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

Sensor

Driver

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 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