Abstract
Hearing aids have evolved significantly since the use of ear trumpets in the seventeenth century and vacuum tube amplifiers in the early twentieth century. Advances in technology have led to the development of devices that are considerably smaller and more powerful than those that were first marketed to the hearing impaired. However, despite these improvements, a substantial portion of patients with hearing loss are not regular hearing aid users, citing concerns over cost of purchase and device maintenance, cosmetic appearance, discomfort and ear canal irritation, signal distortion, feedback, and insufficient gain [1]. The impetus for the development of active middle ear implants was to overcome many of the drawbacks of conventional air conduction hearing aids [2–4]. Theoretically, a totally implantable system would afford complete concealment and improved freedom, permitting water exposure and use during sleep. Furthermore, by utilizing an implantable microphone and vibromechanical transducer, the ear canal can be effectively bypassed and feedback minimized. The Envoy Esteem® remains the first and only completely implantable hearing aid to have approval by the United States Food and Drug Administration (FDA) for patient use. The Esteem utilizes a unique implanted piezoelectric sensor and driver system that receives, processes, and amplifies sound. This chapter will address the history of the Esteem® Hearing Implant and provide a summary of its surgical implantation and clinical outcomes.
Disclosures
Michael E. Glasscock III, MD, is a consultant and stockholder in Envoy Medical. There are no other relevant financial disclosures.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Gates G, Cooper Jr JC, Kannel WB, Miller NJ. Hearing in the elderly: the Framingham cohort, 1983-1985. Part I Basic audiometric test resuls. Ear Hear. 1990;11(4):247–56.
Pacala JT, Yueh B. Hearing deficits in the older patient: “I didn’t notice anything.”. JAMA. 2012;307(11):1185–94.
Laplante-Lévesque A, Hickson L, Worrall L. Factors influencing rehabilitation decision of adults with acquired hearing impairment. Int J Audiol. 2010;49(7):497–507.
Stach BA, Ramachandran V. Hearing Aids. In: Gulia AJ, Minor LB, Poe DS, editors. Surgery of the ear. 6th ed. Shelton: PMPH-USA; 2010. p. 281–92.
Miller DA, Sammeth CA. Middle ear implantable hearing devices. In: Valente M, Hosford-Dunn H, Roeser RJ, editors. Audiology. Treatment. 2nd ed. New York: Thieme Medical Publishers, Inc.; 2008. p. 324–43.
Slattery III WH. Implantable hearing devices. In: Brackmann DE, Shelton C, Arriaga MA, editors. Otologic surgery. 3rd ed. Philadelphia: Elsevier Inc; 2010. p. 383–96.
Chen DA, Backous DD, Arriaga MA, Garvin R, Kobylek D, Littman T, Walgren S, Lura D. Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss. Otolaryngol Head Neck Surg. 2004;131(6):904–16.
Kraus EM, Shohet JA, Catalano PJ. Envoy Esteem totally implantable hearing system: phase 2 trial, 1-year hearing results. Otolaryngol Head Neck Surg. 2011;145(1):100–9.
Brownell WE. The piezoelectric outer hair cell. In: Eatock RA, Fay RR, Popper AN, editors. Vertebrate hair cells. New York: Springer; 2006.
Howells CA. Piezoelectric energy harvesting. Energy Conserv Manag. 2009;50(7):1847–50.
Kirkwood DH. Middle ear implants offer potential: new breed of devices may stimulate compliance, experts say. ENT Today. 2011. Available at: http://www.enttoday.org/details/article/1057637/Middle_Ear_Implants_Offer_Potential_New_breed_of_devices_may_stimulate_complianc.html. Accessed 1 May 2014.
FDA – Esteem® Implantable Hearing System – P090018. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm212633.htm. Accessed 1 May 2014.
Barbara M, Manni V, Monini S. Totally implantable middle ear device for rehabilitation of the sensorineural hearing loss: preliminary experience with the Esteem®. Envoy Acta Otolaryngol. 2009;129:429–32.
Memari F, Asghari A, Danesi A, Jalali A. Safety and patient selection of totally implantable hearing aid surgery: envoy system. Esteem Eur Arch Otorhinolaryngol. 2011;268:1421–5.
The Esteem Implant. Available at: http://envoymedical.com/the-esteem-implant/. Accessed 1 May 2014.
The Esteem Implant: Indications. Available at: http://envoymedical.com/the-esteem-implant/indications/. Accessed 1 May 2014.
Murali S, Krishnan PV, Bansal T, Karthikeyan K, Natarajan K, Kameswaran M. Totally implantable hearing aid surgical technique and the first Indian experience with envoy esteem. Indian J Otolaryngol Head Neck Surg. 2009;61(3):245–51.
Monini S, Biagini M, Atturo F, Barbara M. Esteem® middle ear device versus conventional hearing aids for rehabilitation of bilateral sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2013;270(7):2027–33.
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. 2012;33:916–21.
Shohet JA, Kraus EM, Catalano PJ. Profound high-frequency sensorineural hearing loss treatment with a totally implantable hearing system. Otol Neurotol. 2011;32:1428–31.
Barbara M, Biagini M, Monini S. The totally implantable middle ear device ‘Esteem’ for rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol. 2011;131:399–404.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer India
About this chapter
Cite this chapter
Sweeney, A.D., Carlson, M.L., Glasscock, M.E. (2014). The Envoy Esteem® Hearing Implant. In: Mankekar, G. (eds) Implantable Hearing Devices other than Cochlear Implants. Springer, New Delhi. https://doi.org/10.1007/978-81-322-1910-1_5
Download citation
DOI: https://doi.org/10.1007/978-81-322-1910-1_5
Published:
Publisher Name: Springer, New Delhi
Print ISBN: 978-81-322-1909-5
Online ISBN: 978-81-322-1910-1
eBook Packages: MedicineMedicine (R0)