MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Implantable Bone Conduction and Bone-Anchored Hearing Aids

Number 7.01.547*

Effective Date March 25, 2014

Revision Date(s) 03/10/14; 03/18/13

Replaces 7.01.03

*Medicare has a policy.

Policy

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Unilateral or bilateral implantable bone conduction (bone-anchored) hearing aid(s) may be considered medically necessary when the following criteria are met.

Unilateral Conductive or Mixed Hearing Loss

Unilateral implantable bone conduction (bone-anchored) hearing aid 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 meet ONE of the following medical criteria:

  • Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear; OR
  • Chronic external otitis or otitis media; OR
  • Tumors of the external canal and/or tympanic cavity; OR
  • 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).

Bilateral Conductive or Mixed Hearing Loss

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 who 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 kHz (4 kHz for OBC and Ponto™ Pro devices), OR
  • Less than 15 dB at individual frequencies.

Single-sided Sensorineural Deafness and Normal Hearing in the Other Ear

An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to a contralateral routing of sound (CROS) air-conduction 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.

Non-implanted Bone-conduction (bone-anchored) Hearing Aid

A BAHA® sound processor worn on the skull with a BAHA® Softband™ may be considered medically necessary in children under 5 years old who meet the conductive or mixed hearing loss criteria (see above), as an alternative to an air conduction hearing aid. The non-implanted use of the BAHA sound processor may be implemented as a pre-surgical trial in children under 5 years of age. (See Benefit Application).

Other Uses

Use of implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss is considered investigational.

Partially implantable magnetic bone conduction hearing systems using magnetic coupling for acoustic transmission (e.g. Otomga®Alpha 1, BAHA® Attract) are considered investigational.

A bone-conduction (bone-anchored) hearing aid is considered investigational for all other indications when the medical and audiologic criteria in this policy are not met; whether the device is attached to an implanted abutement or worn externally with a headband or softband.

Related Policies

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1.01.528

Hearing Aids (Excludes Implantable Devices)

7.01.05

Cochlear Implant

7.01.84

Semi-Implantable and Fully Implantable Middle Ear Hearing Aids

Policy Guidelines

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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. Surgical implantation of the BAHA® device is not FDA approved for children younger than 5 years of age.

Unique clinical circumstances may justify individual consideration for use of the bone-conduction (bone-anchored) sound processor with headband or softband before 5 years of age, based on a review of applicable medical records to verify the medical necessity criteria listed in this policy are met. (See Benefit Application).

Coding

CPT

69710

Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone

69711

Removal or repair of electromagnetic bone conduction hearing 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

HCPCS

L8690

Auditory osseointegrated device, includes all internal and external components

L8691

Auditory osseointegrated device, external sound processor, replacement

L8692

Auditory osseointegrated device, external sound processor; used without osseointegration, body worn, includes headband or other means of external attachment

L8693

Auditory osseointegrated device abutment, any length, replacement only

Note: The Audiant bone conductor is a type of electromagnetic bone conduction hearing device. This product is no longer actively marketed. However, patients with existing Audian devices may require replacement, removal, or repair.

Note: Cochlear implants, used for the treatment of severe to profound deafness are addressed in a separate medical policy. (See Related Policies)

Description

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Conventional external hearing aids can be generally subdivided into air-conduction 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.

In children under 5 years of age the transcutaneous use of the BAHA®, where the bone conduction-type hearing aid is held against the skin behind the ear, or at another bony location of the skull, by pressure from a headband or softband, has been used. The headband is soft plastic while the softband is soft elastic with a plastic disc-like snap connector either modeled or sewn into the band. A BAHA® sound processor is attached to the plastic connector and the band/headband adjusted to the size of the individual's head, secured with a Velcro® fastener (Velcro USA Inc., Manchester, NH).

Background

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 (ASLHA) has defined the degree of hearing loss based on pure-tone average (PTA) detection thresholds as mild (20 to 40 dB), moderate (40 to 60 dB), severe (60 to 80 dB), and profound (greater or equal to 80 dB).

Sound amplification through the use of an air-conduction (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 air-conduction 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 skill via a percutaneous titanium abutment that permanently protrudes through the skin. A sound processor (a hearing aid) attaches to the small titanium implant that is anchored in the temporal bone. Over a period of 3-6 months, the titanium fixture bonds with the surrounding tissue – a process known as osseointegration. The osseointegrated titanium fixture and abutment provide secure attachment of the sound processor 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-conducting hearing aids.

BAHA® sound processors can also be used with the BAHA® Softband or headband. With this application there is no titanium 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, bypassing the outer and middle ear. This application may be used as a pre-surgical trial in children under 5 years of age.

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. To facilitate greater transmission of acoustics between magnets, skin thickness must be reduced to 4-5 mm over the implant when it is surgically placed.

Regulatory Status

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):

  • BAHA® Cordelle II™
  • BAHA® Divino™
  • BAHA® Intenso™ (digital signal processing)
  • BAHA® BP 100™
  • BAHA® 4 (upgraded from the BP 100™)

The FDA cleared 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 1 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 FDA approved 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 cochlea through the bones of the skull. The non-surgical/transcutaneous application of the BAHA® processor using a headband or softband received FDA clearance in 2002 for use in children under the age of 5 years.

In November 2008, the OBC Bone Anchored Hearing Aid System (Oticon Medical, Kongebakken, Denmark) was cleared by the U.S. Food and Drug Administration (FDA) for marketing through the 510(k) process. Subsequently, additional bone conduction hearing systems have received 510(k) marketing clearance from the 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 the 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 (e.g., 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:

  • Otomag® Bone Conduction Hearing System
  • BAHA® Attract

Scope

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Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This policy does not apply to Medicare Advantage.

Benefit Application

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A bone-conduction (bone-anchored) hearing aid is a surgically implantable device to treat a medical condition. The device and implantation surgery should be reimbursed under the medical benefit.

Benefit limitations regarding hearing aids may apply to these devices, specifically when the Implantable Bone- Conduction and Bone-Anchored Hearing Aid (BAHA®) device is used transcutaneously (on the surface of the skin of the head) held in place by a headband or softband and not implanted.

Usual frequency of replacement for BAHA parts

Replacement Parts

Life Expectancy

Batteries

72 per 6 months

Headband

1 per year

Processor

1 per 5 years

Adapted from Wisconsin Department of Health Services, available on line at: https://www.forwardhealth.wi.gov/WIPortal/Online%20Handbooks/Print/tabid/154/Default.aspx?ia=1&p=1&sa=28&s=2&c=10&nt=Cochlear+Implant+and+Bone-Anchored+Hearing+Aid+Surgeries. Last accessed February 18, 2014.

Rationale

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Literature Review

This policy was created in March 2013 and updated regularly based on searches of the MEDLINE database. The most recent literature search was performed through February 2014. No randomized controlled trials (RCTs) have compared implantable bone-conduction hearing aids to other hearing augmentation devices, or sham devices. The literature is characterized by observational studies that report pre-hearing and post-hearing outcomes in patients treated with bone-anchored hearing aids (BAHA). Many of these studies combine patients with differing underlying disease states and indications. Following is a summary of key findings.

Mixed etiologies of hearing loss

Systematic Reviews and Meta-Analysis

A systematic review by the Health Technology Assessment Program was published in 2011 on the use of BAHAs for bilateral hearing impairment. (1, 2) The authors noted that the quality of available studies on the use of BAHAs is weak. No studies with control groups were identified for the review. Cohort pre-post studies and cross-sectional comparative studies demonstrate improvements in hearing with use of BAHAs over conventional bone-conduction hearing aids or unaided hearing. However, whether improvements in hearing with BAHAs are greater than air-conduction hearing aids is uncertain. Additionally, bilateral use of BAHAs improved hearing outcomes in some patients over unilateral use, but the evidence was uncertain. Implant loss was noted to be between 6.1% and 19.4%. The authors noted hearing-specific quality of life improved, but overall quality of life did not differ.

In 2103 Kiringoda et al reported on a meta-analysis of complications related to BAHA implants. Included in the meta-analysis were 20 studies that evaluated complication in 2134 adult and pediatric patients who received a total of 2310 BAHA implants. While the quality of available studies was considered poor and lacking in uniformity, complications related to BAHA implants were mostly minor skin reactions.(3) Holgers Grade 2 to 4 skin reactions were reported to occur from 2.4% to 38.1% in all studies. Zero to 18% of implants failed osseointegration in adult and mixed population studies while 0% to 14.3% failed osseointegration in pediatric population studies. Adult and mixed population studies reported revision surgery was required in 1.7% to 34.5% of cases while pediatric population studies reported required revision surgery in 0.0% to 44.4% of cases. Implant loss occurred in 1.6% to 17.4% in adult and mixed population studies and from 0.0% to 25% in pediatric studies.

Observational studies

In 2010, Ramakrishnan and colleagues retrospectively reviewed bone-anchored and Softband-held conductive hearing aids in 109 children and young adults in a single center. (4) The patient population was somewhat unique in that many patients had craniofacial or genetic syndromes in addition to hearing loss (22 of 109). Criteria for the selection of the implanted device or the Softband were not described; however, the authors did note an uneven distribution by mean age, gender, and syndromic co-morbidity. Primary measures were the Glasgow Benefit Inventory or Listening Situation Questionnaire (parent version) administered at least 3 months following hearing aid intervention. Mean overall Glasgow Benefit Inventory scores were reported as +29 (range +11 to +72). The mean Listening Situation Questionnaire score of 17 was reported as less than a referral cutoff of 22. The authors conclude that this population benefits from bone-anchored and Softband-held conductive hearing aids based on mean scores. However, the study is limited due to a hetereogeneous patient population, a lack of pre-intervention measures, or a controlled comparator group.

In 2004, McLarnon and colleagues reported outcomes (benefits) for BAHAs by patient subgroups based on 69 of 94 (73%) patients who completed a questionnaire. (5) This study noted the greatest benefit in those with congenital ear disorders. It also showed benefit to restoring stereo hearing to patients with an acquired unilateral hearing loss after acoustic neuroma surgery.

In 2008, Tringali and colleagues surveyed patients using a BAHA to compare patient satisfaction by indication: 52 respondents with conductive or mixed hearing loss (44 with chronic otitis and 8 with malformation of the middle ear) compared with 118 with single-sided deafness (SSD) (2 after surgery for meningioma, idiopathic sudden deafness, and sensorineural hearing loss complicating surgery of the middle ear). (6) Levels of satisfaction and quality of life were significantly poorer in the SSD than in the conductive hearing loss (CHL) group, although generally good with the exception of sound localization.

Moderate to Severe Conductive or Mixed Hearing Loss

Reported studies have suggested that the bone-anchored hearing aid (BAHA®) is associated with improved hearing outcomes compared to external bone-conduction hearing aids and equivalent outcomes compared to a conventional air-conduction hearing aid. (7-10)

Bilateral Devices in Conductive or Mixed Hearing Loss

Use of bilateral devices has been evaluated in patients with conductive or mixed hearing losses. A number of studies, published over several years, have demonstrated a consistent improvement in speech recognition in noise and in sound localization with bilateral devices

Janssen et al (2012) conducted a systematic review to assess the outcomes of bilateral versus unilateral BAHA for individuals with bilateral permanent conductive hearing loss (CHL). (11) Their search strategy included studies of all languages published between 1977 and July 2011. Studies were included if subjects of any age had permanent bilateral CHL and bilateral implanted BAHAs. Outcome measures of interest were any subjective or objective audiologic measures, quality of life indicators, or reports of adverse events. Eleven studies met their inclusion criteria. All 11 studies were observational. There were a total of 168 patients in the 11 studies, 155 of whom had BAHAs and 146 of whom had bilateral BAHAs. In most studies, comparisons between unilateral and bilateral BAHA were intra-subject. Patients ranged from 5 to 83 years of age; 46% were male, and 54% were female. Heterogeneity of the methodologies between studies precluded meta-analysis, therefore a qualitative review was performed. Results from 3 of 11 studies were excluded from synthesis because their patients had been included in multiple publications. Adverse events were not an outcome measure of any of the included studies. (11) In general, bilateral BAHA was observed to provide additional objective and subjective benefit compared to unilateral BAHA. For example, the improvement in tone thresholds associated with bilateral BAHA® ranged from 2-15dB, the improvement in speech recognition patterns ranged from 4-5.4dB, and the improvement in the Word Recognition Score ranged from 1-8%. However, these results were based on a limited number of small observational studies consisting of heterogeneous patient groups that varied in age, severity of hearing loss, etiology of hearing loss, and previous amplification experience. (11)

Examples of individual studies include the following. In 2001, Bosman and others reported on findings from 25 patients who were using bilateral devices. (12) They found that both speech recognition in noise and directional hearing improved with the second device. In a 2004 publication, Priwin and colleagues reported similar findings in 12 patients with bilateral devices. (13) A consensus statement published in 2005 concluded that bilateral devices resulted in binaural hearing with improved directional hearing and improved speech-in-noise scores in those with bilateral conductive hearing loss and symmetric bone-conduction thresholds. (13) A number of additional studies that are cited in this report found benefits similar to those noted in the studies of the Bosman et al. and Priwin et al. reports. (12, 13) Positive outcomes continue to be reported: Dun and colleagues (14) identified improvements in the Glasgow Benefit Inventory in children (n=23), while Ho and colleagues (16) report the same benefit in adults (n=93). Thus, based on these numerous studies, bilateral devices may be considered medically necessary when there is bilateral conductive or mixed hearing loss with symmetric bone-conduction thresholds.

Unilateral Sensorineural Hearing Loss

Several centers have reported on findings from observational studies designed to evaluate the benefits of BAHA for patients with unilateral sensorineural hearing loss (single-sided deafness). Most of these studies have been retrospective. In one prospective study conducted within a hospital auditory implant center in the United Kingdom, Pai and colleagues reported significant improvement in the average score in all three sections (speech hearing, spatial hearing, other qualities) of the SSQ questionnaire following a BAHA implant in 25 adult patients. (17)

Zeitler et al reported on a retrospective case series of 180 patients undergoing unilateral or bilateral BAHA for single-sided deafness with residual hearing in the implanted ear within a university medical center in the US. (18) Significant improvement was reported in objective hearing measures (speech-in-noise and monosyllabic word tests) following BAHA® implantation. Subjective benefits from BAHA® varied across patients according to results from the Glasgow Hearing Aid Benefit Profile but patients with residual hearing in the affected ear tended toward improved satisfaction with their device postoperatively. (18) Nicolas and colleagues undertook a retrospective review of 36 patients implanted with a BAHA® within a university medical center in France. (19) Their results showed an improvement in speech perception in noise with the BAHA®, but no improvement in sound localization based on a 2-year follow-up period. (19)

Baguley et al reviewed the evidence for contralateral BAHAs® in adults with acquired unilateral sensorineural hearing loss. (20) None of the four controlled trials reviewed showed a significant improvement in auditory localization with the bone-anchored device. However, speech discrimination in noise and subjective measures improved with these devices; for these parameters, the BAHAs resulted in greater improvement than that obtained with the conventional air-conduction contralateral routing of signal (CROS) systems. The authors of this review did note shortfalls in the studies reviewed.

Lin et al reported on use of the BAHAs in 23 patients with unilateral deafness, and noted that speech recognition in noise was significantly better with the BAHA® device than with the air-conduction CROS device. (21) 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 five patients. Larger studies are needed before changes can be considered in the policy statement regarding use in this clinical situation.

Two studies of BAHAs® for congenital unilateral conductive hearing impairment are reported by Kunst and colleagues. In one study, aided and unaided hearing was assessed in 20 patients using sound localization and speech recognition-in-noise tests. (22) Many patients showed unexpectedly good unaided performance, however non-significant improvements were observed in favor of the BAHA. Six of 18 patients with a complete data set did not show any improvement at all; however compliance with BAHA use in this patient group was remarkably high suggesting patient benefit. The same authors evaluated 10 adults and 10 children using 2 disability-specific questionnaires and found an overall preference for the BAHA over unaided hearing in several specific hearing situations. (22) Improvement on the Glasgow children’s benefit inventory was most prominent in the learning domain. The 10 adults showed an already good score on the Speech, Spatial and Qualities of hearing scale in the unaided situation.

In 2010, Gluth et al reported on 21 patients with profound unilateral sensorineural hearing loss followed for an average of 3.2 years after BAHA implantation. (23) Perceived benefits and satisfaction were reported to improve significantly in BAHA® users, and 81% continued using the device long term. However, severe local skin reactions were frequently experienced (38% Grade 2 and above).

Children under Five Years of Age

A 2008 review article notes that for children younger than 5 years, other solutions (such as a bone conductor with transcutaneous coupling) should be utilized. (24) This recommendation is in agreement with the U.S. Food and Drug Administration (FDA) clearance of the osseointegration implant only for children 5 years of age and older, and adults. This is reflected in the policy statements.

The BAHA device has been investigated in children younger than 5 years in Europe and the United Kingdom. A number of reports describe experience with preschool children or children with developmental issues that might interfere with maintenance of the device and skin integrity. A 2-stage procedure is used in young children. In the first stage, the fixture is placed into the bone and allowed to fully develop osseointegration. After 3-6 months, a second procedure is performed to connect the abutment through the skin to the fixture.

Marsella et al have reported on their center’s experience in Italy with pediatric BAHA from the inception of their program in 1995 to December 2009. (25) A total of 47 children (21 females and 26 males) were implanted, seven of these were younger than 5 years. The functional gain was significantly better with BAHA than conventional bone-conduction hearing aids and there was no significant difference in terms of functional outcome between the seven patients receiving a BAHA at an age younger than five years and the rest of the patient cohort. Based on these findings, the study authors suggest that implantation of children at an age younger than five years can be conducted safely and effectively in such settings. (25) The conclusions are limited by the small number of children less than 5 years of age in the study and the limited power to detect a difference between younger and older children.

Davids et al at the University of Toronto provided BAHA devices to children less than 5 years of age for auditory and speech-language development and retrospectively compared surgical outcomes for a study group of 20 children 5 years or younger and a control group of 20 older children. (26) Children with cortical bone thickness greater than 4 mm underwent a single-stage procedure. The interstage interval for children having 2-stage procedures was significantly longer in the study group in order to allow implantation in younger patients without increasing surgical or postoperative morbidity. Two traumatic fractures occurred in the study group versus 4 in the older children. Three younger children required skin site revision. All children were wearing their BAHA® devices at time of writing. McDermott et al. reported on the role of bone anchored hearing aids in children with Down syndrome in a retrospective case analysis and postal survey of complication rates and quality of life outcomes for 15 children aged 2 to 15 years. (27) All patients were using their BAHA® devices after follow-up of 14 months. No fixtures were lost; skin problems were encountered in 3 patients. All 15 patients had improved social and physical functioning attributed to improved hearing.

Adverse Events

In 2012, Dun et al assessed soft tissue reactions and implant stability of 1,132 percutaneous titanium implants for bone conduction devices through a retrospective survey of 970 patients undergoing implants between September 1988 and December 2007 at the University Medical Center in the Netherlands. (28) The study investigators also examined device usage and comparisons between different patient age groups (children, adults, and the elderly) over a five-year follow-up period. Implant loss was 8.3%. In close to 96% of cases, there were no adverse soft tissue reactions. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). (28)

In 2010, Hobson et al reviewed complications on 602 patients at a tertiary referral center over 24 years and compared their observed rates to those published in 16 previous studies. (29) The overall observed complication rate of 23.9 % (144 of 602) is similar to other published studies (complication rate 24.9% + 14.85). The most common complications were soft tissue overgrowth, skin infection, and fixture dislodgement. The observed rate of revision surgery of 12.1% (73 of 602) was also similar to previously published rates of 12.7%. Top reasons for revision surgery were identical to observed complications. In 2011, Wallberg et al. reported on the status of 150 implants placed between 1977 and 1986 and followed for a mean of 9 years. (30) Implants were lost in a total of 41 patients (27%). The reasons for implant loss were: removal in 16 patients, osseointegration failure in 17 patients, and direct trauma in 8 patients. In the remainder of 132 patients with implant survival, BAHAs were still being used by 119 patients (90%) at the end of follow-up. For children, implant complications were even more frequent, as reported by Kraai et al. in a follow-up evaluation of 27 implants placed in children ages 16 years or younger between 2002 and 2009. (31) In this retrospective report, soft tissue reactions occurred in 24 patients (89%); removal of the implant or revision surgery was required in 10 patients (37%); 24 patients (89%) experienced soft tissue overgrowth and infection; and 7 patients experienced implant trauma. Chronic infection and overgrowth at the abutment prevented use of the implant in 3 patients (11%).

Partially Implantable Magnetic Bone Conduction Hearing Aids

In 2011, Seigert reported on the use of a partially implantable bone conduction hearing system (Otomag®) that uses magnetic coupling for acoustic transmission. (32) This hearing system is reported to have been implanted in more than 100 patients followed in the past 5 years, but results are only presented on 12 patients. Since the acoustics must pass through the skin rather than by direct bone stimulation through an abutment on the BAHA-type implants, Seigert reports sound attenuation is reduced by less than 10 dB. The preliminary results of the partially implantable hearing system in 8 unilaterally and 4 bilaterally implanted patients showed average hearing gains of 31.2 ± 8.1 dB in free field pure tone audiogram. The free field suprathreshold speech perception at 65 dB increased from 12.9% preimplantation to 72.1% postimplantation.

In 2013 Hol et al reported on a comparison of BAHA percutaneous implants to partially implantable magnetic

transcutaneous bone-conduction hearing implants using the Otomag® Sophono device in 12 pediatric patients, ranging in age from 5 to 12 years, with congenital unilateral CHL. (33) Sound field thresholds, speech recognition threshold and speech comprehension at 65 dB were somewhat better in patients with the BAHA implant (n=6) than the partially implantable hearing implant (n=6). Using a skull simulator, output was 10 to 15 dB lower with the partially implantable device than the BAHA device.

Non-implanted BAHA with Softband

In 2010, Christensen et al reported on a retrospective five-year case review of ten children, with ages ranging from 6 months to 16 years of age, with bilateral conductive hearing loss due to congenital aural atresia (CAA) and/or microtia. The case-review study participants initially trialed the use of traditional bone-conduction hearing aids, then proceeded to the externally worn BAHA® with Softband™, and eventually to a unilateral implanted BAHA®. The devices were assessed for functional gain and hearing threshold measures at 500, 1000, 2000, and 4000 Hz frequencies. The findings of the report showed a statistically significant improvement when using the externally worn BAHA® with Softband™ over traditional bone-conduction hearing aids. (34)

Ongoing Clinical Trials

A search of online site ClinicalTrials.gov at the time of the 2014 policy review found several ongoing studies.

Studies for bone-conduction hearing implant devices

  • NCT01715948 This study is a small randomized trial in Canada comparing the effect of BAHA® and a Contralateral Routing of Signals (CROS) hearing aid in single-sided deafness. Expected enrollment for this study is 10 patients, but is not yet open for participant recruitment.
  • NCT01933386 This Phase IV RCT study will compare the SoundBite™ Hearing system to a surgically implanted bone-conduction device. Expected enrollment for this study is 15 patients, but is not yet open for participant recruitment.
  • NCT01264510 This study is a Phase IV open study evaluating the effectiveness of bone-anchored hearing aids for conductive or mixed hearing loss, or unilateral deafness. Expected enrollment for this study is 150 patients, with an estimated completion date of August 2013.

Studies for partially implantable transcutaneous BAHA

  • NCT01822119 This study will evaluate the BAHA® Attract sound processor used with a softband compared to the unaided hearing performance before surgery. Expected enrollment for this study is 22 patients, with an estimated completion date of February 2014.
  • NCT01858246 This study is an RCT to evaluate a conventional bone-conduction hearing device compared with a new partially implantable transcutaneous bone-conduction hearing implant (Vibrant Bonebridge™). Expected enrollment for this study is 60 patients, but is not yet open for participant recruitment.

Summary

Bone-conduction hearing aids function by transmitting sound waves through the bone to the ossicles of the middle ear. The available evidence for unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) consists of observational studies that report pre- post differences in hearing parameters after treatment with BAHA. While this evidence is not idea, it is sufficient to demonstrate improved net health outcome for patients 5 years of age or older in certain situations. The evidence supports the use of these devices in patients with conductive or mixed hearing loss who meet other medical and audiologic criteria. For patients with single-sided sensorineural deafness, a binaural hearing benefit may be provided by way of contralateral routing of signals to the hearing ear. There is evidence that bilateral devices improve hearing to a greater degree than do unilateral devices. Bone-anchored hearing aids may be considered as an alternative to air-conduction devices in these patients. Due to the lack of both high-quality evidence and FDA approval, other uses of implanted bone-conduction (bone-anchored) hearing aids, including use in children younger than 5 years and patients with bilateral sensorineural hearing loss, BAHA are unproven. In hearing impaired children younger than 5 years of age, to facilitate early speech and language development, the use of a BAHA® with a headband or softband as a presurgical trial may be warranted based on a review of the medical records.

The available evidence for partially implantable bone-conduction hearing systems is preliminary and very limited. Therefore, conclusions on net health outcomes cannot be made, and partially implantable bone-conduction hearing systems are considered investigational.

Medicare National Coverage

No national coverage determination was found at the time this policy was developed.

Please refer to The Medicare Benefit Policy Manual (35) for information about Medicare coverage, benefits and exclusions.

References

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  1. Colquitt JL, Loveman E, Baguley DM et al. Bone-anchored hearing aids for people with bilateral hearing impairment: a systematic review. Clin Otolaryngol 2011; 36(5):419-41.
  2. Colquitt JL, Jones J, Harris P et al. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technol Assess 2011; 15(26):1-200, iii-iv.
  3. Kiringoda R, Lustig LR. A meta-analysis of the complications associated with osseointegrated hearing aids.
  4. Neurotol 2013; 34(5):790-4.
  5. Y, Marley S, Leese D et al. Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. J Laryngol Otol 2011; 125(2):153-7.
  6. CM, Davison T, Johnson IJ. Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope 2004; 114(5):942-4.
  7. S, Grayeli AB, Bouccara D et al. A survey of satisfaction and use among patients fitted with a BAHA. Eur Arch Otorhinolaryngol 2008; 265(12):1461-4.
  8. AF, Mylanus EA, Cremers CW. The bone-anchored hearing aid compared with conventional hearing aids. Audiologic results and the patients' opinions. Otolaryngol Clin North Am 1995; 28(1):73-83.
  9. JJ, Caruso M, Tjellstrom A. Long-term results with the titanium bone-anchored hearing aid: the U.S. experience. Am J Otol 1998; 19(6):737-41.
  10. der Pouw CT, Snik AF, Cremers CW. The BAHA HC200/300 in comparison with conventional bone conduction hearing aids. Clin Otolaryngol Allied Sci 1999; 24(3):171-6.
  11. G, Tjellstrom A. The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J 1997; 76(4):238-40, 42, 44-7.
  12. RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing loss: a systematic review. Otolaryngol Head Neck Surg 2012; 147(3):412-22.
  13. AJ, Snik AF, van der Pouw CT et al. Audiometric evaluation of bilaterally fitted bone-anchored hearing aids. Audiology 2001; 40(3):158-67.
  14. C, Stenfelt S, Granstrom G et al. Bilateral bone-anchored hearing aids (BAHAs): an audiometric evaluation. Laryngoscope 2004; 114(1):77-84.
  15. AF, Mylanus EA, Proops DW et al. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl 2005; 195:2-12
  16. CA, de Wolf MJ, Mylanus EA et al. Bilateral bone-anchored hearing aid application in children: the Nijmegen experience from 1996 to 2008. Otol Neurotol 2010; 31(4):615-23.
  17. EC, Monksfield P, Egan E et al. Bilateral Bone-anchored Hearing Aid: impact on quality of life measured with the Glasgow Benefit Inventory. Otol Neurotol 2009; 30(7):891-6.
  18. I, Kelleher C, Nunn T et al. Outcome of bone-anchored hearing aids for single-sided deafness: a prospective study. Acta Otolaryngol 2012; 132(7):751-5.
  19. DM, Snapp HA, Telischi FF et al. Bone-anchored implantation for single-sided deafness in patients with less than profound hearing loss. Otolaryngol Head Neck Surg 2012; 147(1):105-11.
  20. S, Mohamed A, Yoann P et al. Long-term benefit and sound localization in patients with single-sided deafness rehabilitated with an osseointegrated bone-conduction device. Otol Neurotol 2013; 34(1):111-4.
  21. DM, Bird J, Humphriss RL et al. The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol 2006; 31(1):6-14.
  22. LM, Bowditch S, Anderson MJ et al. Amplification in the rehabilitation of unilateral deafness: speech in noise and directional hearing effects with bone-anchored hearing and contralateral routing of signal amplification. Otol Neurotol 2006; 27(2):172-82.
  23. SJ, Leijendeckers JM, Mylanus EA et al. Bone-anchored hearing aid system application for unilateral congenital conductive hearing impairment: audiometric results. Otol Neurotol 2008; 29(1):2-7.
  24. MB, Eager KM, Eikelboom RH et al. Long-term benefit perception, complications, and device malfunction rate of bone-anchored hearing aid implantation for profound unilateral sensorineural hearing loss. Otol Neurotol 2010; 31(9):1427-34.
  25. A, Leijendeckers J, Hol M et al. The bone-anchored hearing aid for children: recent developments. Int J Audiol 2008; 47(9):554-9.
  26. P, Scorpecci A, Pacifico C et al. Pediatric BAHA in Italy: the "Bambino Gesu" Children's Hospital's experience. Eur Arch Otorhinolaryngol 2012; 269(2):467-74.
  27. T, Gordon KA, Clutton D et al. Bone-anchored hearing aids in infants and children younger than 5 years. Arch Otolaryngol Head Neck Surg 2007; 133(1):51-5.
  28. AL, Williams J, Kuo MJ et al. The role of bone anchored hearing aids in children with Down syndrome. Int J Pediatr Otorhinolaryngol 2008; 72(6):751-7
  29. CA, Faber HT, de Wolf MJ et al. Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. Otol Neurotol 2012; 33(2):192-8.
  30. JC, Roper AJ, Andrew R et al. Complications of bone-anchored hearing aid implantation. J Laryngol Otol 2010; 124(2):132-6.
  31. E, Granstrom G, Tjellstrom A et al. Implant survival rate in bone-anchored hearing aid users: long-term results. J Laryngol Otol 2011; 125(11):1131-5.
  32. T, Brown C, Neeff M et al. Complications of bone-anchored hearing aids in pediatric patients. Int J Pediatr Otorhinolaryngol 2011; 75(6):749-53.
  33. R. Partially implantable bone conduction hearing aids without a percutaneous abutment (Otomag): technique and preliminary clinical results. Adv Otorhinolaryngol 2011; 71:41-6.
  34. MK, Nelissen RC, Agterberg MJ et al. Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol 2013; 34(6):1071-5.
  35. L, Smith-Olinde L, Kimberlain J, et al. Comparison of traditional bone-conduction hearing AIDS with the Baha system. J Am Acad Audiol. 2010; 21(4):267-273.
  36. Policy Benefit Manual. Chapter 16 - General Exclusions from Coverage. Available online at: http://www.cms.gov/manuals/Downloads/bp102c16.pdf. Last accessed February 19, 2014.
  37. BlueShield Association (BCBSA). Implantable Bone-Conduction and Bone-Anchored Hearing Aids. Medical Policy Reference Manual, Policy No. 7.01.03, 2014

Coding

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Codes

Number

Description

CPT

69710

Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone

 

69711

Removal or repair of electromagnetic bone conduction hearing in temporal bone

 

69714

Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy

 

69715

with mastoidectomy

 

69717

Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy

 

69718

with mastoidectomy

HCPCS

L8690

Auditory osseointegrated device, includes all internal and external components

 

L8691

Auditory osseointegrated device, external sound processor, replacement

 

L8692

Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment

 

L8695

External recharging system for battery (external) for use with implantable neurostimulator

Type of Service

Surgery

Prosthetic

 

Place of Service

Outpatient

 

Appendix

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Figure 1. Implanted used of BAHA Figure 2. Transcutaneous use of BAHA with Softband

History

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Date

Reason

10/09/12

New policy. Policy includes statement about medical necessity criteria for use of BAHA with headband or softband for children less than 5 years of age; that was not addressed in the BC policy. A table of frequency of BAHA replacement parts is included in the benefit application section. This policy replaces 7.01.03.

03/08/13

Replace policy. Updated with literature review and references renumbered. Policy statements unchanged.

03/25/14

Replace policy. Added the word magnetic and the BAHA Attract device to the Investigational policy statement. Clarified Benefit Application statement. Rationale updated with literature review through February 2014, simplified Medicare National Coverage statement. References 3, 33 added; others renumbered/removed. Code 20.95 was removed per ICD-10 mapping project; this code is not utilized for adjudication of policy. Policy statement changed as noted. ICD-9 and ICD-10 codes removed from the policy; these are not utilized in adjudication and were informational only.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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