Esteem Hearing Implant Andrew Dunne
What is Esteem? • A totally implantable hearing system that is implanted under the skin behind the ear and within the middle ear space • For moderate and severe sensorineural hearing loss • Sensorineural hearing loss -- Loss of hearing resulting from problems in the inner ear, the cochlear nerve, or in the brain. • Has no microphone • Uses the functioning eardrum to pick up vibrations • Adjusts vibrations to individual hearing needs • Pacemaker like battery • Needs replacement after 4.5 to 9 years of continuous use. • battery replaced in a minor outpatient surgical operation.
Parts • Two piezoelectric transducers implanted in the middle ear • Sensor – surgically attached to incus • Driver – attached to stapes • Sound Processor • Implanted behind the ear in a boney well • Hold battery • Personal Programmer • Turns Esteem on/off • Select volume levels • Three program settings
How it works I • Sound travels down ear canal and vibrates eardrum • Sensor • Picks up vibrations from incus. • Converts vibrations into electrical signals which are sent to the sound processor. • Processor • The digital signals are modified depending on patients individual needs • Determined by variety of hearing tests
How it works II • Driver • Converts the new electrical signals into mechanical vibrations. • Transmits these signals to the stapes and the cochlea Sound Processor Driver Incus and Stapes surgically separated to prevent feedback. Sensor
Study • Study began in 2007 • Esteem implanted in 6 patients • 5 right ear, 1 left ear • Hearing tests before, after surgery, after activation • Duration of surgical procedure varied • First – 8h 10min • Last – 3h 50min • Average – 5h 45min • Implant activated 2 months afterwards
Results • 3 of the 6 patients had implant activated. • Reasons were not discussed • Audiometric results • Mean (250-4000Hz) actual hearing gain as compared to preoperative hearing threshold • Patient 1 – 26dB • Patient 2 – 9dB • Patient 3 – 11dB • Mean actual hearing gain comparedto postoperative hearing threshold • Patient 1 – 65dB • Patient 2 – 41dB • Patient 3 – 61dB
Issues / benefits • Long surgical procedure with steep learning curve • Highly Invasive surgical procedure • Interruption of the ossicular chain • Causes additional hearing loss initially • Completely invisible to self and others • No acoustic feedback • Maintenance free
Approval • Earned the CE mark of approval • FDA approved on March 17, 2010 • Direct cost to the recipient for device and implant surgery is approximately $30,000. Financing options are available.
References • Barbara, M, Manni, V, & Monini, S. (2009). totally implantable middle ear device for rehabilitation of sensorineural hearing loss: preliminary experience with the esteem®, envoy. Acta Oto- laryngologica, 129(4), 429-432. • http://www.envoymedical.com/get-informed • http://www.medgadget.com/archives/2010/03/envoy_esteem_first_totally_implantable_hearing_system_gains_fda_approval.html