BlueCross and BlueShield of Montana Medical Policy/Codes
Semi-Implantable and Fully Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss
Chapter: Durable Medical Equipment
Current Effective Date: November 26, 2013
Original Effective Date: November 07, 2008
Publish Date: November 26, 2013
Revised Dates: July 19, 2012; October 29, 2013
Description

Patients with moderate to severe sensorineural hearing loss are typically fit with external acoustic hearing aids.  However, these hearing aids may not be acceptable to patients, due to:

  • Issues related to anatomic fit,
  • Sound quality, or
  • Personal preference.

Semi-implantable and fully implantable middle ear hearing aids have been developed as an alternative to external acoustic hearing aids.

Semi-implantable devices

Two semi-implantable devices received U.S. Food and Drug Administration (FDA) approval; the Vibrant® Soundbridge™, approved in August 2000, and the Soundtec® Direct System™, approved in September 2001.  The Soundtec was subsequently discontinued by the manufacturer. The FDA label for both devices states that they 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."

The devices consist of three components:

  • Magnetic component (implanted onto the ossicles of the middle ear),
  • Receiver, and
  • Sound processor.

The Soundbridge device is implanted subcutaneously behind the ear, while the Soundtec device is placed in the ear canal.  The Soundbridge device processor is worn externally on the scalp over the receiver unit and held in place by a magnet.  The Soundtec device processor rests over the external ear.  The sound processor receives and amplifies the sound vibrations and transforms the sound pressure into electrical signals that are 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 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.

In the Soundbridge, the 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 Soundtec device was placed in the user’s ear canal while the processor would rest over the external ear.  In general, for both semi-implantable devices, the sound processor receives and amplifies the sound vibrations and transforms the sound pressure into electrical signals that are 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 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.

Fully Implantable Devices

The Esteem® Implantable Hearing System by Envoy Medical Corporation is a fully implantable middle ear hearing aid that received FDA approval in March 2010.  The 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.”  This device uses 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 to electrical signals that are delivered to the stapes by another piezoelectric transducer, the driver.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Semi-implantable middle ear hearing aids (e.g., Vibrant Soundbridge and Soundtec Direct System) may be considered medically necessary for patients with moderate to severe sensorineural bilateral hearing loss who are unable to use a standard hearing aid device because of at least one of the following anatomic criteria or medical conditions:

  • Congenital or surgically-induced malformations (e.g., atresia) of  the external ear canal or middle ear; OR
  • Chronic external otitis or otitis media; OR
  • Tumors of the external canal and/or tympanic cavity; OR
  • Dermatitis of the external canal.

Semi-implantable middle ear hearing aids for all other indications are considered experimental, investigational and unproven.

Upgrades of existing components may be considered medically necessary only for patients in whom response to existing components is inadequate to the point of interfering with the activities of daily living, or when components are no longer functional.

Fully implantable middle ear hearing aids (e.g., Esteem®) are considered experimental, investigational and unproven for all indications.

Note:  Benefit/contractual restrictions or exclusions for hearing aids would apply to this technology.

Rationale

FDA approval of the Soundbridge and Soundtec devices was based in part on clinical trials of 53 and 108 respective patients who had moderate to severe sensorineural hearing loss and who were dissatisfied with their existing external acoustic hearing aid.  Results of these trials are available in the FDA Summaries of Safety and Effectiveness.  The results of the Soundbridge and Soundtec trials have also been reported in the peer-reviewed published literature.  The principal outcome measures were the audiologic outcomes before (with the hearing aid in use) and after the implant.

The following audiologic outcomes were reported:

Functional Gain

Functional gain is defined as the difference in sound field threshold (measured in decibels) and is an indicator of functional benefit from an amplification device.  For the Soundbridge device the improvement in functional gain was 14.1 dB (decibels), while for the Soundtec device it was 7.9 dB, both considered a modest improvement.  The clinical significance of this improvement is difficult to determine.  For example, this level of improvement may be more clinically significant in patients with moderate hearing loss, for whom a 14 dB improvement in threshold might move them into the normal range for the spoken voice.

Speech Recognition

Speech recognition is assessed using the Speech Perception in Noise (SPIN) test and  Northwestern University-6 test (NU-6), which consists of a 50-item word list.  For the Soundbridge device no significant difference in word recognition was found in quiet or noisy conditions between the implant and acoustic hearing aid.  For the Soundtec device, a statistically significant improvement was noted in results of the NU-6 and SPIN test at 52 weeks compared to an optimally fitted hearing aid.  However, only 12 patients had completed the 52-week follow-up.

Patient Assessments

Patient self-evaluation was performed in a variety of ways.  The Profile of Hearing Aid Performance (PHAP) consists of seven subscales that measure several dimensions of hearing aid effectiveness, such as ease of communications, reverberation, distortion of sound, etc.  The Hearing Device Satisfaction Scale (HDSS) was developed by Symphonix, the manufacturer.  This scale evaluated hearing aid and Soundbridge use and the general satisfaction level.  The number of subjects who reported improvement was significant across all seven subscales of the PHAP.  The largest improvements in the Soundbridge compared to the acoustic hearing aid were reported for reverberation, reduced cues, and background noise.  Based on the HDSS, 94% reported improved overall sound quality for the Soundbridge.  For the Soundtec device, patient satisfaction was based on the Hough Ear Institute Profile.  This profile assesses patient preference, acoustic feedback, perception of speech quality, occlusion, and tinnitus.  At 20 weeks post-implant, improvements in all of the parameters were clinically significant.  For example, 89% of patients preferred the implantable hearing aid to the acoustic hearing aid, although this result is not surprising since only patients who were dissatisfied with their previous acoustic hearing participated in the trial.  A total of 67% of patients reported feedback with their previous acoustic hearing aid, while only 9% reported feedback with the implanted device.

Safety

Minimal safety issues appeared associated with either device.  In the Soundbridge device, the most common complication was a fullness sensation in 18, which did not resolve in 13.  Altered taste sensation was reported in seven, and transient pain in 13.  Two patients reported a reduction in residual hearing.  In the Soundtec device, the most common complication included device noise, ear pain, ear irritation, and processor failure.  These complications resolved in almost all patients; no patient requested removal of the device.  However, risks can only be adequately evaluated in broader populations over time.

Results of a Phase II trial of the SoundTec system were published, but this publication lags behind the data included in the FDA summary of safety and effectiveness.  An additional case series of 64 SoundTec implants was published in 2005.  The average functional gain varied with frequency, with the lowest functional gain in the lower speech frequencies (7.9 dB), with increasing functional gain at higher frequencies, ranging up to 27 dB at the highest frequency of 6,000 Hz.  The functional gain of 7.9 dB at the speech frequencies is similar to that reported in the FDA summary of safety and effectiveness, while it is markedly higher in the higher frequencies.  The cause of this marked discrepancy is not apparent.  In this case series, the authors also reported that a high percentage of patients were hearing the magnet move inside the ear, resulting in a refinement of the surgical procedure to better stabilize the magnet. 

Summary

Data suggests semi-implantable middle ear hearing aids may provide a marginal improvement in hearing compared to conventional external acoustic hearing aids.  The clinical significance of the improvement in functional gain and speech perception is uncertain, although a clear patient preference appears to be for the implantable devices.  However, the semi-implantable middle ear hearing aid does offer clinically significant benefit to adult patients who have moderate to severe sensorineural hearing loss and are unable to wear a conventional external hearing aid due to anatomic or medical conditions.  Review of scientific literature through July 2007 did not reveal any additional published data that would prompt reconsideration of the coverage statement.

2009 Update

Two small studies from Italy (n=12) and France (n=6) report early results of coupling the Vibrant Soundbridge system to the cochlea round window for patients with mixed hearing loss and the Vibrant Soundbridge versus conventional hearing aid in sensorineural high-frequency hearing loss.

A search of peer reviewed literature through November 2009 identified no significant publications that would change the coverage position of this medical policy. 

2012 Update

The policy was updated with a literature search through February 2012.

Semi-Implantable Hearing Aid

The literature review identified a systematic review by Tysome and colleagues that examined 17 studies (out of 644 articles identified) comparing hearing improvements in middle-ear hearing implants to conventional hearing aids.  The authors noted high-quality, long-term studies are not available.  However, they concluded there was sufficient evidence to support the use of middle-ear hearing aid implants.  They noted hearing gains with middle-ear hearing aid implants were comparable to conventional hearing aids and may even improve sound quality and speech perception.

Fully Implantable Hearing Aid

A search of the MEDLINE database identified only three published reports on use of a totally implantable hearing device.  Barbara and colleagues reported on use of the 2010 FDA-approved totally implantable Esteem device in 21 patients with severe bilateral sensorineural hearing loss.  The authors reported mean hearing threshold levels improved overall from 70 to 48 db.  In another article reporting on six patients implanted with the Esteem device, Barbara et al. found the device improved hearing when assessed during postoperative fittings. Chen and colleagues reported on the Phase I results of the Envoy Totally Implantable Hearing System in seven patients followed up at two and four months after activation of the device.  Improvements in word recognition and communication in background noise over best-fit hearing aid usage was perceived in five patients. Patient outcomes in functional gain and speech reception thresholds were comparable to best-fit hearing aid usage.  These publications report on short-term results from a small number of patients and overall, demonstrate insufficient evidence.

The FDA approval of the Esteem device was based on a prospective, nonrandomized, multicenter clinical trial of 60 patients with moderate to severe sensorineural hearing loss designed to assess the safety and efficacy of the Esteem Hearing System.  Patients served as both control and test subject as hearing was tested before (with and without hearing assistive devices) and after Esteem implantation.  Results of this trial are available in the FDA Summaries of Safety and Effectiveness. In this study, patients experienced an improvement of 11.4dB in mean speech reception threshold at ten months’ post-implantation when compared to pre-implant aided speech reception thresholds. Overall, word recognition scores were equal to or better than pre-implant aided scores in 93% of patients. The other 7% experienced lower word recognition scores than pre-implant scores using hearing aids.  Ninety-six adverse device events occurred and were considered to be not serious. Taste disturbance was reported to be the most common side effect reported at 42% followed by tinnitus in 18% and facial paralysis/paresis in 7% of patients. Severe adverse device effects were experienced in 6 of the 57 patients implanted and included three revisions due to fibrous adhesions which limited implant benefit, one incision breakdown which required explantation, and one wound infection and one severe pain and facial weakness case both of which resolved when treated with medication. Overall, 70% of all adverse events resolved at ten-month follow-up. However, the serious adverse event of facial paralysis/palsy had not resolved in two patients.

Ongoing Trials

The Envoy Medical Corporation continues to study the Esteem Totally Implantable Hearing System in the 57 patients in the PMA clinical trial reported to the FDA.  The study will further evaluate the long-term (five years) hearing outcomes of speech reception threshold and word recognition score along with adverse events (NCT01092910 on ClinicalTrials.gov). The trial is expected to be completed in 2015.  Per agreement with the FDA, Envoy will also conduct a new prospective, multi-center, non-randomized, audiologist-blinded, 1-arm observational study of 120 patients. This study will address safety at one month by evaluating the incidence of facial paresis/paralyses and effectiveness at five years by evaluating speech reception threshold and word recognition score.

The available evidence for use of fully implantable middle ear hearing aids is preliminary and thus insufficient to demonstrate long-term improvement in net health outcome. Concerns exist about adverse events with these devices.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

20.99, 389.10, 389.11, 389.12, 389.14, 389.18

ICD-10 Codes

H90.3, H90.41-H90.42, H90.5, 09HD0SY, 09HE0SY

Procedural Codes: 69799, S2230, V5095
References
  1. Vibrant Soundbridge.  FDA Summary of Safety and Effectiveness: Available at www.fda.gov .
  2. Soundtec Direct System.  FDA Summary of Safety and Effectiveness:  Available at www.fda.gov .
  3. Luetje, C.M.,  Brackman, D., et al.  Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study.  Otolaryngology Head and Neck Surgery, (2002) 126(2):97-107.
  4. Todt, I., Seidl, R.O., et al.  Comparison of different vibrant Soundbridge audio processors with conventional hearing AIDS.  Otolaryngology Neurotology (2002 September) 23(5):669-73.
  5. Sterkers, O., Boucarra, D., et al.  A middle ear implant, the Symphonix Vibrant Soundbridge: retrospective study of the first 125 patients implanted in France.  Otolaryngology  Neurotology (2003) 24(3):27-36.
  6. Hough, J.V., Matthews, P., et al.  Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial.  Otolaryngology Neurotology (2002) 23(6):895-903.
  7. Silverstein, H., Atkins, J., et al.  Experience with the SOUNDTEC Implantable hearing aid. Otolaryngology Neurotology (2005) 26(2):211-7.
  8. Venail F, Lavieille JP, Meller R et al. New perspectives for middle ear implants: first results in otosclerosis with mixed hearing loss. Laryngoscope 2007; 117:552-5. 
  9. Beltrame AM, Martini A, Prosser S et al. Coupling the Vibrant Soundbridge to cochlea round window: auditory results in patients with mixed hearing loss. Otol Neurotol 2009; 30(2):194-201.
  10. Truy E, Philibert B, Vesson JF et al. Vibrant soundbridge versus conventional hearing aid in
  11. sensorineural high-frequency hearing loss: a prospective study. Otol Neurotol 2008; 29(5):684-7.
  12. 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):684-7.
  13. 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.
  14. Barbara M, Biagini M, Monini S. The totally implantable middle ear device 'Esteem' for rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol. 2011; 131(4):399-404 .
  15. Barbara M, Manni V, Monini S. Totally implantable middle ear device for rehabilitation of sensorineural hearing loss: preliminary experience with the Esteem, Envoy. Acta Otolaryngol 2009; 129(4):429-32.
  16. Chen DA, Backous DD, Arriaga MA et al. Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss. Otolaryngol Head Neck Surg 2004; 131(6):904-16.
  17. Esteem Implantable Hearing System. FDA Summary of Safety and Effectiveness: http://www.accessdata.fda.gov.
  18. Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (April 2012) Surgery 7.01.84.
History
July 2012  Policy updated with literature review, reference numbers 10-14 added, “fully implantable” hearing aid added to policy, title changed to reflect addition, fully implantable device considered investigational.
November 2013 Policy formatting and language revised.  Title changed from "Hearing Aid-Semi-Implantable and Fully Implantable Middle Ear Hearing Aids" to "Semi-Implantable and Fully Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss".  Policy statement changed from strictly investigational to having medically necessary criteria for semi-implantable hearing aids.
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Semi-Implantable and Fully Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss