Implantable Bone Conduction and Bone-Anchored Hearing Aids
*Medicare has a policy.
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:
Meet the following audiologic criteria:
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:
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).
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.
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).
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)
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).
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.
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):
The FDA cleared the BAHA® system for the following indications:
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
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 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
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.
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.
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.
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
Studies for partially implantable transcutaneous BAHA
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.
Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
Removal or repair of electromagnetic bone conduction hearing in temporal bone
Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy
Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy
Auditory osseointegrated device, includes all internal and external components
Auditory osseointegrated device, external sound processor, replacement
Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment
External recharging system for battery (external) for use with implantable neurostimulator
Type of Service
Place of Service
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.
Replace policy. Updated with literature review and references renumbered. Policy statements unchanged.
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).