FDA Approves the MED-EL SONATA Cochlear Implant

Editor: MED-EL is the "other" manufacturer of cochlear implants. They're not well known in the US, because they just recently started selling implants here. But they've had a large portion of the European market for years.

Their newest CI has just been approved by the FDA. Here's the press release.

~~~~~~~~~~~~~~~~~

MED-EL Now Accepting Orders for Smallest, Thinnest, Lightest Weight Titanium Cochlear Implant

Durham, NC-(June 27, 2007)-MED-EL Corporation announced today the U.S. Food and Drug Administration approval of the SONATATI100 cochlear implant.

"The SONATATI100 offers cochlear implant candidates and their surgeons a new choice in housing as they evaluate implant options," said Kim Jackson, Vice President of Clinical Services. "The smaller incision required for this implant translates to a smaller surgical site - a key consideration for cochlear implant candidates, particularly children, and an alternate surgical approach for surgeons." More than 1,150 hearing healthcare professionals heard about the SONATATI100, which was approved last year for the EU and other non-US markets, at the biennial International Conference on Cochlear Implants in Charlotte, NC, in April.

Engineered for unparalleled precision and performance, both MED-EL's SONATATI100 and PULSARCI100 cochlear implants combine the smallest, thinnest and lightest weight implant available with MED-EL's powerful next generation I100 electronics. This technology is essential for MED-EL's advanced research and developments in the areas of music enjoyment and speech understanding in difficult listening situations. The SONATATI100 and PULSARCI100 are also "future-ready," designed to implement future upgrades and enhancements.

Available features include:
* Sophisticated I100 electronics for unprecedented sound clarity and detail
* Sequential stimulation and biphasic pulses
* Impedance and Field Telemetry
* A choice of electrode options to address specific medical situations for maximum benefit

Features under developmenti:
* Fast stimulation rates of up to 50,700 pulses per second
* Parallel stimulation and triphasic pulses
* Safety features, including a unique implant ID
* Status Telemetry and Auditory Nerve Response Telemetry

The electronic components of MED-EL's cochlear implants are arranged on a single custom-designed ASIC (Application Specific Integrated Circuit) microchip. The microchip allows more information to be processed, while maintaining low energy requirements. MED-EL's power-efficient technology makes it possible to provide recipients the benefits of high-rate stimulation with the comfort of a behind-the-ear (BTE) speech processor. This energy efficiency translates into long battery life, typically three to five days of use per set of batteries.

Additionally, the SONATATI100 and PULSARCI100 have 24 independent current sources for highly precise, high-rate stimulation over the entire length of the cochlea. Research has shown that an optimal rate causes the auditory nerve to behave as in the normal hearing process. MED-EL's cochlear implants mimic this process (stochastic behavior) by stimulating at rates matching the abilities of the recipient's auditory nerve.

About Hearing Loss in the United States

Hearing loss has a profound impact on the everyday lives of Americans. Approximately 31.5 million Americans - or 1 in 10 - suffer from some kind of hearing loss.ii The most common form of hearing loss is sensorineural, which affects an estimated 60 percent of those with hearing loss. This involves damage to the inner ear caused by aging, pre-natal and birth-related problems, viral and bacterial infections, heredity, trauma, exposure to loud noise, or a benign tumor in the inner ear, as well as a significant number of unknown reasons.

About MED-EL Corporation

Since its founders developed one of the world's first cochlear implants in 1975, MED-EL has set new standards in hearing implant technologies, developing and manufacturing technologically advanced hearing solutions for people with varying degrees of hearing loss. MED-EL hearing implant systems, currently used in 70 countries, combines the latest scientific advances, engineering and manufacturing techniques for performance, safety and reliability.

In addition to SONATATI100, products available in the United States include the PULSARCI100 cochlear implant, designed for unprecedented precision in the transfer of sound information to the auditory nerve. The TEMPO+ speech processor is the smallest and lightest system on the market, with the thinnest profile of any BTE speech processor. MED-EL also recently launched the VIBRANT SOUNDBRIDGE(r), the first FDA-approved implantable middle ear prosthesis indicated for use in adults who have moderate-to-severe sensorineural hearing loss and who cannot medically tolerate an acoustic hearing aid. For more information, visit www.medel.com or call 888-MED-EL-CI (633-3524).