MED-EL's OPUS 2 Speech Processor Receives FDA Approval

Editor: MED-EL is becoming a formidable competitor to the "Big 2" in the US cochlear implant market. Here's information on the recent FDA approval of their OPUS 2 speech processor.

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

May 2008

First Switch-Free Speech Processor Available in the World

Durham, NC -- MED-EL Corporation announced today the U.S. Food and Drug Administration (FDA) approval of the new OPUS 2 cochlear implant speech processor. The OPUS 2 is the first speech processor that is designed for switch-free operation, with special features for bilaterally implanted listeners. It is operated entirely by a remote control unit, the FineTuner(tm), which enables changes to settings without removing the processor from the ear. The FineTuner is designed to communicate with two speech processors, reaching new heights in ease of use for people who use cochlear implants in both ears. An integrated telecoil and a universal direct input for wireless FM and Bluetooth(r) connection (using third-party FM and Bluetooth equipment) ensure easy and comfortable interaction with the surrounding world. An optional private alert indicates program changes and battery status to the user.

Most Sophisticated Technologies

The OPUS 2 also features the latest high-performance microchip technology, developed to offer greater sound detail and clarity with MED-EL's proprietary Fine Structure Processing(tm) (FSP) sound coding strategy. "Fine structure" refers to the detailed pitch and timing cues that are particularly important when listening to music or having conversations in noisy environments. Fine structure cues have not been deliberately included in cochlear implant coding strategies up to now. A High Definition Continuous Interleaved Sampling (HD-CIS) coding strategy is also offered.

"The OPUS 2 represents a significant technological development," said Kim Jackson, Vice President of Clinical and Sales for North America. "It is the smallest speech processor available for any cochlear implant system, and offers listeners state of the art sound processing technology. We are proud to lead the industry in research and new product innovation to better serve people with severe to profound hearing loss."

Size, Weight and Comfort Matters

With a weight of only 10.1g (incl. the new DaCapo ear-level rechargeable battery) and a thickness of 7.0 - 8.7 mm the OPUS 2 is clearly the thinnest and lightest speech processor on the market. With a modular system of interchangeable wearing options, the OPUS 2 can be customized to meet individual needs, including special solutions for toddlers and practical options for active teens and the elderly. The processor is available in six colors.

Energy-efficient technology ensures an exceptionally long battery life, typically three to five days of use on a single set of disposable batteries. An LED indicator signals error conditions and provides troubleshooting support, which is especially useful for parents and teachers working with young children with implants.

The FSP strategy is approved for use by cochlear implant users with at least six months experience with the Continuous Interleaved Sampling (CIS+) or HD-CIS programming options, and who have the cognitive ability to express a choice in coding strategy preference. The safety and effectiveness of FSP have not yet been established in pre-lingually deaf children and it is not indicated for use in that population.

The latest member of the MED-EL MAESTRO(tm) cochlear implant system

The OPUS 2 speech processor completes the MAESTRO(tm) cochlear implant system. MAESTRO(tm) is comprised of four compatible components of cochlear implants (SONATATI100, PULSARCI100) and speech processors (OPUS 1, OPUS 2) providing surgeons and candidates the option of selecting the best possible solution for each individual case. The combined technical features provide opportunities for both the highest wearing comfort and the best possible hearing experience.

About MED-EL Corporation