lin and colleagues (2006) reported on use of the BAHA in 23 patients with unilateral deafness, and noted that speech recognition in noise was significantly better with the BAHA than with the air-conduction CROS. While the report also comments that benefit was seen in those with moderate sensorineural hearing loss in the contralateral ear (25–50 dB), this conclusion was based on only five patients. Larger studies are needed before the BAHA can be considered for use in individuals with bilateral sensorineural hearing loss.
To summarize, despite a paucity of evidence in the medical literature in the form of randomized controlled trials, the evidence reported in prospective and retrospective case series suggest the majority of individuals prefer the BAHA over conventional hearing aids and report improved outcomes in sound quality and speech recognition scores.
| Background/Overview |
Hearing loss can be classified as conductive, sensorineural, or mixed hearing loss. Conductive hearing loss involves the external and middle ear and is due to mechanical or physical blockage of sound as a result of excessive cerumen, a punctured eardrum, birth defects, ear infections or heredity. In sensorineural or "nerve" hearing loss, the auditory cranial nerve or part of the bone of the inner ear is damaged due to birth-related injury (atresia), long-term viral or bacterial infections, trauma, exposure to loud noises, the use of certain drugs, fluid buildup in the middle ear, or a benign tumor in the inner ear (acoustic neuroma). Mixed hearing loss is conductive hearing loss coupled with sensorineural hearing loss. Normal range or no impairment of hearing occurs at 0 to 20 dB threshold. The American Speech-Language-Hearing Association (ASLHA, 2007) defines the degree (severity) of hearing loss (HL) as mild (20 to 40 dB), moderate (40 to 60 dB), severe (60 to 80 dB), and profound (≥ 80 dB).
Conventional external hearing aids can be generally categorized as air conduction hearing aids or bone conduction hearing aids. Air conduction hearing aids are designed for placement in several locations including fitted behind the ear or on the body (both require the use of an ear mold), in the outer ear, ear canal or almost entirely in the canal, or as a contralateral routing of signal (CROS) hearing aid (i.e. a microphone is located on the impaired hearing side and transmits a signal wirelessly over a radio frequency to the normal hearing ear via an ear mold). Use of ear molds may be problematic in individuals 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 individuals, 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 aids 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 eyeglasses. These hearing aids may be associated with either pressure headaches or soreness.
The BAHA system utilizes an FDA-approved, bone-anchored, bone conduction hearing aid, specifically indicated for individuals five years of age and older. The indications for the BAHA have expanded since the initial approval. The BAHA is currently used for individuals with unilateral or bilateral conductive or mixed (conductive and sensorineural) hearing loss, and for unilateral sensorineural hearing loss. The BAHA processor is coupled to a titanium fixture (screw) protruding through the skin located in the upper mastoid region on the temporal bone where it has fused with the bone in a process called "osseointegration." The BAHA system bypasses the middle ear altogether, sending sound around the area, naturally stimulating the cochlea through bone conduction. The difference between the standard bone conduction hearing aid and the bone-anchored hearing aid is direct stimulation of the bone instead of stimulation through the skin. The BAHA Divino, BAHA Intenso, BAHA Cordelle II, and BAHA BP100 (a substantially equivalent processor to predicate models) are the available FDA-approved sound processor models. The BAHA Divino and BP100 may be utilized by individuals with a pure tone average bone conduction threshold of 45 dB or better (FDA, 2004; FDA, 2009), the BAHA Intenso for individuals with pure tone average bone conduction threshold of 55 dB or better (FDA, 2008), while the Cordelle II is indicated for more severe hearing loss, with a pure tone average bone threshold of 65 dB or better (FDA, 2008).
Implantable or bone-anchored conduction hearing aids are recommended for individuals who are unable to use conventional air conduction hearing aids or have undergone ossicular replacement surgery because of chronic otitis media, congenital malformation of the middle/external ear or other acquired malfunctions of the middle or external ear canals which preclude wearing of a conventional air conduction hearing aid. Consideration should be given to the individual's psychological, physical, emotional and developmental capabilities of maintaining hygiene as the skin is adjacent to the implant abutment. For children and individuals with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation.
| Definitions |
Aural atresia: lack of development of the ear canal
Conductive hearing loss: occurs when sound is conducted inefficiently through the outer ear canal to the eardrum and the small bones (ossicles) of the middle ear; involves a reduction in sound level or the ability to hear faint sounds
DB: decibel, unit for expressing the loudness of sound
HL: hearing loss
Hz: Hertz, unit of frequency equivalent to 1 cycle per second
Mixed hearing loss: conductive hearing loss in combination with a sensorineural hearing loss; damage exists in the outer or middle ear and also in the inner ear (cochlea) or auditory nerve, in one or both ears
Otitis: inflammation of infection of the ear
Pure tone average (PTA): the average of hearing sensitivity at 0.5, 1, 2, and 3 kHz
Sensorineural hearing loss: a permanent hearing loss related to the sensory or neural structures responsible for hearing that involves a reduction in sound level or ability to hear faint sounds; affects speech understanding or the ability to hear clearly; the involved structures include, but are not limited to, the cochlea and the acoustic nerve
Single sided deafness (SSD™): significant or total hearing loss in one ear; also known as, unilateral sensorineural hearing loss; one cause of single sided deafness is surgery to treat acoustic neuroma or other tumors of the eighth cranial nerve
Temporal bone: part of the skull, on the side of the head
Tympanic membrane: eardrum
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
| CPT | |
| 69710 | Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone |
| 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 |
| 69717 | Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment of external speech processor cochlear stimulator; without mastoidectomy |
| 69718 | Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment of external speech processor cochlear stimulator; with mastoidectomy |
| HCPCS | |
| L8690 | Auditory osseointegrated device, includes all internal and external components |
| L8691 | Auditory osseointegrated device, external sound processor, replacement |
| ICD-9 Procedure | |
| 20.95 | Implantation of electromagnetic hearing device |
| ICD-9 Diagnosis | |
| 380.10 | Infective otitis externa, unspecified |
| 380.15-380.16 | Chronic mycotic, other chronic infective otitis externa |
| 380.21-380.23 | Other otitis externa |
| 380.50-380.53 | Acquired stenosis of external ear canal |
| 381.10-381.4 | Chronic serous, mucoid other otitis media |
| 382.1-382.9 | Chronic suppurative otitis media |
| 384.20-384.25 | Perforation of tympanic membrane |
| 385.00-385.9 | Other disorders of middle ear and mastoid |
| 389.00-389.9 | Hearing loss |
| 744.00-744.09 | Anomalies of ear causing impairment of hearing |
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
BAHA
BAHA BP100
BAHA Cordelle II
BAHA Divino
BAHA Intenso
Bone-Anchored Hearing Aid
Bone Conduction Hearing Aid
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
| Document History |
| Status | Date | Action |
| Revised | 11/19/2009 | Medical Policy & Technology Assessment Committee (MPTAC) review. Added FDA 510(k) substantially equivalent sound processor, the BAHA BP100, to the Medically Necessary Audiologic criteria specific to bilateral and unilateral bone-anchored hearng aids. Updated Rationale, Background, Index, and References. Added Web Sites for Additional Information. |
| Revised | 11/20/2008 | MPTAC review. Revised Position Statements to include the FDA-approved BAHA Intenso™. Clarified Audiologic criteria for bilateral implants. Updated Description, Background, Index, and References updated |
| Revised | 08/28/2008 | MPTAC review. Revised document title to Bone-Anchored Hearing Aids. Revised Medically Necessary Audiologic criteria to include separate bilateral or unilateral implant indications based on updated FDA-approval criteria for the BAHA. Clarified Medically Necessary statement for unilateral sensorineural hearing loss. Updated Description, Rationale, Definitions, Index and References. |
| 02/21/2008 | The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. | |
| Reviewed | 08/23/2007 | MPTAC review. Position Statement clarified. Rationale, Background, Definitions, and References updated. |
| 01/01/2007 | Updated Coding section with 01/01/2007 CPT/HCPCS changes. | |
| Revised | 09/14/2006 | MPTAC review. Revision based on FDA and Hayes additional criteria for the BAHA System. References and Coding updated. |
| Reviewed | 07/25/2006 | MPTAC review. |
| Revised | 07/14/2005 | MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
| Pre-Merger Organizations | Last Review Date | Document Number | Title |
| Anthem, Inc. | 04/28/2005 | SURG.00020 | Bone-Anchored, Bone Conduction Hearing Device, Implantable |
| WellPoint Health Networks, Inc. | 09/23/2004 | 2.03.13 | Implantable Bone Conduction Hearing Aids |