This document addresses the use of semi-implantable and fully implantable middle ear hearing aids for the treatment of moderate to severe sensorineural hearing loss.

Note: Benefit language supersedes this document. Hearing aids are not a covered benefit under all member contracts/certificates. Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these requirements or documents may specifically address the topic of hearing aids.

Note: Please see the following documents related to the treatment of hearing loss:

• SURG.00014 Cochlear Implants and Auditory Brainstem Implants
• SURG.00020 Bone-Anchored Hearing Aids

Investigational and Not Medically Necessary:

Semi-implantable and fully implantable middle ear hearing aids are considered investigational and not medically necessary for all indications.

Middle Ear Hearing Aids

Externally worn acoustic hearing aids are widely accepted for use by individuals with moderate to severe sensorineural hearing loss. Semi-implantable and fully implantable middle ear hearing aids have been proposed as an alternative to an externally worn acoustic hearing aid for select individuals with moderate to severe sensorineural hearing loss.

Semi-Implantable Middle Ear Hearing Aids

The efficacy of the semi-implantable middle ear hearing aid was studied by comparing the results of pre- and postimplant audiometric tests and audiologic questionnaires. Additional outcome measures included satisfaction of the subjects with fit and comfort and with the quality and clarity of sound. Individual preference for an implantable middle ear hearing aid compared to an externally worn hearing aid was considered, however, it must be determined to what extent individual preference is based on convenience compared to preference based on improved hearing.

In the early European trials of semi-implantable middle ear hearing aids, the studies included overlapping populations of subjects from many of the same institutions where each subject served as his or her own control. A feasibility study by Fisch and colleagues (2001) reported detailed steps of the implantation of the Vibrant^® Soundbridge™ (VSB) (Symphonix Devices, Inc., San Jose, CA) direct-drive middle ear hearing aid and evaluated the impact of surgery on residual hearing. Forty-seven subjects had successful implantation, however, the study did not report outcomes in detail, but suggested that implantation was feasible with relatively few surgical complications and little change in severity of hearing impairment. A subsequent multicenter study conducted by Fraysee and colleagues (2001) reported audiometric results for 25 subjects who underwent implantation at several French medical centers. The authors reported that the Soundbridge™ (model D) semi-implantable middle ear hearing aid provided "significantly superior" functional gain than conventional hearing aids. The VSB implantation procedure did not affect the residual hearing level in the implanted ear, nor did it present any unacceptable risk. The authors concluded that the measurable benefit from VSB in comparison with conventional amplification was demonstrated with regard to the provision of superior usable amplification and greater ease in communication in daily listening environments for the majority of subjects. However, they suggested "a longitudinal study beyond three months of the same 25 subjects may help to resolve some of the unanswered questions with regard to the long-term effects and benefits of the VSB for the adults with hearing impairments."

The U.S. Food and Drug Administration (FDA, 2000) premarket approval (PMA) of the Vibrant^® P/D Soundbridge™ Systems (VSB) was based in part on clinical trials of 53 and 103 participants respectively, who had bilateral moderate to severe sensorineural hearing loss and who were dissatisfied with their existing externally worn acoustic hearing aid. Results of these trials are available in the FDA Summary of Safety and Effectiveness and reported in the following peer-reviewed published literature. 

Luetje and colleagues (2002) conducted a multicenter, phase III, prospective, single-subject controlled clinical trial evaluating the safety and efficacy of the VSB implant for persons with moderate to severe sensorineural hearing loss. This was the only study of the VSB implant performed in U.S. medical centers; all 54 study subjects were currently using air conduction hearing aids for four hours per day for at least three months prior to evaluation for the implant. Principal audiologic outcome measures, before (with the hearing aid in use) and after the implant, were evaluated at four or more intervals, following the subjects through five months after implantation. Key outcomes were reported as functional gain, speech recognition, and subject self-evaluation of hearing aid effectiveness. While improvement in functional gain, defined as the difference in sound field threshold measured in decibels (dB), was considered modest at 14.1 dB, the majority of subjects (96%) were reported as experiencing a benefit as demonstrated by the lack of pure tone average (PTA) changes. No significant difference in word recognition was found in quiet or noisy conditions between the VSB implant and the acoustic hearing aid. The number of subjects with improvement in hearing effectiveness was reported as "significant" across all seven subscales of the Profile of Hearing Aid Performance (PHAP) test. The most significant subject-perceived improvements (n=50) when comparing the VSB implant to the baseline acoustic hearing aid were reported in background noise (53%), reverberation (48%), and reduced cues (39%). General satisfaction with improvement in the overall sound quality of the VSB implant was reported by 94% of the subjects. Limitations of the study include the lack of a randomized control group and subject self-evaluation of hearing effectiveness, in particular, using a satisfaction scale that was developed by the manufacturer.

In the clinical trial data reported to the FDA, implantation of the VSB resulted in complications among 81 subjects (n=5, feasibility study; n=54, effectiveness study (Luetje, 2002); n=22, supplemental safety cohort). The most frequently reported complications included sensation of fullness in the ear (n=18, 22%), transient pain (n=13, 16%), and altered taste sensation (n=7, 8.6%). The majority of the complications reported during the clinical trials were temporary. Failure of the implant occurred in six subjects (7%), requiring removal and reimplantation. All failures occurred with a version of the implant that is no longer produced by the manufacturer.

Following the FDA approval, additional data were obtained from subjects implanted with the VSB at 21 tertiary referral and teaching hospitals in France. Sterkers and colleagues (2003) performed a retrospective survey of audiological data and subjective data from self-assessment scales administered postoperatively to determine the degree of benefit and satisfaction in subjects implanted with the VSB. In the first 125 VSB-implanted subjects, no clinically significant change was observed for residual hearing postoperatively. Most subjects (83%) reported they were either satisfied or very satisfied with the VSB. Speech comprehension in quiet surroundings was reported as significantly improved for implanted subjects versus the preoperative unaided hearing condition. Data analyzed from this measurement, however, is limited in drawing conclusions as different speech test materials were used and analyzed for each of two small subgroups, 13 and 37 subjects, respectively. No correlation was observed between subjective reports of satisfaction postoperatively and performance on preoperative objective tests or subject characteristics. Additional limitations of this retrospective study include lack of a randomized control group and the single subject design where each participant served as his or her own control when reporting subjective data from self-assessment scales.

Schmuziger and colleagues (2006) assessed long-term results with the VSB implant analyzing pre- and post-operative results of audiologic tests. The small study (n=20) involved retrospective chart review with additional subject interview and audiologic testing. Fifteen subjects underwent audiologic testing at follow-up, including pure-tone and speech audiometry in silence and noise. The authors concluded that satisfaction with the VSB implant was not superior to conventional hearing aids in subjective and in audiometric terms.

There are minimal safety concerns related to externally worn hearing aids. In contrast, a semi-implantable middle ear hearing aid requires a surgical procedure for implantation. Potential risks cited for this implant include a decrease in residual hearing in the implanted ear and infection in the ear and adjacent structures. Major ear surgery may also result in numbness, swelling, or discomfort around the ear, the possibility of facial paresis, neck pain, and disturbance of balance and taste. Therefore, equivalency or improvement in audiologic outcomes associated with a semi-implantable hearing aid must be balanced against the potential risks inherent in a surgical procedure.

The evidence in the peer-reviewed literature regarding the efficacy and safety of the VSB is inconsistent and the FDA did not allow the manufacturer of the device (Symphonix Devices, Inc.) to claim superiority to standard hearing aids in product labeling indications. In the data that accompanied the clinical studies presented to the FDA, most subjects were satisfied or very satisfied with the VSB implant (83% to 98%) and 91% reported the device was beneficial. In one study (Snik, 2001), the expected hearing gains were not achieved in 52% of the subjects. In addition, while residual hearing was not affected in most subjects (90% to 96%), in one study residual hearing decreased in 13% of subjects (Luetje, 2002). Most of the study subjects preferred the VSB implant compared to the previously used conventional air conduction hearing aids; however, audiometric parameters such as functional gain and word recognition were not significantly improved for semi-implantable middle ears hearing aids compared to conventional hearing aids in all studies.

Additional peer-reviewed publications in the form of small case studies have evaluated the safety and effectiveness of the VSB implant in individuals with moderate-to-severe sensorineural hearing impairment who are unable to tolerate an externally worn air conduction hearing aid (i.e. ear mold) because of an anatomic or medical condition such as atresia of the external ear or severe chronic otitis externa. Kiefer and colleagues (2006) identified that congenital malformations of the auricle are often combined with atresia of the outer ear canal and malformations of the ossicles, resulting in aesthetic and functional defects. These investigators combined the reconstruction of the auricle with implantation of an active middle ear hearing aid in this single case study of an individual with bilateral ear microtia, fibrous atresia of the external ear canals and malformation of the ossicles due to Treacher Collins-Franceschetti syndrome. Functional results were reported as favorable, with aided thresholds between 15 and 30 dB in the frequency range of 0.75 to 6 kilohertz (kHz), mono-syllabic word understanding at 65 dB sound pressure level (SPL) increased from 0% to 80%. The authors concluded that the combined reconstruction and implantation procedure offered a promising approach to the treatment of congenital malformations of the auricle combined with atresia.

Verhagen and colleagues (2008) retrospectively compared aided speech recognition scores obtained at conversational level (65 dB) in individuals with the VSB implant (n=22), the Otologics Middle Ear Transducer (MET) (Otologics LLC, Boulder, CO) (n=10), conventional hearing aids (behind-the-ears) (n=47), and cochlear implants (CIs) (n=123). In relation to mild hearing loss, the authors concluded that individuals fitted with a VSB middle ear implant do not demonstrate better speech recognition scores than those fitted with conventional hearing aids.

Frenzel and colleagues (2009) prospectively analyzed a consecutive cohort of seven subjects (mean age, 15) with unilateral osseous aural atresia who underwent plastic auricular reconstruction and placement of a VSB implant. Outcome measurements included audiometric testing, including pure-tone thresholds, and speech testing in quiet and noise. The mean threshold with the VSB activated in the free field warble tone audiometry was 23.8 dB hearing level. Mean functional gain was 45.5 dB hearing level. Mean aided free field speech discrimination in quiet was 64% at 50 dB, 99% at 65 dB, and 100% at 80 dB. The authors concluded that VSB implantation was safe and effective and could be implemented in combination with outer ear reconstruction. The results of this small cohort study are limited in drawing conclusions as it lacked comparison to results achieved by individuals with classic middle ear reconstruction. According to the authors, most of the published data are based on only pure-tone audiograms. Concerning speech recognition after atresia repair, the author's state "long-term stability of the results has to be proven. Further refinements in the surgical technique, signal recording, and signal processing may yield normal hearing for these patients in the future."

Tysome and colleagues (2010) systematically reviewed 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 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. However, the authors recommend that additional study with long-term results is required to compare middle ear implants with conventional hearing aids.

In summary, the data in the trials submitted with the FDA-approval of the VSB implant and the scientific evidence in the peer-reviewed published literature suggests that semi-implantable middle ear hearing aids may provide marginal improvement in hearing compared to conventional externally worn acoustic hearing aids. The clinical significance of the improvement in functional gain, speech perception, and hearing ability in various listening situations is uncertain, although there appears to be a clear preference by users for the VSB implant (Sterkers, 2003). Given the safety and effectiveness of conventional externally worn acoustic hearing aids, and the increased risks inherent in a surgical procedure, a semi-implantable middle ear hearing aid must be associated with clinically significant improvement in various hearing parameters compared to externally worn hearing aids. While safety concerns appear to be minimal, only a limited number of individuals were included in the clinical trials, and long-term follow-up measures of durability, efficacy and safety have not been reported. Therefore, the scientific evidence does not support the use of a semi-implantable middle ear hearing aid for moderate to severe sensorineural hearing loss for all indications.

Fully Implantable Middle Ear Hearing Aids

In a prospective, single-subject, repeated-measures, phase I multicenter U.S. feasibility study, Chen and colleagues (2004) evaluated the safety and functionality of the Envoy^® System (St Croix Medical, Minneapolis, MN), a totally implantable middle ear hearing system for sensorineural hearing loss. Data was collected for multiple measures, including speech reception threshold, functional gain, word recognition, and adverse events. Testing was performed unaided with the subject's best-fit hearing aid and post-implant activation at two (trial endpoint) and four months. Five of seven subjects at the two-month postactivation period had working systems. All five subjects had perceived an increased benefit with the Envoy^® System over their best-fit hearing aid, including communication in high background noise levels. Word recognition was improved over hearing aids. Functional gain and speech reception thresholds were similar for the Envoy^® implant and hearing aids. A major concern was the number of implant failures, which were three at the two-month postactivation period. Implant modifications were completed prior to proceeding with the phase II clinical investigations.

Barbara and colleagues (2009) assessed the benefits of a totally implantable middle ear device, the Esteem 2^® (Envoy Medical Corporation, St Paul, MN) in subjects affected by moderate to severe sensorineural hearing loss as measured through pure tone audiometry testing carried out during the different postoperative fitting sessions. Six subjects were included in this study; selection was carried out via preoperative audiometric tests and thorough counseling, which considered information on previous experience with conventional hearing aids as well as each subject's motivation to undergo a surgical application. The implantation process induced deterioration in hearing thresholds, which fully recovered after activation of the device. A postoperative hearing gain could be measured in all three subjects; in this regard, the perceived quality of sound was shown to be better than could be expected by the measurable hearing gain. This study is limited by the small size, lack of a randomized control group, and self-reported outcome measures. In another case series, Barbara and colleagues (2011) reported of the use of the Esteem^® device in 21 individuals with severe bilateral sensorineural hearing loss. The authors reported mean hearing threshold levels improved overall from 70 to 48 dB. Limitations of this report are short-term results from a small number of subjects.

On March 17, 2010, the Esteem^® Implantable Hearing System received FDA approval through the PMA process as a totally implantable middle ear hearing aid "intended to alleviate hearing loss in patients by replicating the ossicular chain and providing additional gain" in adults 18 years of age or older with stable bilateral sensorineural hearing loss (FDA, 2010). The PMA pivotal clinical trial (unpublished to date) designed as a prospective, multi-center nonrandomized, single-arm study to evaluate safety and effectiveness of the Esteem^® device enrolled 62 subjects who acted as his or her own controls. A total of 61 subjects were followed out to one year. The implant had a five percent revision rate prior to the four month follow-up visit due to fibrotic tissue growth/interference and no revisions between the four and 10 month follow-up. Efficacy data was reported as statistically superior to the pre-implant hearing in two measures, however, the type of pre-implant hearing aid varied among subjects. Some side effects associated with the implantation of the Esteem^® included facial paralysis (7%) and taste disturbance (42%). The majority of the side effects reported resolved during the one-year study period.

The available evidence supports short-term safety and utility yet lacks data to support the long-term safety, efficacy, and durability of the Esteem^® implant when compared to other conventional hearing aids. In addition, the implantation requires a surgical procedure for insertion and battery replacement, which is dependent on the number of hours used and exposure to average noise level, estimated at 4.5 to nine years. According to the FDA's PMA application, two post-approval studies are required of the manufacturer to address the long-term (five years) safety and effectiveness of the Esteem^® implant. The first trial will study the Esteem^® Implantable Hearing System in the 57 participants in the PMA clinical trial reported to the FDA, reporting hearing outcomes of speech reception threshold and word recognition score along with adverse events. 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, single-arm observational study of 120 participants. This study will address safety at one month by evaluating the incidence of facial nerve injury (paralysis/paresis) and effectiveness at five years by evaluating speech reception threshold and word recognition score.

In summary, the evidence in the peer-reviewed published literature comparing the Esteem^® fully implantable middle ear hearing aid to other conventional hearing aids, such as bone conduction hearing aids is lacking. Additional studies measuring long-term safety and effectiveness outcomes are required to determine if the implant is superior to conventional hearing aids for those individuals with moderate to severe sensorineural hearing loss.

The basic types of hearing loss are conductive, sensorineural and mixed hearing loss. Sensorineural or "nerve" hearing loss involves damage to the inner ear or the eighth cranial nerve. It can be caused by aging, prenatal or birth-related problems, viral or bacterial infections, heredity, trauma, exposure to loud noises, the use of certain drugs, fluid buildup in the middle ear, or a benign tumor in the inner ear (acoustic neuroma). Since this type of hearing loss can affect selective portions of a person's range of hearing, the degree of hearing loss and the specific pitches affected will vary from person to person. Even in instances where the pattern of the loss is the same, the degree of sound clarity may vary from person to person or may differ between ears in an individual. As a result, individuals suffering from sensorineural hearing loss often require hearing aids tailored to the specific sensitivity and pattern of their hearing loss. Normal speech and conversation occurs at 40-60 dB within a frequency range of 500-3000 Hz. Degree of hearing loss (HL) refers to the severity of the loss. Specific numbers are representative of the person's thresholds, or the softest intensity at which sound is perceived. Clark (1981) reported on one of the more commonly used classification systems for designating the degree of hearing loss (ASLHA, 2010)

The most common type of hearing aid for moderate to severe sensorineural hearing loss is an externally worn acoustic hearing aid, which is placed into the external ear canal and functions to amplify sound. These hearing aids may not be satisfactory to some users, either 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 an externally worn acoustic hearing aid for an individual with moderate to severe sensorineural hearing loss. Two semi-implantable middle ear hearing aids have received FDA approval for use in adults, 18 years of age or older, who have moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. The Vibrant^® Soundbridge^® (VSB) (VIBRANT MED-EL Hearing Technology GMBH, Innsbruck, Austria) is the currently available semi-implantable electromagnetic middle ear hearing aid. The other FDA-approved semi-implantable middle ear hearing aid, the SOUNDTEC^® Direct System™ (SOUNDTEC, Inc., Oklahoma City, OK), is no longer available from the manufacturer (2004).

A semi-implantable middle ear hearing aid consists of three components: a magnetic component that is surgically implanted subcutaneously behind the ear and onto the ossicles of the middle ear (called the vibrating ossicular prosthesis [VORP]), a receiver, and an externally worn audio/sound processor. In the VSB implant, the processor is worn externally on the scalp over the receiver unit, held in place by a magnet. There is a fundamental difference as to how sound is amplified and delivered to the inner ear between the conventional acoustic hearing aid and an implantable middle ear hearing aid. An acoustic hearing aid receives sound from a microphone, amplifies and processes it and in turn reproduces increased acoustic sound pressure energy in the ear canal. In contrast, the semi-implantable middle ear hearing aid receives sound from a microphone, amplifies and processes it according to frequency shaping, and then delivers directly an electrical signal to an electromagnetic coil in the ear canal. This coil produces an electromagnetic field within the middle ear space which stimulates a magnet surgically attached under local anesthesia to the ossicular chain (stapes), causing vibrations of the bones of the middle ear similar to normal hearing.

The Esteem^® hearing implant is a fully implantable middle ear hearing system that uses piezoelectric transducers along with the natural ear/eardrum as the microphone. According to the FDA's Summary of Safety and Effectiveness Data, the hearing device consists of three implantable components: a sound processor implanted in the temporal bone behind the outer ear; a sensor; and a driver that is implanted in the middle ear. The piezoelectric sensor tip is attached to the incus bone and senses vibrations from the tympanic membrane and malleus/incus, converting these mechanical vibrations into electrical signals that are sent to the sound processor. The sound processor, which is implanted in the temporal bone and connected to the sensor and driver via leads, receives the electrical signal from the sensor, amplifies and filters the signal to compensate for the person's hearing loss profile; the enhanced signal is then sent to the driver. Finally, the piezoelectric driver tip attached to the stapes/incus bone converts the enhanced electrical signal received from the sound processor back to vibrations which are transferred to the stapes and delivered as sound waves to the cochlea; the cochlea converts the waves to nerve impulses and transmits them to the brain where they are interpreted as sound. In addition to the intended use by adults with stable moderate to severe bilateral sensorineural hearing loss (defined by PTA), the manufacturer states the Esteem^® is indicated for persons with an unaided speech discrimination test score equal to or greater than 40%, normally functioning eustachian tube, normal middle ear anatomy, normal tympanic membrane, and adequate space for the implant. The person should also have a minimum of 30 days of experience with appropriately fit hearing aids.

Air-conduction hearing aid (ACHA): A standard treatment for hearing loss that cannot be medically or surgically corrected. 

Aural atresia: Lack of development of the external ear canal.

Conductive hearing loss: Occurs when sound is not conducted efficiently through the outer ear canal to the eardrum and the small bones (ossicles) of the middle ear; involves a reduction in sound level or the ability to hear faint sounds.

Decibel (dB): A unit for expressing the loudness of sound.

Degree of hearing loss (HL): Refers to the severity of the hearing loss; range of numbers that represent the person's thresholds, or the softest intensity at which sound is perceived.

Hertz (Hz): Unit of frequency equivalent to 1 cycle per second; frequencies of 250-8000 Hz are typically used in audiometric testing because this range represents most of the speech spectrum.

Mixed hearing loss: Conductive hearing loss in combination with a sensorineural hearing loss; damage exists in the outer or middle ear and also in the inner ear (cochlea) or auditory nerve, in one or both ears.

Otitis externa: Inflammation or infection of the ear canal.

Piezoelectric: The production of an electric potential when stress is applied.

Pure tone audiometric air conduction testing: Performed by presenting a pure tone to the ear through an earphone; testing procedure repeated at specific frequencies from 250 to 8000 Hz for each ear with the thresholds  recorded on a graph (audiogram).

Pure tone average (PTA): The average of hearing sensitivity at 500, 1000, 2000, and 3000 Hz.

Pure tone thresholds (PTTs): The faintest tones or softest sound (lowest intensity) a person can hear at least 50% of the time; PTT is measured in dB.

Sensorineural hearing loss (SNHL): A type of permanent hearing loss related to the vestibulocochlear nerve (cranial nerve VIII), the inner ear, or central processing centers of the brain; hearing loss that involves a reduction in sound level or ability to hear faint sounds; affects speech understanding or the ability to hear clearly.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. 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.
2. 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):429-432.
3. 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):904-916.
4. Clark JG. Uses and abuses of hearing loss classification. ASHA. 1981; 23(7):493-500.
5. Coletti V, Soli SD, Carner M, Colletti L. Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol. 2006; 45(10):600-608.
6. Fisch U, Cremers CWR, Lenarz T, et al. Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol. 2001; 22(6):962-972.
7. Fraysse B, Lavielle JP, Schmerber S, et al. A multicenter study of the Vibrant Soundbridge middle ear implant: early clinical results and experience. Otol Neurotol. 2001; 22(6):952-961.
8. Frenzel H, Hanke F, Beltrame M, et al. Application of the Vibrant Soundbridge to unilateral osseous atresia cases. Laryngoscope. 2009; 119(1):67-74.
9. Kiefer J, Arnold W, Staudenmaier R. Round window stimulation with an implantable hearing aid (Soundbridge) combined with autogenous reconstruction of  the auricle - a new approach. ORL J Otorhinolaryngol Relat Spec. 2006; 68(6):378-385.
10. 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. 2002; 126(2):97-107.
11. Schmuziger N, Schimmann F, Wengen D, et al. Long-term assessment after implantation of the Vibrant Soundbridge device. Otol Neurotol. 2006; 27(2):183-188.
12. Snik AF, Cremers CW. Vibrant semi-implantable hearing device with digital sound processing: effective gain and speech perception. Arch Otolaryngol Head Neck Surg. 2001; 127(12):1433-1437.
13. Snik AF, Mylanus EA, Cremers CW, et al. Multicenter audiometric results with the Vibrant Soundbridge, a semi-implantable hearing device for sensorineural hearing impairment. Otolaryngol Clin North Am. 2001; 34(2):373-388.
14. 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. 2003; 24(3):27-36.
15. Streitberger C, Perotti M, Beltrame MA, Giarbini N. Vibrant Soundbridge for hearing restoration after chronic ear surgery. Rev Laryngol Otol Rhinol (Bord). 2009; 130(2):83-88.
16. 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):1369-1375.
17. Uziel A, Mondain M, Hagen P, et al. Rehabilitation for high-frequency sensorineural hearing impairment in adults with the Symphonix Vibrant Soundbridge: a comparative study. Otology and Neurotology. 2003; 24(5):775-783.
18. Verhaegen VJ, Mylanus EA, Cremers CW, Snik AF. Audiological application criteria for implantable hearing aid devices: a clinical experience at the Nijmegen ORL clinic. Laryngoscope. 2008; 118(9):1645-1649.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration (FDA) Device Approvals and Clearances. Esteem^® Implantable Hearing System. No. P090018. Rockville, MD: FDA. March 17, 2010. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P090018. Accessed on May 13, 2011.
2. U.S. Food and Drug Administration (FDA) Device Approvals and Clearances. Vibrant Soundbridge. No. P990052. Rockville, MD: FDA. August 31, 2000. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P990052. Accessed on May 13, 2011.

1. American Speech-Language-Hearing Association (ASLHA). Type, degree, and configuration of hearing loss. Available at:  http://www.asha.org/public/hearing/disorders/types.htm. Accessed on May 13, 2011.
2. National Institute on Deafness and Communication Disorders (NIDCD). Hearing aids. Available at: http://www.nidcd.nih.gov/health/hearing/hearingaid.asp. Accessed on May 13, 2011.

Esteem^®/Esteem 2^® System
Fully Implantable Middle Ear Hearing System
Implantable Middle Ear Hearing Aid
Semi-Implantable Middle Ear Hearing Aid
Vibrant^® Soundbridge^® System (VSB)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.