Coverage Policy Manual
Policy #: 2002029
Category: Surgery
Initiated: November 2002
Last Review: July 2022
  Implantable Bone Conduction Hearing Aids

Description:
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. An implantable, bone-anchored hearing aid has been investigated as an alternative to conventional bone-conduction hearing aids.
 
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. 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.
 
A bone-anchored implant system combines a vibrational transducer coupled directly to the skull via a percutaneous abutment that permanently protrudes through the skin from a small titanium implant anchored in the temporal bone. The system is based on osseointegration through which living tissue integrates with titanium in the implant over a period of 3 to 6 months, conducting amplified and processed sound 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-conduction hearing aids. Implantable bone-conduction hearing systems are primarily indicated for people with conductive or mixed sensorineural/conductive hearing loss. They may also be used with CROS as an alternative to an AC hearing aid with CROS for individuals with unilateral sensorineural hearing loss.
 
Partially implantable magnetic bone-conduction hearing systems, also referred to as transcutaneous bone-anchored systems, are an alternative to bone-conduction hearing systems that connect to bone percutaneously via an abutment. With this technique, acoustic transmission occurs transcutaneously via magnetic coupling of the external sound processor and the 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. Because 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 may be reduced to 4 to 5 mm over the implant when it is surgically placed.
 
Regulatory Status
Several implantable bone-conduction hearing systems have been approved by the U.S. Food and Drug Administration (FDA) for marketing through the 510(k) process.
 
    • Baha® Auditory Osseointegrated Implant System (Cochlear Americas)  
    • BA310 Abutment, BIA310 Implant/Abutment cleared December 2018 (K182116)
    • Baha 5 Power Sound Processor cleared May 2016 (K161123)
    • Baha 5 Super Power Sound Processor cleared March 2016 (K153245)
    • Baha® 5 Sound Processor cleared March 2015 (K142907)
    • Baha® Attract System cleared November 2013 (K131240)
    • Baha® Cordelle II cleared July 2015 (K150751) and April 2008 (K080363)
    • Baha Divino® cleared August 2004 (K042017)
    • Baha Intenso® (digital signal processing) cleared August 2008 (K081606)
    • Baha® 4 (upgraded from the BP100) cleared September 2013 (K132278)
    • Cochlear™ Osia™2 System cleared December 2019 (K191921)
    • OBC Bone-Anchored Hearing Aid System (Oticon Medical) cleared November 2011 (K112053)
    • Ponto Bone-Anchored Hearing System (Oticon Medical) cleared September 2012 (K121228)
    • Ponto 4 cleared May 2019
    • Ponto 3, Ponto 3 Power and Ponto 3 SuperPower cleared September 2016 (K161671)
 
Product codes: MAH, LXB
 
The FDA cleared the majority of these systems for use in children ages 5 years and older and adults 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 (ie, single-sided deafness);
    • Patients who are candidates for an AC CROS hearing aid but who cannot or will not wear an AC CROS device.
 
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 via the bones of the skull. In 2020, the BAHA® Softband™ was cleared for marketing by FDA for use in children younger than 5 years. Because this application has no implanted components, it is not addressed in the policy.
 
The most recently cleared Osia™2 system may be used by adults and children 12 years of age and older with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness.
 
The FDA also cleared 3 partially implantable magnetic bone-conduction devices for marketing through the 510(k) process.
 
    • Bonebridge by MED-EL cleared March 2019 (K183373)
    • Otomag® Bone-Conduction Hearing System by Medtronic (Formerly Sophono) cleared November 2013 (K132189)
    • Cochlear Baha® 4 Sound Processor by Cochlear Americas cleared October 2012 (K121317)
 
The SoundBite™ Hearing System (Sonitus Medical, San Mateo, CA) is an intraoral bone-conducting hearing prosthesis that consists of a behind-the-ear microphone and an in-the-mouth hearing device. In 2011, it was cleared for marketing by the FDA through the 510(k) process for indications similar to the BAHA. However, the manufacturer, Sonitus Medical, closed in 2015.Because this system has no implanted components, it is not addressed in the current policy.
 
FDA product code (for bone-anchored hearing aid): LXB
FDA product code (for implanted bone-conduction hearing aid): MAH
  
 
Coding
The following CPT codes describe semi-implantable bone-conduction hearing aids:
 
69710: Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone*
69711: Removal or repair of electromagnetic bone conduction hearing device in temporal bone*
*The Audiant bone conductor is a type of electromagnetic bone-conduction hearing device. While this product is no longer actively marketed, patients with existing Audiant devices may require replacement, removal, or repair.
 
The following 2 CPT codes describe the BAHA device:
69714: Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy**
69715: as above, but with mastoidectomy**
 
Effective in 2007, there are HCPCS codes specific to this device:
L8690: Auditory osseointegrated device, includes all internal and external components
L8691: Auditory osseointegrated device, external sound processor, replacement
L8693: Auditory osseointegrated device abutment, any length, replacement only.
 
This policy does not address auditory brain stem implants.  Coverage criteria for auditory brain stem implants can be found in policy #2002013.
 
This policy does not address cochlear implants.  Coverage criteria for cochlear implants can be found in policy #1998070.
 

Policy/
Coverage:
Effective July 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Unilateral or bilateral fully- or partially- implantable bone-conduction (bone-anchored) hearing aid(s) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction hearing aid in patients 5 years of age and older with a conductive or mixed hearing loss who also meet at least one of the following 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).
 
For bilateral implantation, patients should meet the above audiologic criteria, and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
 
An implantable bone-conduction (bone-anchored) hearing aid meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction CROS hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other uses of unilateral or bilateral fully- or partially- implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, other uses of unilateral or bilateral fully- or partially- implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to July 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction hearing aid in patients 5 years of age and older with a conductive or mixed hearing loss who also meet at least one of the following 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).
    • For bilateral implantation, patients should meet the above audiologic criteria, and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
 
An implantable bone-conduction (bone-anchored) hearing aid meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction CROS hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other uses of bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, other uses of bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
 
Partially implantable bone conduction hearing systems using magnetic coupling for acoustic transmission (e.g., Otomag Alpha 1 [M]) do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, partially implantable bone conduction hearing systems using magnetic coupling for acoustic transmission (e.g., Otomag Alpha 1 [M]) are considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
 
Effective January 2011 – September 2013
Unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction hearing aid in patients 5 years of age and older with a conductive or mixed hearing loss who also meet at least one of the following 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).
    • For bilateral implantation, patients should meet the above audiologic criteria, and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
 
An implantable bone-conduction (bone-anchored) hearing aid meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as an alternative to an air-conduction CROS hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.
 
Other uses of bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, other uses of bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
 
Effective November 2007 through December 2010
An implantable bone conduction hearing aid meets member certificate of benefit Primary Coverage Criteria as an alternative to an air conduction hearing aid in the following patients with single-sided deafness and normal hearing in the other ear for members with:
    • Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear;
    • Chronic external otitis or otitis media (requires prior approval to determine if Primary Coverage  Criteria are met);
    • Tumors of the external canal and/or tympanic cavity;
    • Sudden, permanent, unilateral hearing loss due to trauma, idiopathic sudden hearing loss, or auditory nerve tumor;
    • Single-sided sensorineural deafness as an alternative to an air-conduction CROS hearing aid.
 
Other uses of bone-conduction (bone-anchored) hearing aids, including, but not limited to,  use in patients with bilateral sensorineural hearing loss does not meet primary coverage criteria and are not covered.
 
Other uses of bone-conduction (bone-anchored) hearing aids, including. but not limited to, use in patients with bilateral sensorineural hearing loss is considered investigational and not covered for contracts without primary coverage criteria language.  Investigational services are a contract exclusion.
 
Effective January 2007 through October 2007
An implantable bone conduction hearing aid meets member certificate of benefit  Primary Coverage Criteria as an alternative to an air conduction hearing aid in the following patients with single-sided deafness and normal hearing in the other ear:
    • Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear;
    • Chronic external otitis or otitis media (requires prior approval to determine if Primary Coverage  Criteria are met);
    • Tumors of the external canal and/or tympanic cavity
    •  Sudden, permanent, unilateral hearing loss due to trauma, idiopathic sudden hearing loss, or auditory nerve tumor
 
November 2002 through December 2007
Member benefit contracts state hearing aids are an excluded service.  Based on this contract implantable bone conduction hearing aids are considered an ineligible service and are not covered.
 

Rationale:
Hearing results of semi-implantable bone conduction hearing aids may be compared either to:
    • external bone conduction hearing aids in patients with atresias who are  unable to use external air conduction hearing aids, or to
    • external air conduction hearing aids in patients who are unable to tolerate air conduction hearing aids due to chronic infection. Reported studies have suggested that the BAHA device is associated with improved hearing outcomes compared to external bone conduction hearing aids and equivalent outcomes compared to a conventional air conduction hearing aid.
 
2007 Update
The policy was updated based on a literature search using MEDLINE through May 2007. McLarnon reported outcomes (benefits) for bone-anchored hearing aids by patient subgroups based on 69 of 94 (73%) patients who completed a questionnaire (McLarnon, 2004).  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. House reported on  complications from bone-anchored hearing aids (House, 2007).  No intraoperative or perioperative  complications were noted in 149 patients who received the device between 2001 and 2005. Significant postoperative complications, requiring intervention, occurred in 19 patients (13%). Skin overgrowing the abutment occurred in 11 patients, and implant extrusion occurred in 5 patients.
 
Baguley and colleagues reviewed the evidence for contralateral bone-anchored hearing aids in adults with acquired unilateral sensorineural hearing loss (Baguley, 2006).  None of the 4 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 bone-anchored devices resulted in greater improvement than that obtained with  the conventional air-conduction CROS systems. The authors of this review did note shortfalls in the studies reviewed. Lin reported on use of the bone-anchored hearing aids 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 (Lin, 2006).  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 5 patients. Larger studies are needed before changes can be considered in the policy statement regarding use in this clinical situation.
 
2010 Update
The policy was updated based on a literature search using MEDLINE.  None of the information identified leads to a change to the policy statements. Two studies of bone-anchored hearing aids for congenital unilateral conductive hearing impairment are reported by Kunst et al. In 1 study aided and unaided hearing was assessed in 20 patients using sound localization and speech recognition-in-noise tests (Kunst, 2008).  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 showed no 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 (Kunst, 2008).  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. Tringali et al 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 (2 after surgery for meningioma, idiopathic sudden deafness, sensorineural hearing loss complicating surgery of the middle ear) (Tringali, 2008).  Levels of satisfaction and quality of life were significantly poorer in the SSD than in the CHL group, although generally good with the exception of sound localization.
 
The BAHA device has been used successfully in children younger than 5 years in Europe and the United Kingdom. (The most recent [1999] update of the FDA notification lists age less than 5 years as a contraindication.) 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 two-stage procedure is used in young children with the fixture placed into the bone at the first stage and, after 3 to 6 months to allow for osseointegration, a second procedure to connect the abutment through the skin to the fixture. Davids and colleagues 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 (Davids, 2007).  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 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 reported on the role of bone-anchored hearing aides 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 (McDermott, 2008).   All patients are using their BAHA devices after follow-up of 14 months. No fixtures were lost, and skin problems were encountered in 3 patients. All 15 patients had improved social and physical functioning as a result of better hearing.
 
2011 Update
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 (Ramakrishnan, 2010). 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 three 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.
 
Hobson and colleagues 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 (Hobson, 2010). 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.
 
Positive outcomes continue to be reported in the use of bilateral devies in patients with conductive or mixed hearing losses. Dun and colleagues (Dun, 2010) identified improvements in the Glasgow Benefit Inventory in children (n=23), while Ho and colleagues (Ho, 2009) report the same benefit in adults (n=93).
 
The available evidence for unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) 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. A binaural hearing benefit may be provided to patients with single-sided sensorineural deafness by way of contralateral routing of signals to the hearing ear. Bone-anchored hearing aids may be considered as an alternative to air-conduction devices in these patients. Given the lack of both high quality evidence and FDA approval the coverage statement regarding other uses of bone-conduction (bone-anchored) hearing aids in patients with bilateral sensorineural hearing loss is unchanged. Coverage statement was clarified to exclude patients under the age of 5 years due to the lack of evidence and FDA approval of the devices.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database was conducted through September 2013. The following is a summary of the key identified literature.
 
Bilateral Devices in Conductive or Mixed Hearing Loss
Janssen and colleagues (2012) conducted a systematic review to assess the outcomes of bilateral versus unilateral BAHA for individuals with bilateral permanent conductive hearing loss (CHL) (Janssen, 2012). 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 (Janssen, 2012). 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 (Janssen, 2012).
   
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 spatial and qualities of hearing scale SSQ questionnaire following a BAHA implant in 25 adult patients (Pai, 2012).
 
Zeitler and colleagues 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 U.S (Zeitler, 2012). 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 (Zeitler, 2012). Nicolas and colleagues undertook a retrospective review of 36 patients implanted with a BAHA within a university medical center in France (Nicolas, 2013). 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 (Nicolas, 2013).
 
Children Younger Than Age 5 Years
Marsella and colleagues have reported on their center’s experience in Italy with pediatric BAHA from the inception of their program in 1995 to December 2009 (Marsella, 2012). A total of 47 children (21 females and 26 males) were implanted; 7 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 7 patients receiving a BAHA at an age younger than 5 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 5 years can be conducted safely and effectively in such settings (Marsella, 2012). 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.
 
Adverse Events
In 2012, Dun and colleagues 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 (Dun, 2012). The study investigators also examined device usage and comparisons between different patient age groups (children, adults, and elderly patients) over a 5-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 elderly patients (p<0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p=0.001) (Dun, 2012).
 
Partially Implantable Bone Conduction Hearing Aids
In 2011, Seigert reported on the use of a partially implantable bone conduction hearing system that uses magnetic coupling for acoustic transmission (Seigert, 2011). 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. The available evidence for partially implantable bone-conduction hearing systems is preliminary and very limited. Therefore, conclusions on net health outcomes cannot be made. The coverage statement has been changed to address partially implantable bone-conduction hearing systems.
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov found 2 ongoing studies. The first study is a small randomized trial being undertaken in a Canadian tertiary university center comparing the effect of BAHA and a Contralateral Routing of Signals (CROS) hearing aid on speech perception scores when listening to speech in quiet and in noise. (NCT01715948) This trial will also investigate patients' reported benefits with each device during everyday situations. In order to compare the BAHA and CROS, users of BAHA will be given a 2-week trial period with the ‘Unitron Tandem’ CROS hearing aid. Participants will be randomly assigned to wear either their BAHA for 2 weeks or the trial CROS for 2 weeks. Expected enrollment for this study is 10 patients, with an estimated trial completion date of December 2013.
 
The second study is a Phase IV open study evaluating the effectiveness of bone-anchored hearing aids for conductive or mixed hearing loss, or unilateral deafness. (NCT01264510) The status of this latter study is ongoing, but not recruiting participants. Expected enrollment for this study is 150 patients with an estimated initial completion date of August 2013.
  
2014 Update  
 
A literature search conducted through January 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
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 (Kiringoda, 2013). 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 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 (Hol, 2013). 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.
 
Two studies were identified that will evaluate a partially implantable transcutaneous bone-conduction hearing implant. One study will evaluate the BAHA Attract in 22 patients (NCT01822119). A conventional bone-conduction hearing device will be compared with a new partially implantable transcutaneous bone-conduction hearing implant (Vibrant Bonebridge™) in an RCT of 60 patients (NCT01858246).
    
2015 Update
 
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The evidence related to the use of bone-anchored hearing aid (BAHA) devices is characterized by observational studies that report pre- and post-implant hearing outcomes in patients treated with BAHA. Many of these studies combine patients with differing underlying disease states and indications. No randomized controlled trials (RCTs) have compared implantable bone-conduction hearing aids to other hearing augmentation devices, or sham devices.
 
Since the publication of the Health Technology Assessment Program systematic review, a number of observational studies have evaluated specific aspects of BAHA implantation or reported outcomes in specific populations. Several observational studies have suggested that newer-generation BAHAs with fully digital signal processors improve hearing to a greater degree than earlier-generation devices (Kompis, 2014; Hill-Feltham, 2014).
 
In 2014, Farnoush et al retrospectively compared BAHA placement with reconstruction of the external auditory canal for children and adolescents with congenital aural atresia or stenosis who were treated at a single institution from 1988 to 2011 (Farnoush, 2014). Sixty-eight patients were included, 49 who underwent external auditory canal reconstruction (EACR) and 19 who received a BAHA. Groups differed significantly in terms of age, presence of bilateral atresia, and presence of an associated syndrome. Audiologic data were available for 41 patients. At short-term (<6 months post-surgery) follow-up, the BAHA group had larger hearing gains on AC than the EACR group (44.3 dB vs 20.0 dB; p<0.001); similarly, the BAHA group had larger hearing gains at long term (>1 year post-surgery) follow-up (44.5 dB vs 15.3 dB; p<0.001). Quality-of-life scores and requirements for revision surgery did not differ significantly between the groups.
 
Case series have suggested that the BAHA is was associated with improved hearing compared with earlier generations of bone-conducting devices and AC hearing aids, (Snik, 1999; van der Pouw , 1999) and produce acceptable hearing outcomes in individuals unable to receive an AC hearing aid (Wazen, 1998; Granstrom, 1997).
 
Efficacy of BAHA Devices for 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, or SSD. Most of these studies have been retrospective. In 2014, Peters et al reported results from a systematic review of the use of BAHA devices with contralateral routing of sound systems for SSD (Peters, 2014). The authors included 6 studies that met eligibility criteria, 5 of which were considered to have moderate to high directness of evidence and low to moderate risk of bias. The 5 studies evaluated included a total of 91 patients and were noted to have significant heterogeneity in the populations included. For speech perception in noise, there was not consistent improvement with aided hearing over unaided hearing in all environments. All studies reported equal sound localization in the aided and unaided conditions, and quality-of-life measures were similar for the aided and unaided conditions.
 
Lin et al (2006) reported on use of BAHAs in 23 patients with unilateral deafness and noted that speech recognition in noise was significantly better with the BAHA device than with the AC CROS device (Lin, 2006). While the report also commented that benefit was seen in those with moderate sensorineural hearing loss in the contralateral ear (25-50 dB), this conclusion was based on 5 patients. Larger studies are needed to support the use of BAHA for bilateral sensorineural hearing loss.
 
Safety and Adverse Events Related to Bone-Anchored Hearing Aids
 
In addition to the literature evaluating the effectiveness of BAHA devices in improving hearing, a number of studies have evaluated or reported specifically on complications related to BAHAs.
 
In 2013, 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 (Kiringoda, 2013). While the quality of available studies was considered poor and lacking in uniformity, complications related to BAHA implants were mostly minor skin reactions. The incidence of Holgers grade 2 to 4 skin reactions was 2.4% to 38.1% in all studies (grade 2, red and moist tissue; grade 3, granulation tissue; and grade 4, infection leading to removal of the abutment). The incidence of failed osseointegration was 0% to 18% in adult and mixed population studies and 0% to 14.3% in pediatric population studies. The incidence of revision surgery was 1.7% to 34.5% in adult and mixed population studies and 0.0% to 44.4% in pediatric population studies. Implant loss occurred in 1.6% to 17.4% in adult and mixed population studies and in 0.0% to 25% in pediatric studies.
 
In 2014, Allis et al conducted a prospective observational cohort study with a retrospective historical control to evaluate complication rates of skin overgrowth, infection, and the need for revision surgery associated with a BAHA implant with a longer (8.5 mm) abutment (Allis, 2014). Twenty-one subjects were treated with the 8.5 mm abutment implant from 2011 to 2012 and were compared with 23 subjects treated with a 5.5 mm-abutment implant from 2010 to 2011. Groups were generally similar at baseline, with the exception that the 8.5 mm abutment implant patients were older (62 years vs 48 years, p=0.012). Patients in the longer abutment group were less likely to experience infection (10% vs 43%; p=0.02), skin overgrowth (5% vs 41%; p=0.007), and need for revision (10% vs 45%; p=0.012).
 
Also in 2014, Calvo Bodnia et al reported results from a retrospective cohort study of patients implanted with a BAHA implant at a single center from 2004 to 2012, with a focus on implant loss, adverse skin reactions, skin overgrowth, and discomfort leading to device removal (Calvo, 2014). The authors reviewed 185 implantations in 176 patients. Ten patients were younger than 16 years (11 implantations), 117 were between 17 to 64 years (121 implantations), and 49 patients were between 65 and 86 years (53 implantations). Adverse skin reactions occurred in 14% of patients, and spontaneous implant loss occurred in 3.8%, at a mean of 2.5 years. The abutment was removed because of discomfort and/or no benefit in 10% overall.
 
In another retrospective cohort study, Rebol reported skin/soft tissue reactions for 47 patients implanted with BAHA devices (Rebol, 2014). Over 9 years of follow-up, the percentage of patients with skin inflammation of 2 or greater on Holger’s skin inflammation grading system ranged from 6% to 22%. Three patients with grade 4 inflammation required fitting of a longer abutment due to skin thickening.
 
In a large retrospective cohort study of 763 BAHA implants in 571 patients treated at a single institution from 1977 to 2011, Larsson et al (2014) reported on rates of implant loss and removal (Larrson, 2014). A total of 141 implants (18%) were lost over a mean follow-up of 6.6 years, 109 (14%) due to loss of osseointegration and 21 (3%) due to trauma, with 11 elective removals.
 
Different techniques for surgically implanting BAHA devices and specific BAHA designs are under investigation to yield improved safety outcomes. Fontaine et al (2014) compared complication rates after 2 different surgical techniques for BAHA implantation among 32 patients treated from 2004 to 2011 (Fontaine, 2014). Complications requiring surgical revision occurred in 20% of cases who underwent a skin flap implantation method (N=20) and in 38% of cases who underwent a full-thickness skin graft implantation method (N=21; P=0.31). Hultcrantz et al (2014) reported shorter surgical times and fewer cases of numbness and peri-implant infections in 12 patients treated with a non-skin-thinning technique, compared with 24 patients treated with either a flap or dermatome implantation technique (Hultcrantz, 2014). In a comparison of 2 types of BAHA devices, one with a 4.5 mm diameter implant with a rounded 6 mm abutment (N=25) and one with a 3.75 mm diameter implant with a conically-shaped 5.5 mm abutment (N=52), Nelissen et al (2014) reported that implant survival was high for both groups over 3 years of follow-up, although the conically-shaped abutment had greater stability (Nelissen, 2014). Singam et al (2014) reported results of a BAHA implantation technique without soft tissue reduction in conjunction with a longer device abutment in 30 patients (Singam, 2014). While 25 patients had no post-operative complications, 3 developed pain requiring soft tissue reduction.
 
Partially Implantable Magnetic Bone-Conduction Hearing Aids
 
O’Niel et al (2014) reported outcomes for 10 pediatric patients with conductive hearing loss treated with the Otomag Sophono device at a single center (O’Niel, 2014). A total of 14 ears were implanted with no surgical complications. The skin complication rate was 35.7%, including skin breakdown (n=2) and pain and erythema (n=5); negative outcomes resulted in 5 (36%) of 14 ears having significant enough difficulties to discontinue use for a period. The mean aided pure-tone average (PTA) was 20.2 dB hearing level, with a mean functional gain of 39.9 dB hearing level. Patients without skin complications consistently used their devices, with an average daily use of 8 to 10 hours.
 
Centric et al (2014) also reported outcomes for 5 pediatric patients treated with the Otomag Sophono device at a single center (Centric, 2014). Etiologies of hearing loss were heterogeneous and included bilateral moderate or severe conductive hearing loss and unilateral sensorineural hearing loss. The average improvement in PTA was 32 dB hearing level, and the average improvement in speech response threshold was 28 dB hearing level. All patients were responding in the normal to mild hearing loss range in the operated ear after device activation.
 
In a similar study, Marsella et al (2014) reported outcomes for 6 pediatric patients treated with the Otomag Sophono device at a single center (Marcella, 2014).  All subjects had bilateral conductive or mixed hearing loss, and 3 had associated syndromes. Patients ranged in age from 5 to 17 years. Post-operatively, 1patient experienced ulceration of the skin under the magnet, which was successfully treated, and 1patient experienced pain associated with the device leading to discontinuation of device use. The median improvement in PTA was 33 dB hearing level and the median free-field pure tone average (0.5-3 kHz) with the device was 32.5 dB hearing level.
 
Ongoing and Unpublished Clinical Trials
A search of online database, ClinicalTrials.gov, on December 17, 2014, found several ongoing studies on related to bone-conduction hearing implant devices:
 
 
  • Comparison of BAHA and CROS Hearing Aid in Single-Sided Deafness (NCT01715948) – This is a randomized trial of noncomparative interventional study of a unilateral BAHA device with contralateral routing of signals among patients with unilateral deafness. Enrollment is planned for 9 patients; the study completion date is listed as October 2013, but no published results have been identified.
  • Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) (NCT01264510) – This is a nonrandomized, non-interventional phase 4 open-label study will to evaluate the effectiveness of BAHAs for conductive or mixed hearing loss, or unilateral deafness. Enrollment is planned for 150 subjects; the estimated study completion date is August 2015.
  • Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System (NCT02092610) – This is a randomized, open-label trial to compare a novel BAHA implant with standard implants. The study’s primary outcome is implant stability. Enrollment is planned for 77 subjects; the estimated study completion date is January 2015.
 
Several Two studies were identified that will evaluate a partially implantable transcutaneous bone-conduction hearing implant:
  • Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha® Attract System) (NCT02022085) – This is a nonrandomized safety/efficacy study to evaluate the BAHA Attract System in patients with conductive or mixed hearing loss in the ear to be implanted or with single-sided sensorineural deafness. Enrollment is planned for 52 subjects; the estimated study completion date is March 2015, with follow-up through April 2017.
  • Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System) (NCT01822119) – This is a nonrandomized, single-arm study to evaluate the BAHA Attract System in patients with conductive or mixed hearing loss in the ear to be implanted or with single-sided sensorineural deafness. Enrollment is planned for 22 subjects; the estimated study completion date is listed as February 2014, but no published results were identified.
  • A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge (NCT01858246) – This is a randomized, open-label trial to compare a conventional bone-conduction hearing device with a new partially implantable transcutaneous bone-conduction hearing implant (Vibrant Bonebridge™) in patients with conductive hearing loss.
 
The available evidence for partially implantable magnetic bone-conduction hearing systems is preliminary and limited to small, single-center case series. Therefore, conclusions on net health outcomes cannot be made, and partially implantable bone-conduction hearing systems are considered investigational.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Leterme and colleagues assessed 24 adults with SSD, 18 of whom were evaluated with trials of both hearing aids with CROS and bone conduction‒assisted hearing using the Baha Softband (Leterme, 2015). Most (72%) patients, after completing trials of both devices, preferred the BAHA device to hearing aid with CROS. Glasgow Benefit Index and Abbreviated Profile of Hearing Aid Benefit (APHAB) scores did not differ significantly between devices. Sixteen of the 18 subjects elected to undergo implantation of a percutaneous BAHA device. In general, hearing improvement with the Baha Softband trial correlated with hearing improvements following device implantation.
 
The BAHA device has been investigated in children younger than 5 years in Europe. A number of reports have described experience with preschool children or children with developmental issues that might interfere with device maintenance and skin integrity. A 2-stage procedure may be used in young children. In the first stage, the fixture is placed into the bone and allowed to fully osseointegrate. After 3 to 6 months, a second procedure is performed to connect the abutment through the skin to the fixture.
 
The largest series in children under 5 years we identified, described by Amonoo-Kuofi and colleagues (2015), included 24 children identified from a single center’s prospectively maintained database (Amonoo-Kuofi, 2015).  Most patients underwent a 2-stage surgical approach. Most (52%) patients received the implant for isolated microtia or Goldenhar syndrome (16%). Following implantation, 13 (54%) patients had grade 2 or 3 local reactions assessed on the Holgers Scale (redness, moistness, and/or granulation tissue) and 7 (29%) had grade 4 local reactions on the Holgers Scale (extensive soft-tissue reaction requiring removal of the abutment). Quality of life scores (Glasgow Children’s Benefit Inventory; scoring range, -100 to 100) were obtained in 18 subjects/parents, with a finale mean score change of +40 points. Audiologic testing indicated that the average performance of the device fell within the range of normal auditory perception in noisy and quiet environments.
 
Safety and Adverse Events Related to BAHA Devices
Different surgical techniques for implanting BAHA devices and specific BAHA designs have yielded better safety outcomes. In a systematic review of the association between surgical technique and skin complications following BAHA implantation, which included 30 articles, the dermatome technique (vs a skin graft or linear technique) was linked to more frequent skin complications (Mohamad, 2016).
 
Prospective Clinical Trials
Briggs and colleagues reported on a prospective interventional evaluation of the percutaneous, partially implantable Baha Attract System among 27 adults with a CHL or mild mixed hearing loss in the ear to be implanted (Briggs, 2015). The choice of sound processor was based on patient preference and hearing tests with various sound processors in conjunction with a Baha Softband prior to device implantation. All 27 patients enrolled received an implant. Sound processor fitting occurred 4 weeks postimplantation in all but 1 patient. At 9-month follow-up, pure-tone audiometry (mean of 500, 1000, 2000, and 4000 Hz) was significantly improved with the implant and sound processor compared with unaided hearing (18.4-dB hearing loss; SD=6.9 dB; p<0.001). Patients generally showed improvements in speech recognition in noise, although comparing results across test sites was difficult due to different languages and methodologies used for testing speech recognition at each site. Compared with the preoperative unaided state, scores on the APHAB overall score (p=0.038) and reverberation (p=0.016) and background noise (p=0.035) subscales.
 
Denoyelle and colleagues reported on a prospective trial of the Sophono device in children ages 5 to 18 years with uni- or bilateral congenital aural atresia with complete absence of the external auditory canal with pure CHL (Denoyelle, 2015). The study included a within-subject comparison of hearing results with the Sophono devices to those obtained with the Baha Softband preoperatively. All 15 patients enrolled were implanted (median age, 97 months). At 6-month follow-up, mean aided AC pure-tone audiometry was 33.49 (mean gain, 35.53 dB), with a mean aided sound reception threshold of 38.2 (mean gain, 33.47 dB). The difference in AC PTA between the Baha Softband and the Sophono device was 0.6 dB (confidence interval upper limit, 4.42 dB), which met the study’s prespecified noninferiority margin. Adverse effects were generally mild, including skin erythema in 2 patients, which improved by using a weaker magnet, and brief episodes of pain or tingling in 3 patients.
 
Nonrandomized Comparative Studies
A limited amount of data is available comparing transcutaneous to percutaneous bone-anchored conduction devices. In 2013, Hol and colleagues compared percutaneous BAHA implants to partially implantable magnetic transcutaneous bone-conduction hearing implants using the Otomag Sophono device in 12 pediatric patients (age range, 5-12 years), who had congenital unilateral CHL (Hol, 2013). Sound-field thresholds, speech recognition threshold, and speech comprehension at 65 dB were somewhat better in patients with the BAHA implant (n=6) than those with the partially implantable hearing device (n=6). Using a skull simulator, output was 10 to 15 dB less with the partially implantable device than with the BAHA device.
 
Iseri and colleagues described a retrospective, single-center study from Turkey comparing 21 patients treated with a transcutaneous, fully implantable BAHA to 16 patients treated with a percutaneous device (the Baha Attract) (Sieri, 2015). Groups were generally similar at baseline, with most individuals undergoing BAHA placement for chronic otitis media. Operating time was longer in patients treated with the transcutaneous partially implantable devices (46 minutes vs 26 minutes, p<0.05). Three patients treated with percutaneous devices had Holger grade 2 skin reactions and 2 had stopped using their devices for reasons unrelated to skin reactions. Mean thresholds for frequencies 0.5 to 4.0 kHz were 64.4 dB without the BAHA and 31.6 dB with the BAHA in the percutaneous device group, and 58.3 dB without the BAHA and 27.2 dB with the BAHA in the transcutaneous device group. Frequency-specific threshold hearing gains did not differ significantly between groups. Mean hearing gain measured by speech reception threshold was statistically significantly smaller in the percutaneous group (24 dB vs 36.7 dB, p=0.02).
 
Observational Studies
Powell and colleagues reported outcomes from a retrospective study that included 6 patients treated with the Otomag Sophono device and 6 treated with the BAHA Attract device (Powell, 2015). Ten subjects were identified as the primary author’s patients and the remaining were identified through an Australian national hearing database. In the BAHA Attract group, mean AC thresholds across 4 frequencies (0.5, 1, 2, and 4 kHz) improved from 60.8 dB in the unaided state to 30.6 dB in the aided state. In the Sophono group, the mean 4-frequency AC thresholds improved from 57.8 dB in the unaided state to 29.8 dB in the aided state. Speech discrimination in noise scores did not differ significantly between devices.
 
Baker and colleagues reported pooled outcomes for the first 11 patients treated with the Otomag Sophono and the first 6 patients treated with the Baha Attract (Baker, 2015).  Pre- and postimplant audiometric data were available for 11 ears in the Sophono group and 5 in the Baha Attract group. Average improvement over all frequencies ranged from a 24- to 43-dB hearing level in the Sophono group and a 32- to 45-dB hearing level in the Baha Attract group. Average improvement in PTA was a 38-dB hearing level in the Sophono group and a 41-dB hearing level in the Baha Attract group.
 
Additional single-center observational series have described clinical experience with transcutaneous partially implantable BAHA devices. Marsella and colleagues reported outcomes for 6 pediatric patients treated with the Otomag Sophono device for CHL or mixed hearing loss (Marsella, 2014).  Median improvement in PTA was 33 dB HL and median free-field PTA (0.5-3 kHz) with the device was 32.5 dB HL.
 
Carr and colleagues reported outcomes for 10 patients treated with the Baha Attract device, most commonly for chronic suppurative otitis media (n=3) and SSD (n=3) (Carr, 2015). Patients did not show significant improvement in word discrimination score.
 
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Snapp and colleagues reported a prospective single-center study of 27 patients with unilateral severe-profound sensorineural hearing loss who had either a CROS (n=13) or transcutaneous BAHA (n=14) device (Snapp, 2017). Mean device use was 66 months for the BAHAs and 34 months for CROS devices. Both BAHA and CROS groups had significant improvement in speech-in-noise performance, but neither showed improvement in localization ability. There were no differences between the devices for subjective measures of posttreatment residual disability or satisfaction as measured by the Glasgow Hearing Aid Benefit Profile (GHABP).
 
Verheijand colleagues published a systematic review on complications of tissue preservation surgical techniques with percutaneous BAHA devices including 18 studies with 381 devices (Verheijand, 2016). The implantation techniques reported in the studies were as follows: punch method, 4 studies (81 implants); linear incision technique without soft tissue reduction, 13 studies (288 implants); and Weber technique, 1 study (12 implants). Indications for surgery were SSD (n=68), sensorineural hearing loss (n=4), mixed hearing loss (n=65), or CHL (n=66). The Holgers classification was used to grade soft tissue reactions (grade 0, no reaction; grade 2, red and moist tissue; grade 3, granulation tissue; grade 4, removal of skin-penetrating implant necessary due to infection). The incidence of Holgers 3 was 2.5% with the punch technique, 5.9% with the linear incision technique, and 0% with the Weber technique. Holgers 4 was reported in 1 patient implanted with the linear incision technique.
 
Roplekar and colleagues compared skin-related complications of the traditional skin flap method to the linear incision method performed by a single surgeon in 117 patients with at least 1 year of follow-up (Roplekar, 2016). Twenty-one (24%) patients experienced skin-related complications in the skin flap group (12 skin overgrowths, 8 wound infections, 1 numbness) and 3 (10%) patients experienced complications in the linear incision group (3 wound infections).
 
Gerdes  and colleagues published a retrospective single-center study comparing 10 patients with CHL implanted with the transcutaneous Bonebridge device to an audiologically matched control group of 10 patients with the percutaneous BAHA BP100 (Gerdes, 2016). There were similar significant improvements in aided thresholds, word recognition scores, and speech reception thresholds in noise for both devices. There were also no differences in subjective ratings for the APHAB scale. Mean functional gain was slightly higher (27.5 dB) for transcutaneous than for percutaneous (26.3 dB), but not significantly different.
 
Dimitriadis and colleagues reported a systematic review of observational studies of the BAHA Attract device including 10 studies (total N=89 patients; range, 1-27 patients) (Dimitriadis, 2016). Seventeen (19%) of the patients were children, of whom 5 had unilateral sensorineural hearing loss and 4 had CHL. Of the 27 (45%) adults, 22 had unilateral sensorineural hearing loss and 11 (18%) had bilateral mixed hearing loss. Audiologic and functional outcome measures and the timing of testing varied greatly in the studies. Summary measures were not reported. In general, audiologic and functional outcomes measured pre- and postimplantation showed improvement, although statistical comparisons were lacking in some studies.
 
Reddy-Kolanu and colleagues reported on complications of the BAHA Attract (n=34) from a case series included all patients implanted in a single center between October 2013 and April 2015 (Reddy-Kolanu, 2016). Patients ranged in age from 8 to 64 years, and follow-up ranged from 3 to 20 months. Twenty-three patients had no significant postoperative problems. Five patients required an alteration in magnet strength primarily due to implant site tenderness. One patient reported distressing tinnitus; 1 had the implant changed to an abutment system due to infection; and 1 had the magnet removed following trauma to the implant site. One patient has ongoing psoriasis problems. Two patients were converted to a newer, lighter sound processor.
 
Schmerber and colleagues published a case series evaluating the Bonebridge implant (Schmerber, 2016). The patient population included 12 single sided deafness (SSD), 7 bilateral conductive hearing loss (CHL), 6 bilateral mixed hearing loss (HL). The main hearing results were SSD, in 5/7 patients speech reception threshold in noise lower with Bonebridge activated. CHL and mixed, average functional gain: 26 dB HL; mean % of speech recognition in quiet improved from 74% unaided to 95% aided. In safety outcomes there were no complications, device failures, revision surgery or skin injury reported with 1 year follow-up.
 
Ongoing and Unpublished Clinical Trials
A search of online database, ClinicalTrials.gov, on March, 2017, did not find any new studies on related to bone-conduction hearing implant devices
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.   
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Since the publication of the Peters systematic review, three prospective, interventional studies have compared patient outcomes using transcutaneous BAHA devices with CROS hearing aids for SSD. den Besten et al assessed 54 adults with SSD, each of whom underwent a trial with the Baha Softband before a trial of the percutaneous, partially implantable Baha Attract device (den Besten, 2018). No statistically significant difference in audiological outcomes was seen between the two devices (p > 0.05). At a 6 month follow-up after implantation, patients reported numbness (20%) and slight pain/discomfort (38%) associated with the device. Leterme et al assessed 24 adults with SSD, 18 of whom were evaluated with trials of both hearing aids with CROS and bone-conduction‒assisted hearing using the Baha Softband (Leterme, 2015). Most (72%) patients, after completing trials of both devices, preferred the BAHA device to hearing aids with CROS. Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit scores did not differ significantly between devices. Sixteen of the 18 subjects elected to undergo implantation of a percutaneous BAHA device. In general, hearing improvement with the Baha Softband trial correlated with hearing improvements following device implantation. Snapp et al reported on a prospective single-center study of 27 patients with unilateral severe-profound sensorineural hearing loss who had either a CROS (n=13) or transcutaneous BAHA (n=14) device (Snapp, 2017). Mean device use was 66 months for the BAHAs and 34 months for CROS devices. Both BAHA and CROS groups had significant improvement in speech-in-noise performance, but neither showed improvement in localization ability. There were no differences between the devices for subjective measures of posttreatment residual disability or satisfaction as measured by the Glasgow Hearing Aid Benefit Profile.
 
2020 Update
A literature search was conducted through June 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Schwab et al. completed a systematic review of adverse events associated with bone-conduction and middle-ear implants (Schwab, 2020). The 10 most frequently reported adverse events for bone conduction hearing implants included skin reactions (Holgers grade 1 to 3), skin revision surgery due to overgrowth or cellulitis, minor soft tissue/skin overgrowth, skin infection, surgical revision, preimplantation, failure to osseointegrate, and minor skin complications.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
69710Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone
69711Removal or repair of electromagnetic bone conduction hearing device in temporal bone
69714Implantation, osseointegrated implant, skull, with percutaneous attachment to external speech processor
69715Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; with mastoidectomy
69716Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or resulting in removal of less than 100 sq mm surface area of bone deep to the outer cranial cortex
69717Replacement (including removal of existing device), osseointegrated implant, with percutaneous attachment to external speech processor.
69718Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; with mastoidectomy
69719Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor
69726Removal, entire osseointegrated implant, skull; with percutaneous attachment to external speech processor
69727Removal, entire osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor
L8625External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each
L8690Auditory osseointegrated device, includes all internal and external components
L8691Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each
L8693Auditory osseointegrated device abutment, any length, replacement only
L8694Auditory osseointegrated device, transducer/actuator, replacement only, each

References: Allis TJ, Owen BD, Chen B, et al.(2014) Longer length Baha abutments decrease wound complications and revision surgery. Laryngoscope. Apr 2014;124(4):989-992. PMID 24114744

American Academy of Otolaryngology-Head and Neck Surgery.(2016) Position Statement: Bone Conduction Hearing Devices. Position Statements 2016; http://www.entnet.org/content/position-statement-bone-conduction-hearing-devices.

Amonoo-Kuofi K, Kelly A, Neeff M, et al.(2015) Experience of bone-anchored hearing aid implantation in children younger than 5 years of age. Int J Pediatr Otorhinolaryngol. Apr 2015;79(4):474-480. PMID 25680294

Andersen HT, Schroder SA, Bonding P.(2006) Unilateral deafness after acoustin neuroma surgery: subjective hearing handicap and the effect of the bone-anchored hearing aid. Oto Neurotol, 2006; 27:809-14.

Baguley DM, Bird J, et al.(2006) The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol, 2006; 31:6-14.

Baker S, Centric A, Chennupati SK(2015) Innovation in abutment-free bone-anchored hearing devices in children: Updated results and experience. Int J Pediatr Otorhinolaryngol. Oct 2015;79(10):1667-1672. PMID 26279245

Bosman AJ, Snik AF, vander Pouw CT et al.(2001) Audiometric evaluation of bilaterally fitted bone-anchored hearing aids. Audiology 2001; 40:158-67.

Bravo-Torres S, Der-Mussa C, Fuentes-Lopez E.(2018) Active transcutaneous bone conduction implant: audiological results in paediatric patients with bilateral microtia associated with external auditory canal atresia. Int J Audiol. Jan 2018;57(1):53-60. PMID 28857620

Briggs R, Van Hasselt A, Luntz M, et al.(2015) Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. Jun 2015;36(5):834-841. PMID 25634465

Calvo Bodnia N, Foghsgaard S, Nue Moller M, et al.(2014) Long-term Results of 185 Consecutive Osseointegrated Hearing Device Implantations: A Comparison Among Children, Adults, and Elderly. Otol Neurotol. Dec 2014;35(10):e301-306. PMID 25122598

Carr SD, Moraleda J, Procter V, et al.(2015) Initial UK Experience With a Novel Magnetic Transcutaneous Bone Conduction Device. Otol Neurotol. Sep 2015;36(8):1399-1402. PMID 26196208

Davids T, Gordon KA, Clutton D et al.(2007) Bone-anchored hearing aids in infants and children younger than 5 years. Arch Otolaryngol Head Neck Surg 2007; 133(1):51-5.

den Besten CA, Harterink E, McDermott AL, et al.(2015) Clinical results of Cochlear BIA300 in children: Experience in two tertiary referral centers. Int J Pediatr Otorhinolaryngol. Dec 2015;79(12):2050-2055. PMID 26455259

den Besten CA, Monksfield P, Bosman A, et al.(2018) Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study. Clin Otolaryngol. Oct 25 2018. PMID 30358920

Denoyelle F, Coudert C, Thierry B, et al.(2015) Hearing rehabilitation with the closed skin bone-anchored implant Sophono Alpha1: results of a prospective study in 15 children with ear atresia. Int J Pediatr Otorhinolaryngol. Mar 2015;79(3):382-387. PMID 25617189

Desmet J, Wouters K, De Bodt M, et al.(2014) Long-term subjective benefit with a bone conduction implant sound processor in 44 patients with single-sided deafness. Otol Neurotol. Jul 2014;35(6):1017-1025. PMID 24751733

Dimitriadis PA, Farr MR, Allam A, et al.(2016) Three year experience with the cochlear BAHA attract implant: a systematic review of the literature. BMC Ear Nose Throat Disord. 2016;16:12. PMID 27733813

Dun CA, de Wolf MJ, Mylanus EA et al.(2010) Bilateral bone-anchored hearing aid application in children: the Nijmegen experience from 1996 to 2008. Otol Neurotol 2010; 31(4):615-23.

Farnoosh S, Mitsinikos FT, Maceri D, et al.(2014) Bone-Anchored Hearing Aid vs. Reconstruction of the External Auditory Canal in Children and Adolescents with Congenital Aural Atresia: A Comparison Study of Outcomes. Front Pediatr. 2014;2:5. PMID 24479110

Fontaine N, Hemar P, Schultz P, et al.(2014) BAHA implant: implantation technique and complications. Eur Ann Otorhinolaryngol Head Neck Dis. Feb 2014;131(1):69-74. PMID 23835074

Gerdes T, Salcher RB, Schwab B, et al.(2016) Comparison of audiological results between a transcutaneous and a percutaneous bone conduction instrument in conductive hearing loss. Otol Neurotol. Jul 2016;37(6):685-691. PMID 27093021

Granstrom G, Tjellstrom A.(1995) The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J;76(4):238-47; 1997.

Granstrom G, Tjellstrom A.(1997) The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J 1997; 76(4):238-47.

Hill-Feltham P, Roberts SA, Gladdis R.(2014) Digital processing technology for bone-anchored hearing aids: randomised comparison of two devices in hearing aid users with mixed or conductive hearing loss. J Laryngol Otol. Feb 2014;128(2):119-127. PMID 24524414

Ho EC, Monksfield P, Egan E et al.(2009) Bilateral Bone-anchored Hearing Aid: impact on quality of life measured with the Glasgow Benefit Inventory. Otol Neurotol 2009; 30(7):891-6.

Hobson JC, Roper AJ, Andrew R et al.(2010) Complications of bone-anchored hearing aid implantation. J Laryngol Otol 2010; 124(2):132-6.

Hol MK, Nelissen RC, Agterberg MJ et al.(2013) Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol 2013; 34(6):1071-5.

Hol MK, Nelissen RC, Agterberg MJ, et al.(2013) Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol. Aug 2013;34(6):1071-1075. PMID 23598702

House JW, Kutz JW.(2007) Bone-anchored hearing aid: incidence and management of postoperative complications. Otol Neurotol, 2007; 28:213-7.

Hultcrantz M, Lanis A.(2014) A five-year follow-up on the osseointegration of bone-anchored hearing device implantation without tissue reduction. Otol Neurotol. Sep 2014;35(8):1480-1485. PMID 24770406

Ihler F, Volbers L, Blum J, et al.(2014) Preliminary functional results and quality of life after implantation of a new bone conduction hearing device in patients with conductive and mixed hearing loss. Otol Neurotol. Feb 2014;35(2):211-215. PMID 24448279

Iseri M, Orhan KS, Kara A, et al.(2014) A new transcutaneous bone anchored hearing device - the Baha(R) Attract System: the first experience in Turkey. Kulak Burun Bogaz Ihtis Derg. Mar-Apr 2014;24(2):59-64. PMID 24835899

Iseri M, Orhan KS, Tuncer U, et al.(2015) Transcutaneous bone-anchored hearing aids versus percutaneous ones: multicenter comparative clinical study. Otol Neurotol. Jun 2015;36(5):849-853. PMID 25730451

Kiringoda R, Lustig LR.(2013) A meta-analysis of the complications associated with osseointegrated hearing aids. Otol Neurotol 2013; 34(5):790-4.

Kompis M, Kurz A, Pfiffner F, et al.(2014) Is complex signal processing for bone conduction hearing aids useful? Cochlear Implants Int. May 2014;15 Suppl 1:S47-50. PMID 24869443

Kraai T, Brown C, Neeff M, et al.(2011) Complications of bone-anchored hearing aids in pediatric patients. Int J Pediatr Otorhinolaryngol. Jun 2011;75(6):749-753. PMID 21470698

Kunst SJ, Leijendeckers JM, Mylanus EA et al.(2008) Bone-anchored hearing aid system application for unilateral congenital conductive hearing impairment: audiometic results. Otol Neurotol 2008; 29(1):2-7.

Kunst SJ, Leijendeckers JM, Mylanus EA et al.(2008) Subjective benefit after BAHA system application in patients with congenital unilateral conductive hearing impairment. Otol Neurotol 2008; 29(3):353-58.

Larsson A, Tjellstrom A, Stalfors J.(2014) Implant Losses for the Bone-Anchored Hearing Devices Are More Frequent in Some Patients. Otol Neurotol. May 7 2014. PMID 24809279

Leterme G, Bernardeschi D, Bensemman A, et al.(2015) Contralateral routing of signal hearing aid versus transcutaneous bone conduction in single-sided deafness. Audiol Neurootol. 2015;20(4):251-260. PMID 26021779

Lin LM, Bowditch S, et al.(2006) 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 Neurol, 2006; 27:172-82.

Manrique M, Sanhueza I, Manrique R, et al.(2014) A new bone conduction implant: surgical technique and results. Otol Neurotol. Feb 2014;35(2):216-220. PMID 24448280

Marsella P, Scorpecci A, Vallarino MV, et al.(2014) Sophono in pediatric patients: the experience of an Italian tertiary care center. Otolaryngol Head Neck Surg. Apr 8 2014;151(2):328-332. PMID 24714216

McDermott AL, Williams J, Kuo MJ.(2008) The role of bone anchored hearing aids in children with Down syndrome. Int J Pediatr Otorhinolaryngol 2008; 72(6):751-7.

McLarnon CM, Davison T, Johnson IJ.(2004) Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope, 2004; 114:942-4.

Mohamad S, Khan I, Hey SY, et al.(2016) A systematic review on skin complications of bone-anchored hearing aids in relation to surgical techniques. Eur Arch Otorhinolaryngol. Mar 2016;273(3):559-565. PMID 25503356

Nelissen RC, Stalfors J, de Wolf MJ, et al.(2014) Long-term stability, survival, and tolerability of a novel osseointegrated implant for bone conduction hearing: 3-year data from a multicenter, randomized, controlled, clinical investigation. Otol Neurotol. Sep 2014;35(8):1486-1491. PMID 25080037

O'Niel MB, Runge CL, Friedland DR, et al.(2014) Patient Outcomes in Magnet-Based Implantable Auditory Assist Devices. JAMA Otolaryngol Head Neck Surg. Apr 24 2014. PMID 24763485

Peters JP, Smit AL, Stegeman I, et al.(2014) Review: Bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. Aug 14 2014. PMID 25124297

Powell HR, Rolfe AM, Birman CS.(2015) A comparative study of audiologic outcomes for two transcutaneous bone-anchored hearing devices. Otol Neurotol. Sep 2015;36(9):1525-1531. PMID 26375976

Priwin C, Stenfelt S, Granstrom G et al.(2004) Bilateral bone-anchored hearing aids (BAHAs): an audiometric evaluation. Laryngoscope 2004; 114:77-84.

Ramakrishnan Y, Marley S, Leese D et al.(2010) Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. J Laryngol Otol 2010:1-5.

Rebol J.(2014) Soft tissue reactions in patients with bone anchored hearing aids. Ir J Med Sci. Jun 10 2014. PMID 24913737

Reddy-Kolanu R, Gan R, Marshall AH.(2016) A case series of a magnetic bone conduction hearing implant. Ann R Coll Surg Engl. Nov 2016;98(8):552-553. PMID 27490984

Roplekar R, Lim A, Hussain SS.(2016) Has the use of the linear incision reduced skin complications in bone-anchored hearing aid implantation? J Laryngol Otol. Jun 2016;130(6):541-544. PMID 27160014

Schmerber S, Deguine O, Marx M, et al.(2016) Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. Jul 30 2016. PMID 27475796

Schwab B, Wimmer W, Severens JL, et al.(2020) Adverse events associated with bone-conduction and middle-ear implants: a systematic review. Eur Arch Otorhinolaryngol. Feb 2020; 277(2): 423-438. PMID 31749056

Snapp HA, Holt FD, Liu X, et al.(2017) Comparison of speech-in-noise and localization benefits in unilateral hearing loss subjects using contralateral routing of signal hearing aids or bone-anchored implants. Otol Neurotol. Jan 2017;38(1):11-18. PMID 27846038

Snik AF, Bosman AJ, et al.(2004) Candidacy for the bone-anchored hearing aid. Audiol Neurotol, 2004; 9:190-6.

Snik AF, Mylanus EA, Cremers CW.(1995) 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.

Snik AF, Mylanus EA, Cremers CW.(2002) The bone-anchored hearing aid in patients with a unilateral air-bone gap. Otology and Neurotology, 202; 23:61-66.

Snik AF, Mylanus EA, et al.(2005) Consensus statements on the BAHA system: where do we stand at present. Ann Otol Rhinol Laryngol Suppl, 2005; 195:2-12.

Snik AF, Mylanus EA, Proops DW et al.(2005) Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl 2005; 195:2-12.

Spitzer JB, Ghossaini SN, Wazen JJ.(2002) Evolving applications in the use of bone-anchored hearing aids. American J of Audiology, 2002; 11:96-103.

Tjellstrom A, Granstrom G, Odersjo M.(2006) Survival rate of self-tapping implants for bone-anchored hearing aids. J Laryngol Otol, 2006; 1-4 [Epub ahead of print].

Tringali S, Grayeli AB, Bouccara D et al.(2008) A survey of satisfaction and use among patients fitted with a BAHA. Eur Arch Otorhinolaryngol 2008; 265(12):1461-4.

van der Pouw CT, Snik AF, Cremers CW.(1999) The BAHA HC200/300 in comparison with conventional bone conduction hearing aids. Clin Otolaryngol 1999; 24(3):171-6.

Verheij E, Bezdjian A, Grolman W, et al.(2016) A systematic review on complications of tissue preservation surgical techniques in percutaneous bone conduction hearing devices. Otol Neurotol. Aug 2016;37(7):829-837. PMID 27273402

Wazen JJ, Caruso M, Tjellstrom A.(1998) Long-term results with titanium bone anchored hearing aid: the U.S. experience. Am J Otol 1998;19(6):737-41.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2023 American Medical Association.