Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Bone-Anchored (Osseointegrated) Hearing Aids and Implantable Middle Ear Hearing Aids

Policy #:11.01.06d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

BONE-CONDUCTION HEARING AIDS

BONE-ANCHORED HEARING AIDS
Bone-Anchored Hearing Aids (Osseointegrated) Conductive or Mixed Hearing Loss

When a member has a benefit for hearing aids, a unilateral or bilateral fully- or partially- implantable bone-anchored (osseointegrated) hearing aid that is approved by the US Food and Drug Administration (FDA) is considered medically necessary as an alternative to an air-conduction hearing aid in individuals 5 years of age and older with a conductive or mixed hearing loss for any of the following conditions:
  • Congenital malformations of the external or middle ear
  • Chronic otitis media
  • Chronic otitis externa
  • Tumors of the external auditory canal or middle ear
  • Chronic dermatitis of the external auditory canal
  • Anatomical abnormalities of the external auditory canal and/or structures of the middle ear as a result of surgical treatment
  • Adverse effects of conventional hearing aids (e.g., pain, infection)

AND

The individual meets 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 BAHA BP100), 55dB (BAHA Intenso), or 65 dB (BAHA Cordelle II)

For bilateral implantation, individuals 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.

Bone-Anchored Hearing Aids (Osseointegrated) Single-Sided Sensorineural Deafness

When a member has a benefit for hearing aids, a bone-anchored (osseointegrated) hearing aid approved by the FDA is considered medically necessary and, therefore, covered when both of the following criteria are present:
  • As an alternative to an air-conduction contralateral routing of signal (CROS) hearing aid in individuals 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear
  • Pure tone average bone-conduction threshold in the better ear is 20 dB HL or better measured at 0.5 1, 2, and 3 kHz.

All other uses for bone-anchored (osseointegrated) hearing aids, including those with bilateral sensorineural hearing loss, are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

EXTERNAL SOUND PROCESSOR FOR AN AUDITORY OSSEOINTEGRATED DEVICE
An external sound processor for an auditory osseointegrated device used without osseointegration, body-worn, including a headband or other means of external attachment (L8692), is considered medically necessary and, therefore, covered for individuals who meet the above criteria for bone-anchored hearing aids (osseointegrated), and who are less than 5 years of age or do not have adequate bone mass to support the osseointegrated implant.

SEMI- AND TOTALLY IMPLANTABLE MIDDLE EAR HEARING AIDS

Although the US Food and Drug Administration (FDA) has approved several implantable middle ear hearing devices, the Company has determined that the safety and/or effectiveness of these devices cannot be established by review of the available published peer-reviewed literature. Therefore, implantable middle ear hearing devices (semi-implantable and totally implantable middle ear hearing devices) are considered experimental/investigational by the Company and not covered.

STATE-MANDATED BENEFIT REQUIREMENTS FOR COVERAGE OF HEARING AIDS

New Jersey (NJ) products have mandated benefits for the coverage and reimbursement of hearing aid devices. For specific mandates, refer to the following attachment to this policy:
  • Attachment A for New Jersey commercial products

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

When the bone-anchored, osseointegrated hearing aid is to be used in individuals with single-sided sensorineural deafness, it is recommended that a trial with a bone-anchored hearing aid device on a headband be placed on the mastoid of the deaf ear to determine the likely benefit of the device. Placement of bone-anchored implants are usually not performed for individuals younger than 5 years of age.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a bone-anchored (osseointegrated) hearing device is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, an implantable middle ear hearing device is not eligible for payment under the medical benefits of the Company’s commercial products because this device is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous bone-anchored (osseointegrated) hearing devices, partially implantable magnetic bone-conduction hearing systems, and implantable middle ear devices approved by the FDA.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the benefit contract is issued determine the mandated coverage.

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 for individuals with chronic middle ear and ear canal infections, atresia of the external canal, or an ear canal that cannot accommodate an ear mold. In these cases, bone-conduction hearing aids may be an alternative option.

BONE-CONDUCTION HEARING AIDS

External bone-conduction hearing aids function by transmitting sound waves through the bone directly to the inner ear. The external devices must be closely applied to the temporal bone, with a steel spring over the top of the head, a headband, or with the use of a spring-loaded arm on a pair of spectacles. The purpose of this type of hearing aid is to bypass the middle ear and transmit energy directly to the cochlea. These devices may be associated with pressure headaches or soreness.

BONE-ANCHORED HEARING AIDS
In contrast to external hearing aids, bone-anchored hearing aids are surgically implanted hearing devices. They consist of an external sound processor and a titanium implant, which is attached to the temporal bone of the skull. Bone-anchored hearing aids transmit sound directly to the inner ear through the bone, thus bypassing the external auditory canal and middle ear. While the bone-anchored hearing aids were originally used for individuals with conductive hearing loss and mixed hearing loss, in 2002, the FDA approved their use in individuals with unilateral sensorineural deafness. In these cases, a bone-anchored device located near the deaf ear works as a transcranial contralateral routing of signal (CROS) to transmit sound to the contralateral functional cochlea via bone conduction. This application has been evaluated as an alternative to the traditional air-conduction CROS hearing aid. Bone-anchored hearing aids are based on osseointegration, the process through which living tissue integrates with titanium in the implant, allowing amplified and processed sound to be conducted via the skull bone directly to the cochlea. Individuals must have sufficient bone integrity and mass to undergo the implant procedure.

PARTIALLY IMPLANTABLE MAGNETIC BONE-CONDUCTION HEARING SYSTEMS
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 magnet 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. The first partially implantable magnetic bone-conduction device, the Otomag Bone Conduction Hearing System, received 510(k) clearance from the FDA in 2011, followed by the BAHA Attract in 2013.

In a retrospective case series, Siegert (2011) reported on more than 100 individuals who had Otomag devices implanted over a 5-year period. While effectiveness outcomes related to hearing were not reported on, the author noted that except for temporary pressure marks in 4 percent of individuals, there were no other complications. Siegert concluded that the safety of the Otomag device system was significantly improved compared to conventional or percutaneous bone conduction hearing aids. Clinical and audiologic follow-up was ongoing, and results were simply the preliminary results (i.e., after fitting) of 12 individuals from the initial group of more than 100 individuals. The study is limited in its design, small sample size, short-term follow-up period, and lack of an appropriate comparative control group, which limits the validity of the study results.

Two prospective trials evaluating different transcutaneous systems were identified. Both trials were small (27 and 15 individuals, respectively), but both demonstrated improvements in hearing outcomes. Briggs et al (2015) reported on a prospective interventional evaluation of the percutaneous, partially implantable Baha Attract System among 27 adults with a conductive hearing loss (CHL) or mild mixed hearing loss in the ear to be implanted. 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 Abbreviated Profile of Hearing Aid Benefit (APHAB) overall score (p=0.038) and reverberation (p=0.016) and background noise (p=0.035) subscales improved.

Denoyelle et al (2015) 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. 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 air conduction (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 pure-tone average (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.

MIDDLE EAR HEARING AIDS

Implantable middle ear hearing devices transmit acoustic energy directly to the mobile structures within the middle ear space through the use of a vibrational transducer, thereby bypassing the external auditory canal. Compared to traditional air conduction hearing aids, implantable middle ear hearing devices are said to eliminate outer ear occlusion (i.e., the feeling of having a plugged ear canal) and feedback problems. They have the potential to provide greater amplification at higher frequencies and improve speech perception in the presence of background noise. They are theorized to provide a more natural sound compared to conventional hearing aids. Implantable middle ear hearing devices are generally classified as semi-implantable or totally implantable.

SEMI-IMPLANTABLE MIDDLE EAR DEVICES
Semi-implantable middle ear devices contain both externally and internally worn parts. The external parts are placed behind the ear. The devices use the periodic attraction and repulsion of two magnetic fields (one electromagnetic and one static magnetic) to cause vibration of the ossicles. This ultimately transmits sound to the inner ear. FDA-approved in August 2000, the Vibrant Soundbridge System™ is an alternative to traditional hearing aids for adults with a moderate to severe sensorineural hearing loss (i.e., occurs from damage to the inner ear, the auditory nerve, or the brain). The Soundtec Direct Device Hearing System™ was approved in September 2001 for the same indications, although it was subsequently discontinued in 2004. The Maxum System™ was approved in October 2009 and represents an upgrade over the Soundtec Direct Device Hearing System™.

In a prospective study as part of a phase II clinical trial, Hough et al. (2002) evaluated the safety and effectiveness of the Soundtec Direct System (since discontinued and now marketed as the Maxum System). One hundred and three individuals from 10 sites across the U.S. with bilateral moderate to moderately severe sensorineural hearing impairments received therapeutic intervention, including semi-implantable device implantation. Outcome measurements were taken after a 10-week healing period and included functional gain, speech recognition in quiet and noise, articulation index scores, perceived aid benefit, sound quality judgment, individual satisfaction, and the presence of feedback and occlusion. Compared with an optimally fit hearing aid, there was a statistically significant average increase of 5.3 percent in speech discrimination. While the mean speech perception in noise test scores were improved, it was not statistically significant. The authors concluded that the Soundtec Direct System provided statistically significant reductions in feedback and occlusive effect, as well as statistically significant improvements in functional gain, articulation index scores, speech discrimination in quiet, perceived aid benefit, satisfaction, and device preference. The study is limited in its relatively small sample size and short-term follow-up period.

In a systematic review, Tysome et al. (2010) evaluated whether semi-implantable middle ear implants improved hearing as much as hearing aids. Of 644 studies, 17 met the inclusion criteria for adults with a sensorineural hearing loss, and outcome measurements compared middle-ear implants with conventional hearing aids. Middle-ear implant outcome analyses included residual hearing, complications, and comparison to conventional hearing aids in terms of function gain, speech perception in quiet and in noise, and validated patient-reported outcome measurement questionnaires. The authors reported that the quality of the studies were moderate to poor, with short follow-up periods. The authors stated that the evidence supports the use of middle-ear implants because, overall, the semi-implantable middle ear implants did not decrease residual hearing, resulted in a function gain in hearing comparable to conventional hearing aids, and may improve perception of speech in noise and sound quality. The authors recommended that additional follow-up studies were warranted, with long-term results comparing middle-ear implants with conventional hearing aids. The systematic review is limited by the heterogeneity and poor quality of the included studies.

The limited data suggest semi-implantable middle ear hearing aids may provide marginal improvement in hearing compared with conventional external acoustic hearing aids in individuals with sensorineural hearing loss. However, given the safety and effectiveness of external acoustic hearing aids and the increased risks inherent in a surgical procedure, the semi-implantable device must be associated with clinically significant improvement in various hearing parameters compared with external hearing aids. While safety concerns appear to be minimal, only a limited number of individuals have been included in the clinical trials, and few have completed more than 1 year of follow-up. Given the small number of individuals and the limited safety data, risks cannot be adequately evaluated and compared with the marginal improvement in hearing. Studies on individuals with conductive or mixed hearing loss and aural atresia, when external acoustic hearing aids are not an option, have also demonstrated hearing benefit with semi-implantable middle ear hearing aids. However, these studies are few and limited to small numbers of individuals. Therefore, conclusions on the safety and effectiveness of semi-implantable hearing aids in these individuals cannot be made, and further study with longer term follow-up is needed. Comparisons of semi-implantable devices with alternative hearing devices such as implantable bone conduction and bone-anchored hearing aids would also be useful to determine device appropriateness for individuals who are unable to use external air-conduction hearing aids. Due to the lack of adequate safety data in broader populations over a longer period of time, semi-implantable middle ear hearing aids are investigational for all indications.

In 2013, Butler et al published results of a systematic review of comparative studies evaluating partially and fully implantable (discussed in following section) middle ear hearing devices for sensorineural hearing loss. The review included 14 studies, none of which were randomized controlled trials, 13 of which evaluated a semi-implantable device, most often the Vibrant Soundbridge, with 1 study evaluating the Envoy fully implantable system. Outcomes reported across studies were heterogeneous. Among the 9 studies that reported on the primary outcome (functional hearing gain), 1 found that middle ear implants were statistically significantly better than hearing aids, 1 found that hearing aids were statistically significantly better than implants, and 6 studies found that middle ear implants were better than hearing aids, but without a clinically significant difference. The authors concluded that middle ear implants were at least as effective as hearing aids in improving hearing outcomes.

A systematic review by Kahue et al (2014) evaluated studies of 3 FDA-approved middle ear hearing aids, the Vibrant Soundbridge, the Maxum System, and the Envoy Esteem (discussed in the following section). Studies eligible for inclusion addressed purely sensorineural hearing loss, had at least 5 implanted ears, and reported comparative data between preoperative and postoperative audiometric performance. Seventeen studies (503 ears) were included, 3 of which evaluated the Soundtec System (now Maxum System, 190 ears), 5 of which evaluated the Envoy Esteem (102 ears), and 9 of which evaluated the Vibrant Soundbridge (211 ears). The 14 studies comparing preoperative unaided hearing and postoperative middle ear implant-assisted hearing demonstrated improvement in hearing thresholds (weight mean, 25.2 dB improvement; range, 15.6-48.2 dB). However, for the 12 studies that compared the best aided preoperative condition with the postoperative assisted performance, the functional gain was smaller (weighted mean, 8.1 dB improvement; range, -9.4 to 13 dB), and only 1 reported statistically significant improvements over optimally fitting hearing aids. Similarly, studies that compared the preoperative unaided condition and the postoperative middle ear implant-assisted hearing demonstrated improvements in speech recognition (weighted average, 44.8% improvement; range, 8.8%-64.0%), while speech recognition was similar for the middle ear implant-assisted condition and best aided preoperative condition. Ten studies reported on safety outcomes, including 5 studies that focused on partially implantable middle ear implants; in those studies 15 (11.4%) of 132 implants had a malfunction that led to explantation.

One series with long-term follow-up (mean, 7.5 years) focused on middle ear implants in patients who failed external hearing aids. Zwartenkot et al (2013) described outcomes for 33 patients with moderate-to severe sensorineural hearing loss who had severe chronic otitis externa and were implanted with the Vibrant Soundbridge system or the Otologics MET system, a middle ear implant system not available in the United States. Compared with baseline, at long-term follow-up, subjects had statistically significant improvements in total scores on the Abbreviated Profile of Hearing Aid Benefit (63.3 at baseline vs 55.6 at follow-up, p<0.05). Eighty-five percent of subjects reported wearing the device more than 4 hours a day.

In summary, the evidence for use of semi-implantable middle ear hearing aids includes the clinical trials that supported FDA approval of the Vibrant Soundbridge and the Soundtec devices, along with a large number of observational series. Most available studies address the Vibrant Soundbridge device. For the use of semi-implantable middle ear hearing aids in patients with sensorineural hearing loss, the body of evidence suggests that these devices may be associated with a modest improvement in functional gain compared with external hearing aids, with similar improvements in speech recognition scores. Case series reporting on alternative coupling methods for the Vibrant Soundbridge for patients with conductive or mixed hearing loss (off-label uses) also report improved hearing thresholds and word recognition. Although the devices appear to have a good safety profile in the short term, studies in larger series reporting on longer term durability, safety, and efficacy are needed to permit conclusions about the devices’ risks and benefits relative to external hearing aids.

TOTALLY IMPLANTABLE MIDDLE EAR DEVICES
Totally implantable middle ear devices are used to treat moderate to severe hearing loss caused by defective inner ear function. The Esteem® system (FDA approved in March 2010) includes three implantable components (sound processor, sensor, and driver), in addition to external testing and programming instruments. To implant the device, the Esteem® requires disruption of the normal middle ear structure by partially removing the incus. Unlike hearing aids, this device does not use a microphone or speaker.

In a prospective, non-randomized “controlled” (each individual was their own control) trial, Kraus et al. (2011) evaluated the safety and effectiveness of the Esteem® system in 57 individuals with bilateral, mild to severe sensorineural hearing loss, with discrimination greater than 40 percent. Outcome measurements included hearing-related outcomes and the number of adverse events. Speech reception thresholds (minimum intensity in dBs at which an individual can understand 50 percent of spoken words) improved from 41.2dB to 29.4dB with the Esteem®. There were 6 serious adverse device events (2 wound infections, with one requiring explantation), 1 delayed facial paralysis, and 3 revisions due to limited benefit. The authors concluded that 12-month follow-up demonstrated that hearing results with the device were statistically significantly superior to baseline best-fit hearing aids. The study is limited in its small sample size, short-term follow-up period, and lack of a separate comparative control group.

In a systematic review, Klein et al. (2012) examined the safety and effectiveness of fully implantable middle ear devices for the treatment of hearing loss. Thirty studies were selected for full review, of which 7 studies were on the Esteem® system (representing 105 individuals) and 13 were on the Carina Fully Implantable Hearing Device (representing 68 individuals). The Carina Fully Implantable Hearing Device is not yet FDA approved. Complication rates with the Esteem® system were higher than with the Carina device. With regard to the Esteem® system, the most common adverse events included chorda tympani nerve damage or taste disturbance (30 percent). Facial weakness was also reported in 8 percent of individuals and was permanent in 2 individuals. Device failure was common with the Carina device, mainly due to charging difficulties. For both devices, clinically significant improvements in function gain, speech reception, and speech recognition over the unaided condition were reported.

In studies comparing the fully implantable middle ear devices to conventional hearing aids, findings were mixed. Although improvements in functional gain were similar to those of conventional hearing aids, speech recognition and quality of life were reportedly greater with the implants. The authors concluded that despite the limited evidence, fully implantable middle ear devices seem to offer a relatively safe and effective treatment option, particularly for individuals who are medically unable to wear conventional hearing aids. However, they noted that individuals should be informed of the relatively high risk of surgical complications involved with device implantation, particularly with the Esteem® device. The study is limited in the heterogeneity and low quality (e.g., small sample size, short-term follow-up) of its included studies.

In 2014, Pulcherio et al reported results of a systematic review of studies of 2 fully implantable middle ear hearing devices: the FDA-approved Esteem device and the Carina device, which does not have FDA approval. The review included 22 studies with a total of 244 patients, 134 implanted with the Esteem device and 110 with the Carina device. No randomized controlled trials were identified, and most studies were small, with the largest series including 57 subjects and 12 series including fewer than 10 subjects. All studies showed improvement of sound field threshold from unaided to aided conditions with the fully implantable device, but the magnitudes of the improvements varied.

A case series published since the Pulcherio and the Klein systematic reviews reported high rates of facial nerve palsies (10/34 subjects [29.4%]) after implantation of the Esteem device, which persisted to 3 months of follow-up in 6 (17.6%) of 34 subjects.

In summary, the evidence for use of fully implantable middle ear hearing aids includes the clinical trial that supported FDA approval of the Esteem device, along with systemic reviews and small observational series that report short-term results. These studies generally found improved hearing over unaided hearing, with modest improvements over hearing with best-fit aids. The available evidence for use of fully implantable middle ear hearing aids, however, is insufficient to demonstrate long term improvement in net health outcome. Concerns exist about adverse events with these devices. Therefore, fully implantable middle ear hearing aids are considered investigational.
References

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den Besten CA, Nelissen RC, Peer PG, et al. A retrospective cohort study on the influence of comorbidity on soft tissue reactions, revision surgery, and implant loss in bone-anchored hearing implants. Otol Neurotol. 2015;36(5):812-818.

Denoyelle F, Coudert C, Thierry B, et al. 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. 2015;79(3):382-387.

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

Dillon MT, Tubbs RS, Adunka MC, et al. Round window stimulation for conductive and mixed hearing loss. Otol Neurotol. 2014;35(9):1601-1608.

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

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.

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.

Ernst A, Todt I, Wagner J. Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: A systematic review. Laryngoscope. 2016;126(6):1451-7.

Faber HT, Nelissen RC, Kramer SE, et al. Bone-anchored hearing implants in single-sided deafness patients: Long-term use and satisfaction by gender. Laryngoscope. 2015;125(12):2790-2795.

Farnoosh S, Mitsinikos FT, Maceri D, et al. 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.

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

Frenzel H, Sprinzl G, Streitberger C, et al. The Vibrant Soundbridge in children and adolescents: preliminary european multicenter results. Otol Neurotol. 2015;36(7):1216-1222.

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

Gerard JM, Thill MP, Chantrain G, et al. Esteem 2 middle ear implant: our experience. Audiol Neurootol. 2012;17(4):267-274.

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):1427-1434.

Granstrom G, Tjellstrom A. The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J. 1997;76(4):238-240, 42, 44-47.

Gunduz B, Atas A, Bayazit YA, et al. Functional outcomes of Vibrant Soundbridge applied on the middle ear windows in comparison with conventional hearing aids. Acta Otolaryngol. 2012; 132(12):1306-10.

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

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):891-896.

Hobson JC, Roper AJ, Andrew R, et al. Complications of bone-anchored hearing aid implantation. J Laryngol Otol. 2010;124(2):132-136.

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):1071-1075.

Hough JV, Matthews P, Wood MW, Dyer RK Jr. Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial. Otol Neurotol. 2002;23(6):895-903.

House JW, Kutz JW Jr. Bone-anchored hearing aids: incidence and management of postoperative complications. Otol Neurotol. 2007;28(2):213-217.

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

Ihler F, Volbers L, Blum J, et al. 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. 2014;35(2):211-215.

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

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

Janssen RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing a systematic review. Otolaryngol Head Neck Surg. 2012;147(3):412-422.

Kahue CN, Carlson ML, Daugherty JA, et al. Middle ear implants for rehabilitation of sensorineural hearing loss: a systematic review of FDA approved devices. Otol Neurotol. 2014;35(7):1228-1237.

Kam AC, Sung JK, Yu JK, et al. Clinical evaluation of a fully implantable hearing device in six patients with mixed and sensorineural hearing loss: our experience. Clin Otolaryngol. 2012; 37(3):240-244.

Kiringoda R, Lustig LR. A meta-analysis of the complications associated with osseointegrated hearing aids. Otol Neurotol. 2013;34(5):790-794.

Klein K, Nardelli A, Stafinski T. A systematic review of the safety and effectiveness of fully implantable middle ear hearing devices: the carina and esteem systems. Otol Neurotol. 2012; 33(6):916-921.

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

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

Kraus EM, Shohet JA, Catalano PJ. Envoy Esteem Totally Implantable Hearing System: phase 2 trial, 1-year hearing results. Otolaryngol Head Neck Surg. 2011;145(1):100-109.

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

Kunst SJ, Hol MK, Mylanus EA, et al. Subjective benefit after BAHA system application in patients with congenital unilateral conductive hearing impairment. Otol Neurotol. 2008;29(3):353-358.

Larsson A, Tjellstrom A, Stalfors J. Implant losses for the bone-anchored hearing devices are more frequent in some patients. Otol Neurotol. 2015;36(2):336-340

Laske RD, Roosli C, Pfiffner F, et al. Functional results and subjective benefit of a transcutaneous bone conduction device in patients with single-sided deafness. Otol Neurotol. 2015;36(7):1151-1156.

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

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):172-182.

Luetje CM, Brackman D, Balkany TJ, et al. Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study. Otolaryngol Head Neck Surg. 2002;126(2):97-107.

Magliulo G, Turchetta R, Iannella G, et al. Sophono Alpha System and subtotal petrosectomy with external auditory canal blind sac closure. Eur Arch Otorhinolaryngol. 2015;272(9):2183-2190.

Mandala M, Colletti L, Colletti V. Treatment of the atretic ear with round window vibrant soundbridge implantation in infants and children: electrocochleography and audiologic outcomes. Otol Neurotol. 2011;32(8):1250-1255.

Marino R, Linton N, Eikelboom RH, et al. A comparative study of hearing aids and round window application of the vibrant sound bridge (VSB) for patients with mixed or conductive hearing loss. Int J Audiol 2013;52(4):209-218.

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

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):467-474.

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

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):751-757.

McLarnon CM, Davison T, Johnson IJ. Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope. 2004;114(5):942-944.

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

Monini S, Biagini M, Atturo F, et al. Esteem((R)) middle ear device versus conventional hearing aids for rehabilitation of bilateral sensorineural hearing loss. Eur Arch Otorhinolaryngol.2013.Jul;270(7):2027-2033.

My Maxum. Important Safety Information. 2014. Available at: http://mymaxum.com/important-safety-information/. Accessed June 15, 2018.

Nelissen RC, Agterberg MJ, Hol MK, et al. Three-year experience with the Sophono in children with congenital conductive unilateral hearing loss: tolerability, audiometry, and sound localization compared to a bone-anchored hearing aid. Eur Arch Otorhinolaryngol. 2016;273(10):3149-3156.

Nelissen RC, Stalfors J, de Wolf MJ, et al. 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. 2014;35(8):1486-1491.

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):111-114.

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):751-755.

Peters JP, Smit AL, Stegeman I, et al. Review: Bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. 2015;125(1):218-226.

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

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

Pulcherio JO, Bittencourt AG, Burke PR, et al. Carina(R) and Esteem(R): a systematic review of fully implantable hearing devices. PLoS One. 2014;9(10):e110636.

Rahne T, Seiwerth I, Gotze G, et al. Functional results after Bonebridge implantation in adults and children with conductive and mixed hearing loss. Eur Arch Otorhinolaryngol. 2015;272(11):3263-3269.

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):153-157.

Rebol J. Soft tissue reactions in patients with bone anchored hearing aids. Ir J Med Sci. 2015;184(2):487-491.

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

Riss D, Arnoldner C, Baumgartner WD, et al. Indication criteria and outcomes with the Bone bridge transcutaneous bone-conduction implant. Laryngoscope. 2014;124(12):2802-2806.

Roman S, Denoyelle F, Farinetti A, et al. Middle ear implant in conductive and mixed congenital hearing loss in children. Int J Pediatr Otorhinolaryngol. 2012;76(12):1775-1778.

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

Schmerber S, Deguine O, Marx M, et al. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. 2017;274(4):1835-1851.

Siegert R. Partially implantable bone conduction hearing aids without a percutaneous abutment (Otomag): technique and preliminary clinical results. Adv Otorhinolaryngol. 2011;71:41-46.

Silverstein H, Atkins J, Thompson JH Jr, Gilman N. Experience with the SOUNDTEC Implantable hearing aid. Otol Neurotol. 2005;26(2):211-217.

Singam S, Williams R, Saxby C, et al. Percutaneous bone-anchored hearing implant surgery without soft-tissue reduction: up to 42 months of follow-up. Otol Neurotol. 2014;35(9):1596-1600.

Skarzynski H, Olszewski L, Skarzynski PH, et al. Direct round window stimulation with the Med-El Vibrant Soundbridge: 5 years of experience using a technique without interposed fascia. Eur Arch Otorhinolaryngol. 2014;271(3):477-482.

Snapp HA, Holt FD, Liu X, et al. 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.2017;38(1):11-18.

Snik A, Leijendeckers J, Hol M, et al. The bone-anchored hearing aid for children: recent developments. Int J Audiol. 2008;47(9):554-559.

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.

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.

State of New Jersey (NJ). Department of Banking and Insurance (DOBI). PL 2008, c. 126 – Health Benefits Coverage for Hearing Aids for Children. [NJ DOBI]. 05/15/09. Available at: http://www.state.nj.us/dobi/bulletins/blt09_17.pdf. Accessed June 15, 2018.

State of New Jersey (NJ). NJ Department of Human Services. Division of the Deaf and Hard of Hearing. Consumer Guide to Grace's Law. July/August 2009. Vo. 30, No. 7. [newsletter]. Trenton, NJ. Available at:http://www.nj.gov/humanservices/ddhh/newsletters/communicator/archive/2009MCs/MCJulAug09.pdf. Accessed June 15, 2018.

Sterkers O, Boucarra D, Labassi S, et al. A middle ear implant, the Symphonix Vibrant Soundbridge: retrospective study of the first 125 patients implanted in France. Otol Neurotol. 2003;24(3):27-36.

Sziklai I, Szilvassy J. Functional gain and speech understanding obtained by Vibrant Soundbridge or by open-fit hearing aid. Acta Otolaryngol. 2011;131(4):428-433.

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):1461-1464.

Truy E, Philibert B, Vesson JF, et al. Vibrant soundbridge versus conventional hearing aid in sensorineural high-frequency hearing loss: a prospective study. Otol Neurotol. 2008;29(5):684-687.

Tsang WS, Yu JK, Wong TK, et al. Vibrant Soundbridge system: application of the stapes coupling technique. J Laryngol Otol. 2013;127(1):58-62.

Tysome JR, Moorthy R, Lee A, et al. Systematic review of middle ear implants: do they improve hearing as much as conventional hearing AIDS? Otol Neurotol. 2010;31(9):1369-1375.

Uhler K, Anderson MC, Jenkins HA. Long-term outcome data in patients following one year's use of a fully implantable active middle ear implant. Audiol Neurootol. 2016;21(2):105-112.

University of Maryland Medical Center (UMMC). Maryland Hearing and Balance Center. What is a BAHA? [UMMC Web site]. http://www.umm.edu/otolaryngology/baha.htm. Accessed June 15, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. BAHA BP100. 510(k) summary. [FDA Web site]. 06/17/09. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090720.pdf. Accessed June 15, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. BAHA Cordelle II. 510(k) summary. [FDA Web site]. 04/10/08. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080363.pdf. Accessed June 15, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. BAHA Divino. 510(k) summary. [FDA Web site].08/26/04. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042017.pdf. Accessed June 15, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. OBC Bone anchored hearing aid system. 510(k) summary. [FDA Web site]. 11/14/08. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082108.pdf. Accessed June 15, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Branemark Anchored Hearing Aid (BAHA TM) System. 510(k) summary. [FDA Web site]. 06/28/99. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K984162.pdf. Accessed June 15, 2018.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
69714, 69715, 69717, 69718


EXPERIMENTAL/INVESTIGATIONAL
69710, 69711

THE FOLLOWING CODE IS USED TO REPRESENT SEMI OR FULLY IMPLANTABLE MIDDLE EAR HEARING DEVICES:
69799


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

H90.0 Conductive hearing loss, bilateral

H90.11 Conductive hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.12 Conductive hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.2 Conductive hearing loss, unspecified

H90.41 Sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.42 Sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.6 Mixed conductive and sensorineural hearing loss, bilateral

H90.71 Mixed conductive and sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.72 Mixed conductive and sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.A11 Conductive hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A12 Conductive hearing loss, unilateral, left ear with restricted hearing on the contralateral side

H90.A31 Mixed conductive and sensorineural hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A32 Mixed conductive and sensorineural hearing loss, unilateral, left ear with restricted hearing on the contralateral side

EXPERIMENTAL/INVESTIGATIONAL FOR BONE-ANCHORED (OSSEOINTEGRATED) HEARING AIDS

H90.3 Sensorineural hearing loss, bilateral

H90.5 Unspecified sensorineural hearing loss

H90.A21 Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side

H90.A22 Sensorineural hearing loss, unilateral, left ear, with restricted hearing on the contralateral side



HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

L8618 Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement

L8624 Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each

L8625 External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each

L8690 Auditory osseointegrated device, includes all internal and external components

L8691 Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each

L8692 Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other means of external attachment

L8693 Auditory osseointegrated device abutment, any length, replacement only

L8694 Auditory osseointegrated device, transducer/actuator, replacement only, each


EXPERIMENTAL/INVESTIGATIONAL

S2230 Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear

V5095 Semi-implantable middle ear hearing prosthesis



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A : Bone-Anchored (Osseointegrated) Hearing Aids and Implantable Middle Ear Hearing Aids
Description: NJ STATE MANDATE FOR HEARING AIDS, ACCESSORIES, AND RELATED SERVICES (GRACE'S LAW)




Policy History

11.01.06d:
07/18/2018As of 7/18/2018, this policy has been reviewed and reissued to communicate the Company’s continuing position on bone-anchored (osseointegrated) hearing aids and implantable middle ear hearing aids
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.

The following HCPCS codes have been added to this policy:
L8618, L8624, L8625, L8694

The following narrative has been revised in this policy: L8691
Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: 07/18/2018

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