Download 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

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
Sensor
Incus and Stapes
surgically separated
to prevent feedback.
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 compared
to 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 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