1. Esteem Hearing Implant Andrew Dunne

2. 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.

3. 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

4. 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

5. 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.

6. 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

7. 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

8. 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

9. 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.

10. 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.envoymedical.com/get-informed  http://www.medgadget.com/archives/2010/03/envoy_estee m_first_totally_implantable_hearing_system_gains_fda_a pproval.html http://www.medgadget.com/archives/2010/03/envoy_estee m_first_totally_implantable_hearing_system_gains_fda_a pproval.html