Latest Review Date: March 2024

Category: Surgery                                                                 

POLICY:

Semi-implantable middle ear hearing aids for moderate to severe sensorineural hearing loss are considered investigational.

Fully implantable middle ear hearing aids (e.g. Esteem^® implantable hearing system) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Moderate-to-severe sensorineural hearing loss is often treated with external acoustic hearing aids, while conductive hearing loss can be treated with acoustic or bone-conduction hearing aids when surgical or medical interventions do not correct hearing loss. Semi-implantable and fully implantable middle ear hearing aids detect sound and transduce signals directly to the ossicles in the middle ear and have been used as an alternative to external acoustic hearing aids.

Hearing Loss

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 decibels (dB). The American Speech Language- Hearing Association (ASLHA) has defined the degree of hearing loss based on pure-tone average (PTA) detection thresholds as mild (20 - 40 dB), moderate (40 - 60 dB), severe (60 - 80 dB), and profound (> 80 dB).

Treatment

Sound amplification through the use of an air-conduction (AC) hearing aid can provide benefit to patients with sensorineural, conductive, or mixed hearing loss. Contralateral routing of signal is a system in which a microphone on the affected side transmits a signal to an air-conduction hearing aid on the normal or less affected side.

Patients with moderate to severe sensorineural hearing loss are typically fitted with external acoustic hearing aids. Conductive hearing loss may be treated with acoustic or bone conduction hearing aids when surgical or medical interventions are unable to correct hearing loss. However, these hearing aids may not be acceptable to patients, either due to issues related to anatomic fit, sound quality, or personal preference. In some cases, external acoustic hearing aids may not be able to be used due to external ear pathologies (e.g., otitis externa).

Semi-and Fully- Implantable Middle Ear Hearing Aids

Semi-implantable and fully implantable middle ear hearing aids are alternatives to external acoustic hearing aids. Two semi-implantable devices have Food and Drug Administration (FDA) approval, the Vibrant^® Soundbridge^™ (MED-EL Corporation, Durham, NC) and the Maxum^™ System (Ototronix, Houston, TX).

The devices consist of components: a magnet that is implanted onto the ossicles of the middle ear, a receiver, and a sound processor. The Soundbridge device is implanted subcutaneously behind the ear while the processor is worn externally on the scalp over the receiver unit and held in place by a magnet. The Maxum^™ System device is placed in the user’s ear canal while the processor rests over the external ear. In general, the sound processor receives and amplifies the sound vibrations and transforms the sound pressure into electrical signals received by the receiver unit. The receiver unit then transduces these electrical signals into electromagnetic energy and creates an alternating electromagnetic field with the magnetic component (floating mass transducer) implanted on the ossicles of the middle ear. This electromagnetic field results in attractive and repulsive forces on the magnetic implant, causing vibration of the bones of the middle ear similar to normal hearing.

One fully implantable middle ear hearing aid has the FDA approval: the Esteem^®Implantable Hearing System. Similar to the semi-implantable devices, the fully implantable device consists of a sensor, a sound processor, and a driver connected to the ossicles. The sensor detects vibrations of the tympanic membrane and transforms the vibrations into electrical signals that are processed by the sound processor. The processor transduces these signals via piezoelectric transduction, as opposed to the electromagnetic transduction used in the semi-implantable devices. A piezoelectric transducer (the sensor) is placed at the head of the incus and converts mechanical vibrations detected from the tympanic membrane into electrical signals delivered to the stapes by another piezoelectric transducer (the driver).

KEY POINTS:

This evidence review is updated regularly with searches of the MEDLINE database. The most recent literature review covers the period through December 13, 2023.

Summary of Evidence

For individuals who have hearing loss who receive semi-implantable or fully implantable middle ear hearing aids, the evidence includes the single-arm interventional studies submitted to the U.S. Food and Drug Administration, systematic reviews, and a number of observational series. Relevant outcomes include symptoms, functional outcomes, quality of life, and treatment-related morbidity. The data have suggested implantable middle ear hearing aids may provide some improvement in hearing compared with conventional external acoustic hearing aids in patients 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- and fully 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 patients have been included in the clinical trials, and with a median duration of follow-up less than 5 years. Studies of patients with conductive or mixed hearing loss and aural atresia, when external acoustic hearing aids are not an option, have also demonstrated a hearing benefit with semi-implantable middle ear hearing aids. However, these studies are few and limited to small numbers of patients. Therefore, conclusions on the safety and effectiveness of semi-implantable hearing aids are limited. 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 patients who are unable to use external air-conduction hearing aids. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Consensus Statement

An expert consensus statement on bone conduction devices and active middle ear implants in conductive and mixed hearing loss was published in 2022. The statement provides information about patient education and technical aspects of device placement, but does not provide clear recommendations regarding the patients who are most likely to benefit from implantable middle ear hearing aids over other devices.

The American Academy of Otolaryngology Head and Neck Surgery

The American Academy of Otolaryngology Head and Neck Surgery (2016) issued a position statement on implantable hearing devices, recently updated, which stated:

“The American Academy of Otolaryngology-Head and Neck Surgery considers active middle ear implants as appropriate treatment for adults with moderate to severe hearing loss when performed by a qualified otolaryngologist-head and neck surgeon. Based on available literature demonstrating that clinically selected adults receive substantial benefit, implanting active middle ear implants is accepted medical practice in those who benefit from amplification but are unable to benefit from the amplification provided by conventional hearing aids. Use of active middle ear implants, which have been U.S. Food and Drug Administration approved for these indications, should adhere to the restrictions and guidelines specified by the appropriate governing agency….”

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY WORDS:

Sensorineural hearing loss, semi-implantable middle ear hearing aid, acoustic hearing aid, Vibrant Soundbridge, SOUNDTEC Direct System, Esteem, Esteem implantable hearing system, Carina Fully Implantable Hearing Device , Maxum System(Ototronix)

APPROVED BY GOVERNING BODIES:

Two semi-implantable devices were approved by the FDA through the premarket approval process: the Vibrant Soundbridge (MED-EL Corp.) in 2000 and the Direct System™ (Soundtec) in 2001. The Soundtec System was discontinued by the manufacturer Ototronix in 2004 due to performance issues; it was re-released in 2009 under the name Maxum System. Approved FDA labeling for both states that the devices are “… intended for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid.”

In 2010, the Esteem Implantable Hearing System (Envoy Medical, St. Paul, MN), a fully implantable middle ear hearing aid, was approved by the FDA through the premarket approval process. FDA-approved labeling for the Esteem hearing implant indicates it is “intended to alleviate hearing loss... in adults 18 years of age or older with stable bilateral sensorineural hearing loss.”

Another fully implantable middle ear hearing aid, the Carina^® Fully Implantable Hearing Device, is in development (Otologics, now Cochlear), but does not have FDA approval. Phase 1 and 2 trials have been conducted in the United States under investigational device exemptions.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT codes:   

HCPCS codes:

REFERENCES:

1. American Academy of Otolaryngology - Head and Neck Surgery. Implantable Hearing Devices. 2013; www.entnet.org/?q=node/932.
2. American Academy of Otolaryngology - Head and Neck Surgery. Position Statement: Active Middle Ear Implants. 2016; www.entnet.org/resource/position-statement-active-middle-earimplants/#:~:text=The%20American%20Academy%20of%20Otolaryngology,otolaryngologist%2Dhead%20and%20neck%20surgeon.
3. Atas A, Tutar H, Gunduz B, et al. Vibrant SoundBridge application to middle ear windows versus conventional hearing aids: a comparative study based on international outcome inventory for hearing aids. Eur Arch Otorhinolaryngol. Jan 2014; 271(1):35-40.
4. Barbara M, Volpini L, Monini S. Delayed facial nerve palsy after surgery for the Esteem(®) fully implantable middle ear hearing device. Acta Otolaryngol. Apr 2014; 134(4):429-432.
5. Barbara M, Biagini M, Monini S. The totally implantable middle ear device 'Esteem' for rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol Apr 2011; 131(4):399-404.
6. Bernardeschi D, Hoffman C, Benchaa T et al. Functional results of Vibrant Soundbridge middle ear implants in conductive and mixed hearing losses. Audiol Neurootol 2011; 16(6):381-7.
7. Bruchhage KL, Lupatsii M, Möllenkolk F, et al. Hearing rehabilitation and microbial shift after middle ear surgery with Vibrant Soundbridge in patients with chronic otitis media. Eur Arch Otorhinolaryngol. Jul 2023; 280(7): 3107-3118.
8. 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. Apr 2017; 274(4): 1797-1806.
9. Butler CL, Thavaneswaran P, Lee IH. Efficacy of the active middle-ear implant in patients with sensorineural hearing loss. J Laryngol Otol. Jul 2013; 127 Suppl 2:S8-16.
10. Cadre B, Simon F, Célérier C, et al. Long-term outcomes of retrospective case series of middle ear implantation with Vibrant Soundbridge in children with congenital aural atresia. Eur Arch Otorhinolaryngol. Apr 2023; 280(4): 1629-1637.
11. Colletti L, Carner M, Mandala M et al. The floating mass transducer for external auditory canal and middle ear malformations. Otol Neurotol Jan 2011; 32(1):108-15.
12. Colletti L, Mandala M, Colletti V. Long-term outcome of round window Vibrant SoundBridge implantation in extensive ossicular chain defects. Otolaryngol Head Neck Surg Jul 2013; 149(1):134-41.
13. Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss. Otol Neurotol. Jun 01 2022; 43(5): 513-529.
14. de Abajo J, Sanhueza I, Giron L, et al. Experience with the active middle ear implant in patients with moderate-to-severe mixed hearing loss: indications and results. Otol Neurotol. Oct 2013; 34(8):1373-1379.
15. Dillon MT, Tubbs RS, Adunka MC, et al. Round window stimulation for conductive and mixed hearing loss. Otol Neurotol. Oct 2014; 35(9):1601-1608.
16. Ernst A, Todt I, Wagner J. Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: A systematic review. Laryngoscope. Jun 2016; 126(6):1451-1457.
17. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Esteem Implantable Hearing System. 2010; www.accessdata.fda.gov/cdrh_docs/pdf9/P090018b.pdf.
18. Frenzel H, Sprinzl G, Streitberger C, et al. The Vibrant Soundbridge in children and adolescents: preliminary European multicenter results. Otol Neurotol. Aug 2015; 36(7):1216-1222.
19. Gantner S, Epp A, Pollotzek M, et al. Long-term results and quality of life after vibrant soundbridge implantation (VSBs) in children and adults with aural atresia. Eur Arch Otorhinolaryngol. Jan 2024; 281(1): 129-139.
20. Gerard JM, Thill MP, Chantrain G et al. Esteem 2 middle ear implant: our experience. Audiol Neurootol 2012; 17(4):267-74.
21. 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 Dec 2012; 132(12):1306-10.
22. Hough JV, Matthews P, Wood MW, et al. Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial. Otol Neurotol. Nov 2002; 23(6): 895-903.
23. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
24. 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. Aug 2014; 35(7):1228-1237.
25. 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 Jun 2012; 37(3):240-4.
26. 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 Aug 2012; 33(6):916-21.
27. Kraus EM, Shohet JA, Catalano PJ. Envoy Esteem Totally Implantable Hearing System: phase 2 trial, 1-year hearing results. Otolaryngol Head Neck Surg Jul 2011; 145(1):100-9.
28. 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 Oct 2011; 32(8):1250-5.
29. 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 Apr 2013; 52(4):209-18.
30. 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 Jul 2013; 270(7): 2027-33.
31. 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.
32. Rahne T, Skarzynski PH, Hagen R, et al. A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers. Eur Arch Otorhinolaryngol. Jan 2021; 278(1): 67- 75.
33. Roman S, Denoyelle F, Farinetti A et al. Middle ear implant in conductive and mixed congenital hearing loss in children. Int J Pediatr Otorhinolaryngol Dec 2012; 76(12):1775-8.
34. 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. Apr 2016; 130(4):340-343.
35. Seebacher J, Weichbold V, Schorg P, et al. Subjective Hearing Impression and Quality of Life in Patients With Bilateral Active Middle Ear Implants. Otol Neurotol. Jul 2020; 41(6): e641-e647.
36. Shohet J, Gende D, Tanita C.  Totally Implantable Active Middle Ear Implant: Hearing and Safety Results in a Large Series. Laryngoscope, 2018.
37. Shohet J, Gende D, Bibee J, Patzkowski G, Tanita C. Speech Perception Gap Is Predictive of an Active Middle Ear Implant Advantage. Otol Neurotol, 2020. Vol. 41.
38. 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. Mar 2014; 271(3):477-482.
39. Song CI, Cho HH, Choi BY, et al. Results of Active Middle Ear Implantation in Patients With Mixed Hearing Loss After MiddleEar Surgery: A Prospective Multicenter Study (the ROMEO Study). Clin Exp Otorhinolaryngol. Feb 2022; 15(1): 69-76.
40. Sziklai I, Szilvassy J. Functional gain and speech understanding obtained by Vibrant Soundbridge or by open-fit hearing aid. Acta Otolaryngol Apr 2011; 131(4):428-33.
41. Tsang WS, Yu JK, Wong TK et al. Vibrant Soundbridge system: application of the stapes coupling technique. J Laryngol Otol Jan 2013; 127(1):58-62.
42. 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):1369-75.
43. 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.
44. Vyskocil E, Riss D, Honeder C et al. Vibroplasty in mixed and conductive hearing loss: Comparison of different coupling methods. Laryngoscope Jun 2014; 124(6): 1436-43.
45. Zernotti ME, Arauz SL, Di Gregorio MF et al. Vibrant Soundbridge in congenital osseous atresia: multicenter study of 12 patients with osseous atresia. Acta Otolaryngol Jun 2013; 133(6):569-73.
46. Zwartenkot JW, Hashemi J, Cremers CW et al. Active middle ear implantation for patients with sensorineural hearing loss and external otitis: long-term outcome in patient satisfaction. Otol Neurotol Jul 2013; 34(5):855-61.
47. Zwartenkot JW, Mulder JJ, Snik AF et al. Vibrant Soundbridge surgery in patients with severe external otitis: complications of a transcanal approach. Otol Neurotol 2011 Apr; 32(3):398-402.
48. Zwartenkot JW, Mulder JJ, Snik AF, et al. Active Middle Ear Implantation: Long-term Medical and Technical Follow-up, Implant Survival, and Complications. Otol Neurotol. Jun 2016; 37(5):513-519.

POLICY HISTORY:

Medical Policy Group, June 2004 (1)

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, June 2006 (1)

Medical Policy Group, June 2008 (1)

Medical Policy Group, June 2010 (1):  Key points updated

Medical Policy Group, December 2010 (1): Description, Key Points and reference list updated, added coverage for the Implantable middle ear device

Medical Policy Administration Committee, December 2010

Available for comment December 10, 2010 through January 24, 2011

Medical Policy Group, April 2011 (3): Added FDA approval for Esteem under Approved by Governing Bodies; Updated Codes

Medical Policy Group, September 2012: Updated Description, Key Points and References

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (3):  2013 & 2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (6):  Updates to Key Points, Key Words, Approved by Governing Bodies, Coding and References; no change to policy statement

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (6): Updates to Description, Policy Statement, Key Points, Key Words, and References; policy statement updated to remove coverage of fully implantable middle ear hearing aids.

Medical Policy Administration Committee March 2016

Available for comment February 26 through April 10, 2016

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Description, Key Points, Key Words, Governing Bodies and References. No change to policy intent.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points, Governing Bodies and References. Policy title edited to say “Semi-Implantable and Fully Implantable Middle Ear Hearing Aids”. No change to policy intent.

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (6): Updates to Key Points.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points and Governing Bodies.

Medical Policy Panel, February 2021

Medical Policy Group, March 2021 (3): 2021 Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Group, July 2021 (3): Minor Updates. Added References: Shohet J, Gende D, Tanita C. Totally Implantable Active Middle Ear Implant: Hearing and Safety Results in a Large Series. And Shohet J, Gende D, Bibee J, Patzkowski G, Tanita C. Speech Perception Gap Is Predictive of an Active Middle Ear Implant Advantage.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (3): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (6): Updates to Key Points, Benefit Application and References.

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9): Updates to Key Points, Key Words, Approved by Governing Bodies, Benefit Application and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.