Archived Policies - Surgery
Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss
Semi-implantable middle ear hearing aids (i.e., 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:
Semi-implantable middle ear hearing aids for all other indications are considered experimental, investigational and unproven.
Note: Benefit/contractual restrictions or exclusions for hearing aids would apply to this technology.
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:
A semi-implantable middle ear hearing aid has been developed as an alternative to external acoustic hearing aids. Two such devices have received U.S. Food and Drug Administration (FDA) approval; the Vibrant Soundbridge approved in August of 2000, and the Soundtec Direct system approved in September 2001. 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:
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.
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 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 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 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.
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.
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.
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.
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.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
Vibrant Soundbridge. FDA Summary of Safety and Effectiveness: Available at <www.fda.gov>.
Soundtec Direct System. FDA Summary of Safety and Effectiveness: Available at <www.fda.gov>.
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.
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.
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.
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.
Silverstein, H., Atkins, J., et al. Experience with the SOUNDTEC Implantable hearing aid. Otolaryngology Neurotology (2005) 26(2):211-7.
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.
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.
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.
Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (November 2009) Surgery 7.01.84.
3/1/2010 Revised/updated entire document, conditional coverage position unchanged.
10/1/2007 Revised/Updated Entire Document
7/1/2004 New Medical Document
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