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Semin Hear 2010; 31(1): 028-036
DOI: 10.1055/s-0029-1246322
© Thieme Medical Publishers

Implantable Middle Ear Hearing Devices: A Review

Marc K. Bassim1 , José N. Fayad1
  • 1House Ear Clinic, University of Southern California Medical School, Los Angeles, California
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Publication History

Publication Date:
10 March 2010 (online)

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ABSTRACT

Implantable middle ear hearing devices (IMEHDs) were developed in an effort to improve on the limitations of traditional hearing aids. The last few years have seen significant advances in this technology with the emergence of several new devices, including fully implantable prostheses. As more patients are being implanted, experience with these devices has increased and refinements have been made. The indications also have expanded to include patients with mixed hearing loss in addition to those with pure sensorineural hearing loss, with application of the transducer to either the ossicles or the oval or round window. Fully implantable devices also are gaining ground, although most of these are relatively new and are still in the early stages of clinical application. Each device has its specifics in terms of design, indications, and implantation. Clinical outcomes also have varied, with some devices not surviving early clinical trials.

This article reviews the mechanical concepts and design of IMEHDs, as well as the design, indications, and latest outcomes of the IMEHDs currently available on the market.

KEYWORDS

Implantable middle ear hearing device - Vibrant Soundbridge - Otologics middle ear transducer (MET) - Envoy Esteem - SoundTec - TICA - fully implantable hearing aid

REFERENCES

  • 1 Goode R L, Rosenbaum M L, Maniglia A J. The history and development of the implantable hearing aid.  Otolaryngol Clin North Am. 1995;  28(1) 1-16
    PubMedSearch in Google Scholar
  • 2 Spindel J H. Middle ear implantable hearing devices.  Am J Audiol. 2002;  11(2) 104-113
    CrossrefPubMedSearch in Google Scholar
  • 3 Truy E, Philibert B, Vesson J F, Labassi S, Collet L. Vibrant Soundbridge versus conventional hearing aid in sensorineural high-frequency hearing loss: a prospective study.  Otol Neurotol. 2008;  29(5) 684-687
    CrossrefPubMedSearch in Google Scholar
  • 4 Backous D D, Duke W. Implantable middle ear hearing devices: current state of technology and market challenges.  Curr Opin Otolaryngol Head Neck Surg. 2006;  14(5) 314-318
    CrossrefPubMedSearch in Google Scholar
  • 5 Dyer Jr R K, Nakmali D, Dormer K J. Magnetic resonance imaging compatibility and safety of the SOUNDTEC Direct System.  Laryngoscope. 2006;  116(8) 1321-1333
    CrossrefPubMedSearch in Google Scholar
  • 6 Todt I, Seidl R O, Mutze S, Ernst A. MRI scanning and incus fixation in Vibrant Soundbridge implantation.  Otol Neurotol. 2004;  25(6) 969-972
    CrossrefPubMedSearch in Google Scholar
  • 7 Truy E, Eshraghi A A, Balkany T J, Telishi F F, Van De Water T R, Lavieille J P. Vibrant Soundbridge surgery: evaluation of transcanal surgical approaches.  Otol Neurotol. 2006;  27(6) 887-895
    CrossrefPubMedSearch in Google Scholar
  • 8 Colletti V, Soli S D, 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
    CrossrefPubMedSearch in Google Scholar
  • 9 Beltrame A M, Martini A, Prosser S, Giarbini N, Streitberger C. Coupling the Vibrant Soundbridge to cochlea round window: auditory results in patients with mixed hearing loss.  Otol Neurotol. 2009;  30(2) 194-201
    CrossrefPubMedSearch in Google Scholar
  • 10 Fayad J N, Bassim M K, Barreiro K. Implantation of a round window stimulator in a radical mastoidectomy cavity.  Otolaryngol Head Neck Surg. 2009;  140(2) 267-269
    CrossrefPubMedSearch in Google Scholar
  • 11 Venail F, Lavieille J P, Meller R, Deveze A, Tardivet L, Magnan J. New perspectives for middle ear implants: first results in otosclerosis with mixed hearing loss.  Laryngoscope. 2007;  117(3) 552-555
    CrossrefPubMedSearch in Google Scholar
  • 12 Cremers C W, Verhaegen V J, Snik A F. The floating mass transducer of the Vibrant Soundbridge interposed between the stapes and tympanic membrane after incus necrosis.  Otol Neurotol. 2009;  30(1) 76-78
    CrossrefPubMedSearch in Google Scholar
  • 13 Huber A M, Ball G R, Veraguth D, Dillier N, Bodmer D, Sequeira D. A new implantable middle ear hearing device for mixed hearing loss: a feasibility study in human temporal bones.  Otol Neurotol. 2006;  27(8) 1104-1109
    CrossrefPubMedSearch in Google Scholar
  • 14 Uziel A, Mondain M, Hagen P, Dejean F, Doucet G. Rehabilitation for high-frequency sensorineural hearing impairment in adults with the Symphonix Vibrant Soundbridge: a comparative study.  Otol Neurotol. 2003;  24(5) 775-783
    CrossrefPubMedSearch in Google Scholar
  • 15 Needham A J, Jiang D, Bibas A, Jeronimidis G, O'Connor A F. The effects of mass loading the ossicles with a floating mass transducer on middle ear transfer function.  Otol Neurotol. 2005;  26(2) 218-224
    CrossrefPubMedSearch in Google Scholar
  • 16 Vincent C, Fraysse B, Lavieille J P, Truy E, Sterkers O, Vaneecloo F M. A longitudinal study on postoperative hearing thresholds with the Vibrant Soundbridge device.  Eur Arch Otorhinolaryngol. 2004;  261(9) 493-496
    CrossrefPubMedSearch in Google Scholar
  • 17 Mosnier I, Sterkers O, Bouccara D et al.. Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years.  Ear Hear. 2008;  29(2) 281-284
    CrossrefPubMedSearch in Google Scholar
  • 18 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) 427-436
    CrossrefPubMedSearch in Google Scholar
  • 19 Todt I, Seidl R O, Ernst A. Hearing benefit of patients after Vibrant Soundbridge implantation.  ORL J Otorhinolaryngol Relat Spec. 2005;  67(4) 203-206
    PubMedSearch in Google Scholar
  • 20 Luetje C M, Brackman D, Balkany T J 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
    CrossrefPubMedSearch in Google Scholar
  • 21 Snik A F, Mylanus E A, Cremers C W 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
    CrossrefPubMedSearch in Google Scholar
  • 22 Fraysse B, Lavieille J P, 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
    CrossrefPubMedSearch in Google Scholar
  • 23 Schmuziger N, Schimmann F, àWengen D, Patscheke J, Probst R. Long-term assessment after implantation of the Vibrant Soundbridge device.  Otol Neurotol. 2006;  27(2) 183-188
    CrossrefPubMedSearch in Google Scholar
  • 24 Todt I, Seidl R O, Gross M, Ernst A. Comparison of different Vibrant Soundbridge audioprocessors with conventional hearing aids.  Otol Neurotol. 2002;  23(5) 669-673
    CrossrefPubMedSearch in Google Scholar
  • 25 Jenkins H A, Atkins J S, Horlbeck D et al.. U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator.  Otolaryngol Head Neck Surg. 2007;  137(2) 206-212
    CrossrefPubMedSearch in Google Scholar
  • 26 Kasic J F, Fredrickson J M. The Otologics MET ossicular stimulator.  Otolaryngol Clin North Am. 2001;  34(2) 501-513
    CrossrefPubMedSearch in Google Scholar
  • 27 Lefebvre P P, Martin C, Dubreuil C et al.. A pilot study of the safety and performance of the Otologics fully implantable hearing device: transducing sounds via the round window membrane to the inner ear.  Audiol Neurootol. 2009;  14(3) 172-180
    PubMedSearch in Google Scholar
  • 28 Tringali S, Pergola N, Berger P, Dubreuil C. Fully implantable hearing device with transducer on the round window as a treatment of mixed hearing loss.  Auris Nasus Larynx. 2009;  36(3) 353-358
    CrossrefPubMedSearch in Google Scholar
  • 29 Jenkins H A, Atkins J S, Horlbeck D et al.. Otologics fully implantable hearing system: Phase I trial 1-year results.  Otol Neurotol. 2008;  29(4) 534-541
    CrossrefPubMedSearch in Google Scholar
  • 30 Jenkins H A, Niparko J K, Slattery W H, Neely J G, Fredrickson J M. Otologics Middle Ear Transducer Ossicular Stimulator: performance results with varying degrees of sensorineural hearing loss.  Acta Otolaryngol. 2004;  124(4) 391-394
    CrossrefPubMedSearch in Google Scholar
  • 31 Chen D A, Backous D D, Arriaga M A 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
    CrossrefPubMedSearch in Google Scholar
  • 32 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
    CrossrefPubMedSearch in Google Scholar
  • 33 Hough J V, Matthews P, Wood M W, Dyer Jr R K. Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial.  Otol Neurotol. 2002;  23(6) 895-903
    CrossrefPubMedSearch in Google Scholar

Jose N FayadM.D. 

House Clinic, USC Medical School, 2100 West 3rd Street

Los Angeles, CA 90057

Email: jfayad@hei.org