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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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Esteem hearing implant l.jpg

Esteem Hearing Implant

Andrew Dunne


What is esteem l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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


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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.


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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


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