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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

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Presentation Transcript
what is esteem
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
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
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
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
  • 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
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
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
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
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