Blue Cross of Idaho Logo

Express Sign-on

Thank you for registering with Blue Cross of Idaho

If you are an Individual or Family Member, please register here.

If you are a Medicare Advantage or Medicare Supplement member, please register here.

New Options for Affordable Health Insurance

 

MP 7.01.03 Implantable Bone-Conduction and Bone-Anchored Hearing Aids

Medical Policy    
Section
Surgery 
Original Policy Date
12/1/95
Last Review Status/Date
Reviewed with literature search/1:2014
Issue
1:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


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. 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.

Background

Hearing loss is described as conductive, sensorineural, or mixed and can be unilateral or bilateral. Normal hearing is the detection of sound at or below 20 dB (decibel). The American Speech-Language-Hearing Association (ASLHA) has defined the degree of hearing loss based on pure-tone average (PTA) detection thresholds as mild (20-40 dB), moderate (40-60 dB), severe (60-80 dB), and profound (≥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 AC 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 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 the process of osseointegration through which living tissue integrates with titanium in the implant over a period of 3 to 6 months, 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-conduction hearing aids.

Partially implantable magnetic bone-conduction hearing systems are available as an alternative to bone- conduction hearing systems connected 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 a 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 may be reduced to 4 to 5 mm over the implant when it is surgically placed.

Regulatory Status

There are 5 BAHA® sound processors for use with the BAHA auditory osseointegrated implant system manufactured by Cochlear Americas (Englewood, CO) that have received 510(k) clearance from the U.S. Food and Drug Administration (FDA):

  • BAHA Cordelle II
  • BAHA Divino
  • BAHA Intenso (digital signal processing)
  • BAHA BP100
  • BAHA 4 (upgraded from the BP100)

FDA cleared the BAHA system for the following indications:

  • Patients who have conductive or mixed hearing loss and can still benefit from sound amplification;
  • Patients with bilaterally symmetric conductive or mixed hearing loss, may be implanted bilaterally;
  • Patients with sensorineural deafness in 1 ear and normal hearing in the other (ie, single-sided deafness, SSD);
  • Patients who are candidates for an air-conduction contralateral routing of signals (AC CROS) hearing aid but who cannot or will not wear an AC CROS device.

The BAHA implant is cleared for use in children aged 5 years and older, and in adults.

BAHA sound processors can also be used with the BAHA® Softband™. With this application, there is no implantation surgery. The sound processor is attached to the head using either a hard or soft headband. The amplified sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The BAHA® Softband™ received FDA clearance in 2002 for use in children younger than the age of 5 years. As this application has no implanted components, it is not addressed in the policy.

In November 2008, the device “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 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 (eg, the Xomed Audiant™, which was FDA cleared for marketing in 1986 but is no longer available). They share similar indications as the Cochlear Americas BAHA devices.

The 2 partially implantable magnetic bone-conduction devices that have received 510(k) clearance from FDA are:

  • Otomag Bone Conduction Hearing System, and
  • BAHA Attract. 

Policy 

Unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in patients 5 years of age and older with a conductive or mixed hearing loss who also meet at least one of the following medical criteria:

  • Congenital or surgically induced malformations (eg, 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 (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction CROS hearing aid in patients 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. 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 implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered investigational.

Partially implantable magnetic bone-conduction hearing systems using magnetic coupling for acoustic transmission (eg, Otomag Alpha 1 and BAHA Attract) are considered investigational.


Policy Guidelines 

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.

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.

69714: Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy**

69715: as above, but with mastoidectomy**

** The above 2 CPT codes describe the BAHA device.

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


Benefit Application
BlueCard/National Account Issues 

These devices are referred to as Hearing Aid, Bone Conduction in the U.S. Food and Drug Administration (FDA) approval. The FDA review also indicates that this device has substantially equivalent technology as air-conduction hearing aids with digital sound processing. However, beginning December 2005, the Centers for Medicare and Medicaid Services (CMS) began to consider these devices as prosthetics. Thus, Plans need to review contract language in making decisions about classification.

Benefit limitations regarding hearing aids may apply to these devices. Many medical insurance plans do not provide coverage for hearing aids or provide limited coverage.

State or federal mandates (e.g., FEP) may dictate that all devices approved by the FDA may not be considered investigational. However, this policy considers specific applications of an FDA-approved device as investigational. Alternatively, FDA-approved devices may be assessed on the basis of their medical necessity.


Rationale

 

Literature Review

This policy was created in 1995 and updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period December 7, 2012, through December 13, 2013. 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- and posthearing 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-Analyses

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

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

Observational Studies

In 2010, Ramakrishnan et al 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 comorbidity. 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, 11-72). 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 heterogeneous patient population, a lack of preintervention measures, or a controlled comparator group.

In 2004, McLarnon et al 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 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 (SSD) (2 after surgery for meningioma, idiopathic sudden deafness, 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 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 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 intrasubject. 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 to 15 dB, the improvement in speech recognition patterns ranged from 4 to 5.4 dB, and the improvement in the Word Recognition Score ranged from 1% to 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 et al 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 et al 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 CHL and symmetric bone-conduction thresholds.(14) 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 et al(15) identified improvements in the Glasgow Benefit Inventory in children (n=23), while Ho et al(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 (SSD). Most of these studies have been retrospective. In 1 prospective study conducted within a hospital auditory implant center in the United Kingdom, Pai et al reported significant improvement in the average score in all 3 sections (speech hearing, spatial hearing, other qualities) of the Speech, Spatial and Qualities of hearing scale 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 SSD with residual hearing in the implanted ear within a university medical center in the U.S.(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 et al 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 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 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 5 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 et al. In 1 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, nonsignificant 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.(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 Younger Than Age 5 Years

A 2008 review article notes that for children younger than age 5 years, other solutions (such as a bone conductor with transcutaneous coupling) should be utilized.(24) This recommendation is in agreement with 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 may be used in young children. In the first stage, the fixture is placed into the bone and allowed to fully develop osseointegration. After 3 to 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; 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.(25) The conclusions are limited by the small number of children younger 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 younger than 5 years of age for auditory and speech-language development and retrospectively compared surgical outcomes for a study group of 20 children younger than 5 years 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 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 the time of writing. McDermott et al reported on the role of BAHAs 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 a follow-up of 14 months. No fixtures were lost; skin problems were encountered in 3 patients. All 15 patients had improved social and physical functioning, attributed to improved hearing.

Adverse Events

In 2012, Dun et al assessed soft tissue reactions and implant stability of 1132 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, 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).(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 transcutaneous 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 a percutaneous 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.

Ongoing Clinical Trials

A search of online site ClinicalTrials.gov on December 16, 2013, found several ongoing studies on bone-conduction hearing implant devices. A randomized trial of 10 patients will compare a BAHA device to a CROS hearing aid but is not yet recruiting patients. (NCT01715948) 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. An osseointegrated bone-conduction device will be compared to a removable oral bone-conduction appliance in 15 patients in NCT01933386. A Phase IV open study will evaluate the effectiveness of BAHAs for conductive or mixed hearing loss, or unilateral deafness. (NCT01264510) The status of this study is ongoing, but the study is not recruiting participants. Expected enrollment for this study is 150 patients, with an estimated initial completion date of August 2013.

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).

Summary

Bone-conduction hearing aids function by transmitting sound waves through the bone to the ossicles of the middle ear. The available evidence for unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid(s) consists of observational studies that report pre-post differences in hearing parameters after treatment with BAHA. While this evidence is not ideal, 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 and therefore, these devices may be considered medically necessary in these situations. Given the lack of both high-quality evidence and FDA approval, other uses of bone-conduction (bone-anchored) hearing aids, including use in children younger than 5 years and patients with bilateral sensorineural hearing loss, is considered investigational.

The available evidence for partially implantable magnetic 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. The Medicare Benefit Policy Manual(34) references hearing aids and auditory implants, stating that hearing aids are excluded from coverage, including air-conduction and bone-conduction devices. However, devices which produce the perception of sound by replacing the function of the middle ear, cochlea, or auditory nerve are payable by Medicare as prosthetic devices. These devices are indicated only when hearing aids are medically inappropriate or cannot be utilized. Along with cochlear and auditory brainstem implants, the benefit manual specifically refers to osseointegrated implants as prosthetic devices.

References:

  1. Colquitt JL, Loveman E, Baguley DM et al. Bone-anchored hearing aids for people with bilateral hearing impairment: a systematic review. Clin Otolaryngol 2011; 36(5):419-41.
  2. Colquitt JL, Jones J, Harris P et al. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technol Assess 2011; 15(26):1-200, iii-iv.
  3. Kiringoda R, Lustig LR. A meta-analysis of the complications associated with osseointegrated hearing aids. Otol Neurotol 2013; 34(5):790-4.
  4. Ramakrishnan Y, Marley S, Leese D et al. Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. J Laryngol Otol 2011; 125(2):153-7.
  5. McLarnon CM, Davison T, Johnson IJ. Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope 2004; 114(5):942-4.
  6. Tringali S, Grayeli AB, Bouccara D et al. A survey of satisfaction and use among patients fitted with a BAHA. Eur Arch Otorhinolaryngol 2008; 265(12):1461-4.
  7. Snik AF, Mylanus EA, Cremers CW. The bone-anchored hearing aid compared with conventional hearing aids. Audiologic results and the patients' opinions. Otolaryngol Clin North Am 1995; 28(1):73-83.
  8. Wazen JJ, Caruso M, Tjellstrom A. Long-term results with the titanium bone-anchored hearing aid: the U.S. experience. Am J Otol 1998; 19(6):737-41.
  9. van der Pouw CT, Snik AF, Cremers CW. The BAHA HC200/300 in comparison with conventional bone conduction hearing aids. Clin Otolaryngol Allied Sci 1999; 24(3):171-6.
  10. Granstrom G, Tjellstrom A. The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J 1997; 76(4):238-40, 42, 44-7.
  11. Janssen RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing loss: a systematic review. Otolaryngol Head Neck Surg 2012; 147(3):412-22.
  12. Bosman AJ, Snik AF, van der Pouw CT et al. Audiometric evaluation of bilaterally fitted bone-anchored hearing aids. Audiology 2001; 40(3):158-67.
  13. Priwin C, Stenfelt S, Granstrom G et al. Bilateral bone-anchored hearing aids (BAHAs): an audiometric evaluation. Laryngoscope 2004; 114(1):77-84.
  14. Snik AF, Mylanus EA, Proops DW et al. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl 2005; 195:2-12.
  15. Dun CA, de Wolf MJ, Mylanus EA et al. Bilateral bone-anchored hearing aid application in children: the Nijmegen experience from 1996 to 2008. Otol Neurotol 2010; 31(4):615-23.
  16. Ho EC, Monksfield P, Egan E et al. Bilateral Bone-anchored Hearing Aid: impact on quality of life measured with the Glasgow Benefit Inventory. Otol Neurotol 2009; 30(7):891-6.
  17. Pai I, Kelleher C, Nunn T et al. Outcome of bone-anchored hearing aids for single-sided deafness: a prospective study. Acta Otolaryngol 2012; 132(7):751-5.
  18. Zeitler DM, Snapp HA, Telischi FF et al. Bone-anchored implantation for single-sided deafness in patients with less than profound hearing loss. Otolaryngol Head Neck Surg 2012; 147(1):105-11.
  19. Nicolas S, Mohamed A, Yoann P et al. Long-term benefit and sound localization in patients with single-sided deafness rehabilitated with an osseointegrated bone-conduction device. Otol Neurotol 2013; 34(1):111-4.
  20. Baguley DM, Bird J, Humphriss RL et al. The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol 2006; 31(1):6-14.
  21. Lin LM, Bowditch S, Anderson MJ et al. Amplification in the rehabilitation of unilateral deafness: speech in noise and directional hearing effects with bone-anchored hearing and contralateral routing of signal amplification. Otol Neurotol 2006; 27(2):172-82.
  22. Kunst SJ, Leijendeckers JM, Mylanus EA et al. Bone-anchored hearing aid system application for unilateral congenital conductive hearing impairment: audiometric results. Otol Neurotol 2008; 29(1):2-7.
  23. Gluth MB, Eager KM, Eikelboom RH et al. Long-term benefit perception, complications, and device malfunction rate of bone-anchored hearing aid implantation for profound unilateral sensorineural hearing loss. Otol Neurotol 2010; 31(9):1427-34.
  24. Snik A, Leijendeckers J, Hol M et al. The bone-anchored hearing aid for children: recent developments. Int J Audiol 2008; 47(9):554-9.
  25. Marsella P, Scorpecci A, Pacifico C et al. Pediatric BAHA in Italy: the "Bambino Gesu" Children's Hospital's experience. Eur Arch Otorhinolaryngol 2012; 269(2):467-74.
  26. Davids T, Gordon KA, Clutton D et al. Bone-anchored hearing aids in infants and children younger than 5 years. Arch Otolaryngol Head Neck Surg 2007; 133(1):51-5.
  27. McDermott AL, Williams J, Kuo MJ et al. The role of bone anchored hearing aids in children with Down syndrome. Int J Pediatr Otorhinolaryngol 2008; 72(6):751-7.
  28. Dun CA, Faber HT, de Wolf MJ et al. Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. Otol Neurotol 2012; 33(2):192-8.
  29. Hobson JC, Roper AJ, Andrew R et al. Complications of bone-anchored hearing aid implantation. J Laryngol Otol 2010; 124(2):132-6.
  30. Wallberg E, Granstrom G, Tjellstrom A et al. Implant survival rate in bone-anchored hearing aid users: long-term results. J Laryngol Otol 2011; 125(11):1131-5.
  31. Kraai T, Brown C, Neeff M et al. Complications of bone-anchored hearing aids in pediatric patients. Int J Pediatr Otorhinolaryngol 2011; 75(6):749-53.
  32. Siegert R. Partially implantable bone conduction hearing aids without a percutaneous abutment (Otomag): technique and preliminary clinical results. Adv Otorhinolaryngol 2011; 71:41-6.
  33. Hol MK, Nelissen RC, Agterberg MJ et al. Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol 2013; 34(6):1071-5.
  34. Centers for Medicare and Medicaid Services. Medicare Policy Benefit Manual. Chapter 16 - General Exclusions from Coverage. Available online at: http://www.cms.gov/manuals/Downloads/bp102c16.pdf. Last accessed December 13, 2013.


Codes

Number

Description

CPT  See Policy Guidelines   
ICD-9 Procedure  20.95  Implantation of electromagnetic hearing device 
ICD-9 Diagnosis  380.15  Chronic mycotic otitis externa 
  380.16  Other chronic infective otitis externa NOS 
  380.23  Other chronic otitis externa NOS 
  380.52 Acquired stenosis of external ear canal secondary to surgery 
  381.3  Other and unspecified chronic non-suppurative otitis media 
  381.10–381.19  Chronic sensory otitis media code range 
  381.20–381.29  Chronic mucoid otitis media code range 
  382.0–382.9  Chronic suppurative and unspecified chronic otitis media code range 
  389.00–389.08  Conductive hearing loss code range 
  744.03  Anomaly of middle ear, except ossicles 
HCPCS L8690 Auditory osseointegrated device, includes all internal and external components
  L8691  Audotory osseointegrated device, external sound processor, replacement
  L8693 Auditory osseointegrated device abutment, any length, replacement only
ICD-10-CM (effective 10/1/15) H60.00 -H60.93 Otitis externa
   H61.30 -H61.399 Acquired stenosis of external ear canal code range
   H65.20 -H65.499;
H66.10 -H66.3x9
Chronic otitis media code range
   H90.0 -H90.8 Conductive and sensorineural hearing loss code range
   Q16.0 -Q16.9 Congenital malformations of ear causing impairment of hearing, code range
ICD-10-PCS (effective 10/1/15)   ICD-10-PCS codes are only used for inpatient services
   09HD051, 09HE051 Surgical, ear, nose & sinus, insertion, inner ear, open, hearing device, bone conduction, code for left or right
   0NH50SZ, 0NH53SZ, 0NH54SZ, 0NH60SZ, 0NH63SZ, 0NH64SZ Surgical, head & facial bones, insertion, temporal bone, hearing device, code by left or right, and approach (open, percutaneous, percutaneous endoscopic)
Type of Service  Surgery 
Place of Service  Outpatient 

 


Index  

Audiant™ Bone Conductor
Bone Anchored Hearing Aids, Semi-implantable
Hearing Aids, Bone Conduction, Implantable


Policy History  

Date Action Reason
12/01/95 Add to Surgery section New policy
07/31/97 Replace policy Reviewed with changes; description clarified
07/12/02 Replace policy Reviewed with changes; title changed to focus on category of implantable bone conduction hearing aids, as opposed to single device (i.e., Audiant). Policy statement unchanged, i.e., implantable bone conduction hearing aids may be considered medically necessary
12/17/03 Replace policy Policy reviewed by consensus without literature review; no changes in policy
09/27/05 Replace policy Policy statement revised to limit use to single sided deafness, consistent with FDA labeled indication. Audiologic criteria deleted
08/02/07 Replace policy Policy returned to active review status and updated with literature review through June 2007. Policy statements updated and clarified related to medically necessary unilateral and bilateral use in conductive hearing loss and in unilateral sensorineural hearing loss. Policy statement added concerning investigational uses, including bilateral sensorineural hearing loss. Reference numbers 5–11 added. Policy title changed to add “and Bone-Anchored” 
09/18/07 Replce policy-correction only Language added to Benefit Application section to clarify that the audiologic criteria apply to the affected ear.
10/07/08 Replace policy  Policy updated with literature review in September 2008; reference numbers 12 to 16 added. Policy statements unchanged.
01/13/11 Replace policy Policy revised with literature review. References 1, 4, 12, 13 and 21 added. Rationale rewritten. Audiologic criteria moved from policy guidelines to policy statement and revised to reflect FDA indications. Recommendation of presurgical trial of headband removed.
1/12/12 Replace policy Policy updated with literature review through November 2011; references 1-2, 7-8, 21, 25 added. Previous policy statements unchanged; added investigational policy statement for partially implantable hearing systems.
3/08/12 Replace policy- correction only Policy statements corrected by moving the "Otomag Alpha 1[M]" example to the investigational statememt.
1/10/13 Replace policy Policy updated with literature review through December 7, 2012. References 10, 16-18, 24 and 27 added; other references renumbered. Policy statements unchanged.
3/14/13 Replace policy -Correction only Policy No. 7.01.83 (archived 3/14/13) removed from Related Policies section
6/2013 Local policy created local policy to address Softband for children >5y.o. L8692
1/09/14 Replace policy Policy updated with literature review through December 13, 2013. References 3 and 33 added. Added “magnetic” and “BAHA Attract” to last policy statement but policy statements otherwise unchanged.