Archived Policies - Surgery


Semi-Implantable and Fully Implantable Middle Ear Hearing Aids

Number:SUR714.008

Effective Date:04-15-2015

End Date:06-30-2016

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/or 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/or unproven for all indications.

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

Description:

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 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).

Sound amplification through the use of an air-conduction 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. However, these hearing aids may not be acceptable to patients, either due to issues related to anatomic fit, sound quality, or personal preference. Conductive hearing loss may be treated with acoustic or bone conduction hearing aids when surgical or medical interventions are unable to correct hearing loss. Semi-implantable and fully implantable middle ear hearing aids have been developed as an alternative to external acoustic hearing aids.

Regulatory Status

Two semi-implantable devices received approval by U.S Food and Drug Administration (FDA), the Vibrant® Soundbridge™, approved in August 2000, and the Soundtec® Direct System™, approved in September 2001. The Soundtec was discontinued by the manufacturer Ototronix LLC in 2004 due to performance issues; it was rereleased in 2009 under the name Maxum™ System. The FDA labeling approved 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 3 components: a magnetic component 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 Soundtec (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 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 (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. FDA product code: MPV.

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. FDA product code: OAF.

An additional fully-implantable middle ear hearing aid, the Carina® Fully Implantable Hearing Device was under development (Otologics, Inc., Boulder, CO), but does not have FDA approval.

Rationale:

This policy was originally developed in 2004 and has been updated with searches of scientific literature through February 2015. This section of the current policy has been substantially revised. The following is a summary of the key literature to date.

Semi-Implantable Hearing Aids

Clinical Trials for FDA-Approval of Semi-Implantable Middle Ear Hearing Aids

U.S Food and Drug Administration (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. (2, 3) The results of the Soundbridge and Soundtec trials have also been reported in the peer-reviewed published literature. (4) 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 [dB]) and is an indicator of functional benefit from an amplification device. For the Soundbridge device, the improvement in functional gain was 14.1 dB, while for the Soundtec device, it was 7.9 dB; both are 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 Speech Perception in Noise (SPIN) test and the Northwestern University?6 (NU-6) test, 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 with 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 7 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 7 subscales of the PHAP. The largest improvements in the Soundbridge compared with 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 postimplant, improvements in all of the parameters were clinically significant. For example, 89% of patients preferred the implantable hearing aid to the acoustic hearing aid. A total of 67% of patients reported feedback with their previous acoustic hearing aid, while only 9% reported feedback with the implanted device. The clinical significance of the improvement in functional gain and speech perception is uncertain, although there appears to be a clear patient preference for the implantable devices. (5)

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 7 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.

Additional Studies for Semi-Implantable Middle Ear Hearing Aids

A systematic review by Tysome et al, in 2010, examined 17 studies (of 644 articles identified) comparing hearing improvements in middle-ear hearing implants with conventional hearing aids. (6) 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 with gains with conventional hearing aids and may even improve sound quality and speech perception. Furthermore, they noted the evidence did not demonstrate a decrease in residual hearing.

In 2013, Butler et al published results of a systematic review of comparative studies evaluating partially and fully implantable middle ear hearing devices for sensorineural hearing loss. (7) 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 of functional hearing gain, 1 found that middle ear implants were significantly better than hearing aids, 1 found that hearing aids were 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 conclude that middle ear implants appear to be at least as effective as hearing aids in improving hearing outcomes.

Results of a 2002 phase 2 trial of the Soundtec system were published, (8) but this publication lags behind the data included in the FDA summary of safety and effectiveness. (3) An additional case series of 64 SoundTec implants was published in 2005. (9) 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 6000 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.

Truy et al reported on the Vibrant Soundbridge versus conventional hearing aids in 6 patients with sensorineural high-frequency hearing loss and found some improvements in hearing with the Soundbridge system. (10)

Small studies report early results of coupling the Vibrant Soundbridge system to the cochlea round window for patients with mixed hearing loss (11, 12) and for conductive and mixed hearing loss, (13) sloping high-frequency sensorineural hearing loss, (14) and aural atresia. (15-18)

Semi-Implantable Middle Ear Hearing Aids for Conductive or Mixed Hearing Loss

While the Vibrant Soundbridge received FDA approval for sensorineural hearing loss, several studies have evaluated it for off-label use in conductive or mixed hearing loss with coupling of the devices floating mass transducer to the middle ear’s round or oval window.

Marino et al reported results of round window-coupled Vibrant Soundbridge implantation in 18 subjects with conductive or mixed hearing loss who could not derive benefit from conventional hearing aids due to chronic otitis externa, blind sac closure, pain with hearing aid mold use, and severe to profound mixed hearing loss.(19) Speech recognition in quiet settings with the Soundbridge device was similar to conventional hearing aids, while speech recognition in noisy settings was improved with the Soundbridge device. However, these studies are small (range, 5-25 patients) and report only short-term follow up and should be considered preliminary.

Colletti et al reported longer term outcomes for a case series of 50 patients aged 2 months to 74 years with severe conductive or mixed hearing loss due to ossicular chain defects who underwent coupling of the Vibrant Soundbridge system to the round window. (20) Although subjects demonstrated improvements in speech perception and pure-tone audiometry (in adults) and auditory brainstem response thresholds (in infants), the study’s implications for practice are limited due to a large number of subjects with missing data (17/50) and a lack of comparison with other therapies.

Vyskocil et al retrospectively compared hearing outcomes for 9 patients who received the Vibrant Soundbridge device with a modified coupling method (attachment of the floating mass transducer to the stapes/oval window, round window, or a drilled promontory bone) with 9 patients who received standard vibroplasty with the Vibrant Soundbridge device among patients with mixed and conductive hearing loss. (21) The authors reported similar hearing improvements in both groups.

Atas et al compared quality-of-life and patient satisfaction outcomes after Vibrant Soundbridge implantation with oval or round window coupling in 19 patients with mixed or conductive hearing loss. (22) Patients were surveyed preoperatively after at least 3 months of conventional hearing aid use and postoperatively after 3 months of Vibrant Soundbridge use with the International Outcome Inventory for Hearing Aids (IOI-HA). The total IOI-HA score was higher with the Soundbridge than with conventional hearing aids (28.5 vs 25.5; P=0.018).

Skarzanski et al retrospectively evaluated outcomes after Vibrant Soundbridge implantation using a surgical technique involving direct round window coupling with no interposed fascia among 21 adult patients with mixed or conductive hearing loss. (23) Over 3 years of follow-up, bone conduction hearing thresholds were stable. There were no cases of device extrusion or significant complications; 19% of patients had tinnitus, which resolved within 2 months post-operatively. In another series, Dillon et al evaluated outcomes after Vibrant Soundbridge implantation using round window coupling for 18 subjects with conductive or mixed hearing loss. (24) All subjects experienced a significant improvement in aided speech perception abilities compared with preoperative performance, but 6 developed perioperative complications, 4 of which required medical management or evaluation. De Abajo et al also reported aided speech perception abilities post-Soundbridge implantation among 13 subjects with moderate-to-severe mixed hearing loss. (25)

Semi-Implantable Middle Ear Hearing Aids with Alternative Surgical Approaches

Studies from European centers reported early results of combining the Soundbridge system with stapes surgery for otosclerosis. For example, in 2007, Venail et al report on results of using this combined approach in 4 patients. (26) These results should be considered preliminary. In addition, in the United States, this use would not be consistent with the FDA-approved labeling.

Zwartenkot et al reported on a transcanal approach to implantation of the Vibrant Soundbridge in 13 adults with chronic external otitis and sensorineural hearing loss. (27) The authors reported the transcanal approach resulted in several postoperative complications over 51 months of follow-up including extrusion of the conducting wire into the ear canal in 5 cases. After repair of the wire extrusions, 3 cases experienced repeated extrusion. Therefore, the transcanal approach is not recommended for Soundbridge system implantation in patients with external otitis.

Subsequently, Zwartenkot et al reported longer term (mean, 7.5 years) follow-up outcomes for 33 patients with moderate to severe sensorineural hearing loss with severe chronic otitis externa who were implanted with the Vibrant Soundbridge system or the Otologics MET system, a middle ear implant system not available in the United States. (28) Compared with baseline, at long-term follow-up, subjects had statistically significant improvements in total scores on the Abbreviated Profile of Hearing Aid Benefit, but the magnitude of the difference was small (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. This study provides some evidence that middle ear implantable hearing aids have some benefit over the longer term for patients with chronic otitis externa.

Fully Implantable Hearing Aid

Clinical Trials for FDA Approval of a Fully Implantable Middle Ear Hearing Aid

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. (29) Patients served as both control and test subject as hearing was trial are available in the FDA Summaries of Safety and Effectiveness. In this study, patients experienced an improvement of 11.4 dB in mean speech reception threshold at 10 months’ postimplantation when compared with preimplant aided speech reception thresholds. Overall, word recognition scores were equal to or better than preimplant aided scores in 93% of patients. The other 7% experienced lower word recognition scores than preimplant 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 3 revisions due to fibrous adhesions which limited implant benefit, 1 incision breakdown which required explantation, and 1 wound infection and 1 severe pain and facial weakness case, both of which resolved when treated with medication. Overall, 70% of all adverse events resolved at 10-month follow-up. However, the serious adverse event of facial paralysis/palsy had not resolved in 2 patients.

Kraus et al reported on 1-year follow-up of the Esteem study in 2011. (30) Results were similar to those reported to the FDA at 10 months’ follow-up. Speech reception thresholds improved 11.8±1.8 dB from a mean preimplant aided score of 41.2 dB to 29.4 dB (p≤0.001). Word recognition scores improved by a mean of 19.8%±4.3% from preimplant aided scores. The authors reported 133 adverse events including 3 cases of facial paresis resolved with medication.

Additional Studies for a Fully Implantable Middle Ear Hearing Aid

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. (31) The review included 22 studies with a total of 244 patients, 110 implanted with the Carina device and 134 with the Esteem 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 the studies showed improvement of sound field threshold from unaided to aided conditions the fully implantable device, but the magnitude of the improvements varied.

A 2012 systematic review of literature on the Esteem device included 7 articles that met inclusion criteria. (32) Complication rates with the Esteem device most commonly included taste disturbance. Clinically significant improvements in functional gain, speech reception, and speech recognition over the unaided condition were reported. In studies comparing the Esteem implant with conventional hearing aids, findings were mixed. Improvements in functional gain were similar to those for hearing aids; however, speech recognition and quality of life were greater with the implants. This limited evidence suggests these devices may offer a relatively safe and effective treatment option, particularly for patients who are medically unable to wear conventional hearing aids.

Several representative case series are described below. Barbara et al reported on use of the 2010 FDA-approved totally implantable Esteem device in 21 patients with severe bilateral sensorineural hearing loss. (33) The authors reported mean hearing threshold levels improved overall from 70 to 48 dB. In another article reporting on 6 patients implanted with the Esteem device, Barbara et al found the device improved hearing when assessed during postoperative fittings. (34) Chen et al reported on the phase 1 results of the Envoy Totally Implantable Hearing System in 7 patients followed up at 2 and 4 months after activation of the device. (35) Improvements in word recognition and communication in background noise over best-fit hearing aid usage was perceived in 5 patients. Patient outcomes in functional gain and speech reception thresholds were comparable with best-fit hearing aid usage.

Several recent small case series (36-39) have been published that do not provide significant additional evidence about outcome improvements associated with the Esteem device.

A case series published since the Pulcherio et al and Klein et al 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 6/34 subjects (17.6%). (40)

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov on February 19, 2015, identified no ongoing randomized trials evaluating partially- or fully-implantable middle ear hearing aids.

Summary

The limited data suggest semi-implantable middle ear hearing aids may provide marginal improvement in hearing compared with conventional external acoustic hearing aids in patients with sensorineural hearing loss. Safety concerns appear to be minimal. However, a limited number of patients have been included in the clinical trials, and a limited number have completed more than 1 year of follow-up. Studies on patients 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. 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 available evidence for use of fully implantable middle ear hearing aids 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 experimental, investigational and/or unproven.

Practice Guidelines and Position Statements

The American Academy of Otolaryngology-Head and Neck Surgery issued a position statement on implantable hearing devices, most recently updated on January 8, 2013, which states: (41)

“The American Academy of Otolaryngology-Head and Neck Surgery, Inc. considers the implantation of a percutaneous of transcutaneous bone conduction hearing device, placement of a bone conduction oral appliance, and implantation of a semi-implantable or totally implantable hearing device to be acceptable procedures for the relief of hearing impairment when performed by, or in collaboration with, a qualified otolaryngologist-head and neck surgeon. Use of any device must adhere to the restrictions and guidelines specified by the appropriate governing agency, such as the Food and Drug Administration in the United States and other similar agencies in countries other than the United States.”

Contract:

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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

69799

HCPCS Codes

S2230, V5095

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

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.

References:

1. Ototronix. Important Safety Information. 2014; http://www.ototronix.com/. Accessed January 14, 2015.

2. Vibrant Soundbridge. FDA Summary of Safety and Effectiveness. http://www.accessdata.fda.gov. Accessed January 14, 2015.

3. Soundtec Direct System. FDA Summary of Safety and Effectiveness. http://www.accessdata.fda.gov.. Accessed January 14, 2015.

4. 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. Feb 2002; 126(2):97-107. PMID 11870337

5. 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. May 2003; 24(3):427-436. PMID 12806295

6. 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. Dec 2010; 31(9):1369-1375. PMID 20479696

7. 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. PMID 23790515

8. 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. PMID 12438853

9. Silverstein H, Atkins J, Thompson JH, Jr., et al. Experience with the SOUNDTEC implantable hearing aid. Otol Neurotol. Mar 2005; 26(2):211-217. PMID 15793407

10. 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. Aug 2008; 29(5):684-687. PMID 18434928

11. 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. Feb 2009; 30(2):194-201. PMID 19180678

12. 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):1306-1310. PMID 23039370

13. 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):381-387. PMID 21228566

14. 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):428-433. PMID 21401449

15. 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):108-115. PMID 21131892

16. 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):1250-1255. PMID 21897320

17. 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):1775-1778. PMID 22985678

18. 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):569-573. PMID 23448351

19. 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):209-218. PMID 23527900

20. 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):134-141. PMID 23585147

21. Vyskocil E, Riss D, Honeder C, et al. Vibroplasty in mixed and conductive hearing loss: Comparison of different coupling methods. Laryngoscope. Oct 19 2013. PMID 24338550

22. 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. PMID 23400404

23. 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. PMID 23512431

24. 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. PMID 25111522

25. 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. PMID 24005166

26. Venail F, Lavieille JP, Meller R, et al. New perspectives for middle ear implants: first results in otosclerosis with mixed hearing loss. Laryngoscope. Mar 2007; 117(3):552-555. PMID 17334321

27. Zwartenkot JW, Mulder JJ, Snik AF, et al. Vibrant Soundbridge surgery in patients with severe external otitis: complications of a transcanal approach. Otol Neurotol. Apr 2011; 32(3):398-402. PMID 21307813

28. 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):855-861. PMID 23739560

29. Esteem Implantable Hearing System. FDA Summary of Safety and Effectiveness. http://www.accessdata.fda.gov. Accessed January 14, 2015.

30. 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):100-109. PMID 21493292

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. PMID 25329463

32. 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):916-921. PMID 22772013

33. 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. PMID 21198340

34. 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. Apr 2009; 129(4):429-432. PMID 19117172

35. 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. Dec 2004; 131(6):904-916. PMID 15577788

36. Gerard JM, Thill MP, Chantrain G, et al. Esteem 2 middle ear implant: our experience. Audiol Neurootol. 2012; 17(4):267-274. PMID 22627489

37. 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):240-244. PMID 22708943

38. 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. Nov 10 2012. PMID 23143506

39. 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. PMID 23218176

40. Barbara M, Volpini L, Monini S. Delayed facial nerve palsy after surgery for the Esteem (R) fully implantable middle ear hearing device. Acta Otolaryngol. Apr 2014; 134 (4):429-432. PMID 24433055

41. American Academy of Otolaryngology - Head and Neck Surgery. Implantable Hearing Devices. 2013; http://www.entnet.org. Accessed February 19, 2015.

42. Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2015 March) Surgery 7.01.84.

Policy History:

Date Reason
4/15/2015 Document updated with literature review. Coverage unchanged. Title changed from: Semi-Implantable and Fully Implantable Middle Ear Hearing Aids for Moderate to Severe Sensorineural Hearing Loss.
8/15/2012 Document updated with literature review. The following was added to coverage: Fully implantable middle ear hearing aids are considered experimental, investigational and unproven for all indications. Title was changed from: Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss to: Semi-Implantable and Fully Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss. CPT/HCPCS code(s) updated
3/1/2010 Revised/updated entire document, conditional coverage position unchanged.
10/1/2007 Revised/Updated Entire Document
7/1/2004 New Medical Document

Archived Document(s):

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