Clinical Policy Title: Semi or fully implantable middle ear hearing aids

Transcription

1 Clinical Policy Title: Semi or fully implantable middle ear hearing aids Clinical Policy Number: CCP.1396 Effective Date: September 1, 2018 Initial Review Date: July 3, 2018 Most Recent Review Date: August 1, 2018 Next Review Date: August 2019 Policy contains: Fully implantable hearing aids. Semi implantable hearing aids. Sensorineural hearing loss. Related policies: CCP.1080 Bone-anchored hearing aids and cochlear implants ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice s clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of semi or fully implantable middle ear hearing aids to be investigational/experimental and, therefore, not medically necessary. Limitations: Coverage determinations are subject to benefit limitations and exclusions as delineated by the state Medicaid authority. The Florida Medicaid website may be accessed at Alternative covered services: Cochlear implants. Conventional hearing aids. 1

2 Background Hearing loss is a prevalent condition. About 20 percent of Americans have some degree of hearing loss, a figure that rises to one in three for the elderly. About 60 percent of persons with hearing loss are either in the work force or educational settings. About 15 percent of school-aged children have some degree of hearing loss (Hearing Loss Association of America, 2018). Among adults ages 45 54, two percent have disabling hearing loss, a figure that rises to 8.5 percent, 25 percent, and 50 percent at ages 55 64, 65 74, and 75 and over, respectively (National Institute on Deafness and Other Communication Disorders, 2016). Hearing loss can be either conductive (due to problems with the ear canal, ear drum, or middle ear bones) or sensorineural (due to problems with the inner ear). Some persons have hearing loss with characteristics of both types. Hearing loss can often be treated with medical management, surgery, or hearing aids (Hearing Loss Association of America, 2018). While an estimated 28.8 million Americans could benefit from hearing aids (National Institute on Deafness and Other Communication Disorders, 2016), few of them actually wear these devices. A national survey determined that just one in four Americans with hearing loss has a hearing aid (Kochin, 2009). There are three major types of hearing aids: 1. Behind-the-ear hearing aids are made of hard plastic and worn behind the ear, and connected to a plastic ear mold that fits inside the outer ear. 2. In-the-ear hearing aids are worn inside the outer ear, featuring a hard plastic case holding electric components. 3. Canal aids fit in the ear canal, sometimes nearly hidden (National Institute on Deafness and Other Communication Disorders, 2017). In cases of moderate to severe sensorineural hearing loss, patients are often fitted with external acoustic hearing aids. These devices are not indicated for some patients with moderate to severe sensorineural hearing loss, because of problems with fitting the device, quality of the sound, or personal preference. Fully and semi-implantable middle ear hearing aids are now in use as an alternative. These products include (with manufacturers and dates of approval from the U.S. Food and Drug Administration): Vibrant Soundbridge (MED-El Corporation, Innsbruck, Austria), for semi-implantable devices, approved 2000; the first approved device of its kind, it has been distributed since Maxum (Ototronix LC, Houston, Texas), for semi-implantable devices, approved 2009, replacing SOUNDTEC Direct System TM, discontinued 2004 (Pelosi, 2014). Esteem Implantable Hearing System (Envoy Medical Corporation, Minneapolis, Minnesota), for fully implantable devices, approved Carina Fully Implantable Hearing Device (Otologics LLC, Boulder, Colorado), for fully implantable devices, no approval to date (Bittencourt, 2014). 2

3 While each device improves hearing, there are differences between them. The Vibrant Soundbridge is implanted behind the ear, with the processor worn externally. The Maxum is placed in the ear canal, with the processor situated over the external ear. The Esteem system is fully implanted in the middle ear, with a sensor at the head of the incus. The Vibrant Soundbridge comprises the surgically implanted receiver/demodulator and the external audio processor placed on the scalp and held in place by magnetic attraction. Likewise, criteria for use vary between products. The Vibrant Soundbridge is for adults over age 18 with malformations of the outer or middle ear that had little or no benefit (or contraindication) to conventional hearing aids; these adults also have moderate to severe sensorineural, conductive, or mixed hearing loss stable for more than two years (Bittencourt, 2014). Searches Prestige Health Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. We conducted searches on May 18, Search terms were: implantable hearing aids, Soundbridge, Soundtec, Maxum, Esteem, and Carina. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings In 1986, the American Academy of Otolaryngology-Head and Neck Surgery issued a position statement stating that middle ear implants were appropriate treatment for adults with moderate to severe hearing loss, based on literature that supports a benefit for selected adults that do not improve from using conventional hearing aids. The (brief) statement has been updated numerous times since (American Academy of Otolaryngology Head and Neck Surgery, 2016). 3

4 Because the various types of fully and semi-implantable middle ear hearing aids are relatively new, data on safety and efficacy is only recently emerging. A July 2014 article about these devices termed implantable devices as still in the early stages of development, but predicted that they will be a major driver of improving hearing problems in the 21st century, especially given the aging population (Bittencourt, 2014). Most articles on implantable hearing aids address the adult population. A consensus meeting on performance of the Vibrant Soundbridge implant determined that among children, the device improved outcomes for hearing thresholds and speech intelligibility in quiet and noise, with few complications. However, with just 60 children under 18 worldwide having had Soundbridge implants as of the meeting, patients and caregivers were advised to also consider other treatment options (Cremers, 2010). Perhaps the earliest systematic review on implantable middle ear hearing aids included 30 studies, of which seven addressed Esteem and 13 addressed Carina, both fully implantable. Most of the studies were quasi-experimental. Complication rates with Esteem exceeded those with Carina, mostly taste disturbance. Device failure was common with Carina. For both devices, clinically significant improvements in functional gain, speech reception, and speech recognition over the unaided condition were found. Evidence was termed limited even though improvements in function were observed, and both were deemed safe (Klein, 2012). Another systematic review of the fully implantable Carina and Esteem included a total of 22 studies and two literature reviews (n = 244), followed two to 29.4 months. Authors describe their comparison of ability to recognize words as difficult, as there was no standardization of measurement even though outcomes for treated patients were subjectively improved. The study cautioned care in extrapolating results to a broader population, since no randomized controlled trials were included (Pulcherio, 2014). A systematic review of 14 studies included nine that reported on functional gain for persons with middle-ear implants and those with external hearing aids. Only two of nine studies had significant results one finding superior outcomes for middle-ear implants (P <.001) and one finding superior outcomes for external hearing aids (P <.05). Other studies were not significantly different, and the study concluded active middle-ear implant was equally effective as external hearing aids (Butler, 2013). A systematic review of 22 articles, one conference proceeding, and one Food and Drug Administration report addressed safety and efficacy of Vibrant Soundbridge, a semi-implantable hearing aid introduced in the late 1990s, making it the oldest and most-used middle ear implant worldwide (Labassi, 2017). All but one of the 24 articles (n = 679) were from Europe. Patients were followed mostly from two to 24 months. Adverse effects from seven studies were described as low, including aural fullness, implant failure, and taste disturbance (27 percent, 14 percent, and 9 percent). Among outcomes, observed hearing preservation in 10 studies was typically 1 3 decibels, a clinically non-significant shift. The only control in the study was 56 cases using the Esteem hearing aid. Nine studies were Oxford Level 3 studies 4

5 and 14 were Level 4 studies (low quality, typically just case series). Vibrant Soundbridge was deemed to be highly reliable and safe (Bruchhage, 2017). Another systematic review published less than a year before the one cited above, also addressed the Vibrant Soundbridge (19 studies, n = 294). All studies in the review compared patients using the device versus unaided patients, and thus the evidence was judged to be Level 3 or 4 (low quality). In 13 of the studies (n = 196), 32 adverse events were observed, a 16.3 percent rate. Functional gains were reported, compared with no treatments. Speech recognition improvements ranged from 63 percent 99 percent at three months, and 52 percent 81 percent at six months. The authors did warn that heterogeneous data made the attempt to draw conclusions more difficult (Ernst, 2016). Despite these two large reviews, some journal articles still find no advantage of Vibrant Soundbridge over conventional hearing aids. One study cites improved patient satisfaction, but only when linked with intolerance of conventional hearing aids, severe mixed hearing loss with a destructed middle ear, and certain medical diagnoses (Luers, 2014). Aside from Vibrant Soundbridge, the other approved semi-implantable hearing aid is Maxum. Studies show promising results, but there are few such analyses with very small sample sizes of fewer than 10 subjects each (Barbara, 2018; Dyer, 2018; Chang, 2017). Research on Esteem and Carina, the fully implantable model hearing aids, is still limited, aside from the two systematic reviews referred to earlier that compared outcomes for these products (Pulcherio, 2014; Klein, 2012). Probably the publication on Esteem with the largest patient population is the outcome of the clinical trial that led to government approval, including 57 subjects (Kraus, 2011), with few trials comparing Esteem to controls other than Carina. Carina has been compared with conventional hearing aids for conduction thresholds, but these studies are few in number and small in size, the most recent one being only nine patients (Savas, 2016). Another study (n = 62) documented positive results for patient satisfaction and daily use, with no objective clinical measures (Lefebvre, 2016). A study of device failure (n = 128) compared Vibrant Soundbridge, otologics middle ear transducer, and otologics fully implantable ossicular stimulator. The Soundbridge only had a seven percent failure rate, substantially lower than the other two (28 percent and 100 percent) (Zwartenkot, 2016). While the number of systematic reviews continues to increase, there several factors that limit the ability of evidence in the literature to document medical necessity. Such reviews are still few in number, as are the number of trials that are randomized and controlled; sample sizes are typically small; and the quality of data is often limited (due to heterogeneity that hampers comparisons). Policy updates: 5

6 None. Summary of clinical evidence: Citation Bruchhage (2017) Content, Methods, Recommendations Key points: Safety and efficacy of Vibrant Soundbridge semiimplantable hearing aid Systematic review of 22 articles, one conference proceeding, and one Food and Drug Administration report (n = 679), all but one from Europe. Nine and 14 studies were Oxford Level 3 4, low quality. Patients were followed mostly from two to 24 months. Adverse effects from seven studies were described as low, including aural fullness, implant failure, and taste disturbance (27 percent (%), 14%, and 9%, respectively). Hearing preservation in 10 studies was mostly 1 3 decibels, clinically non-significant. The only control in the study was 56 cases using Esteem implants. Vibrant Soundbridge was deemed to be highly reliable and safe by authors. Audiological outcomes include hearing thresholds, functional gain, speech perception in quiet and noise, speech recognition thresholds, and real ear insertion gain. Ernst (2016) Performance of Vibrant Soundbridge Pulcherio (2014) Performance of various fully implantable hearing aids Butler (2013) Key points: Systematic review of performance of the Visual Soundbridge (19 studies, n = 294). All studies in the review were comparisons of Soundbridge versus no treatments; evidence of low quality. In 13 of the 19 studies, 32 adverse events occurred (16.3%). Functional gains were reported, including speech recognition improvements (63 99% at three months, 52 81% at six months). Article notes heterogeneous data made the attempt to draw conclusions more difficult. Key points: Systematic review of the fully implantable Carina and Esteem (22 studies, n = 244). Subjects were followed for two to 29.4 months. Comparison of ability to recognize words as difficult, as there was no standardization of measurement, even though outcomes for treated patients were subjectively improved. Cautioned care in extrapolating results to a broader population (no randomized controlled trials included). Key points: Middle ear implants versus external hearing aids Systematic review of 14 studies; nine reported functional gain for persons with middle ear implants or external hearing aids. Only two of nine studies had significant results one with superior outcomes for middle ear implants (P <.001) and one with superior outcomes for external hearing aids (P <.05). Other studies were not significantly different. Study concluded active middle ear implant was as effective as external hearing aids. 6

7 Citation Klein (2012) Content, Methods, Recommendations Key points: Performance comparison of fully implantable hearing aids Systematic review on implantable middle ear hearing aids in 30 studies (seven on Esteem, 13 on Carina). Most studies were quasi-experimental. Complication rates with Esteem exceeded those with Carina, mostly taste disturbance. Device failure was common with Carina. For both devices, clinically significant improvements in functional gain, speech reception, and speech recognition over the unaided condition observed. Evidence was limited, even though improvements in function were observed, and both were deemed safe. References Professional society guidelines/other: American Academy of Otolaryngology Head and Neck Surgery. Position Statement: Active Middle Ear Implants. Alexandria VA: American Academy of Otolaryngology Head and Neck Surgery, last reviewed September 13, Accessed May 18, Hearing Loss Association of America. Basic Facts About Hearing Loss. Bethesda MD: Hearing Loss Association of America, Accessed May 18, Kochin S. Market Trak VIII: 25-Year Trends in the Hearing Health Market. The Hearing Review. 2009;16(11): Accessed May 18, National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing. Bethesda MD: National Institute on Deafness and Other Communication Disorders, last updated December 15, Accessed May 18, National Institute on Deafness and Other Communication Disorders. Hearing Aids. Bethesda MD: National Institute on Deafness and Other Communication Disorders, last updated March 6, Accessed May 18, Peer-reviewed references: 7

8 Barbara M, Volpini L, Filippi C, Atturo F, Monini S. A new semi-implantable middle ear implant for sensorineural hearing loss: three-years follow-up in a pilot patient s group. Acta Otolaryngol. 2018;138(1): Doi: / Bittencourt AG, Burke PR, Jardim Ide S, et al. Implantable and semi-implantable hearing AIDS: a review of history, indications, and surgery. Int Arch Otorhinolaryngol. 2014;18(3): Doi: /s Bruchhage KL, Leichtle A, Schonweiler R, et al. Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2017;274(4): Doi: /s Butler CL, Thavaneswaran P, Lee IH. Efficacy of the active middle-ear implant in patients with sensorineural hearing loss. J Laryngol Otol. 2013;127 Suppl 2:S8-16. Doi: 1017/S Chang CYJ, Spearman M, Spearman B, McCraney A, Glasscock ME 3 rd. Comparison of an electromagnetic middle ear implant and hearing aid word recognition performance to work recognition performance obtained under earphones. Otol Neurotol. 2017;38(9): Doi: /MAO Cremers CW, O Connor AF, Helms J, et al. International consensus on Vibrant Soundbridge implantation in children and adolescents. Int J Pediatr Otorhinolaryngol. 2010;74(11): Doi: /j.ijporl Dyer RK, Spearman M, Spearman B, McCraney A. Evaluating speech perception of the MAXUM middle ear implant versus speech perception under inserts. Laryngoscope. 2018;128(2): Doi: /lary 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): Doi: /lary 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): Doi: /MAO.0b013e31825f230d. 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): Doi: / Labassi S, Beliaeff M, Pean V, Van de Heyning P. The Vibrant Soundbridge middle ear implant: A historical overview. Cochlear Implants Int. 2017;18(6): Doi: /

9 Lefebvre PP, Gisbert J, Cuda D, Tringali S, Deveze A. A retrospective multicenter cohort review of patient characteristics and surgical aspects versus the long-term outcomes for recipients of a fully implantable active middle ear implant. Audiol Neurootol. 2016;21(5): Doi: / Luers JC, Huttenbrink KB. Vibrant Soundbridge rehabilitation of conductive and mixed hearing loss. Otolaryngol Clin North Am. 2014;47(6): Doi: /j.otc Pelosi S, Carlson ML, Glasscock ME 3 rd. Implantable hearing devices: the Ototronix MAXUM system. Otolaryngol Clin North Am. 2014;47(6): Doi: /j.otc Pulcherio JO, Bittencourt AG, Burke PR, et al. Carina and Esteem : a systematic review of fully implantable hearing devices. PLoS One. 2014;9(10):e Doi: /journal.pone Savas VA, Gunduz B, Karamert R, et al. Comparison of Carina active middle-ear implant with conventional hearing aids for mixed hearing loss. J Laryngol Otol. 2016;130(4): Doi: /S Zwartenkot JW, Mulder JJ, Snik AF, Cremers CW, Mylanus EA. Active middle ear implantation: long-term medical and technical follow-up, implant survival, and complications. Otol Neurotol. 2016;37(5): Doi: /MAO Centers for Medicare & Medicaid Services National Coverage Determinations: No National Coverage Determinations identified as of the writing of this policy. Local Coverage Determinations: No Local Coverage Determinations identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Unlisted procedure, middle ear ICD-10 Code Description Comments H90.3 Sensorineural hearing loss, bilateral H H90.42 Sensorineural hearing loss with unrestricted hearing on contralateral side code range 9

10 ICD-10 Code Description Comments H90.5 Sensorineural hearing loss unspecified HCPCS Level II Code S2230 V5095 Description Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear Semi-implantable middle ear hearing prosthesis Comments 10