Transcript Esteem Hearing Implant

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