SAN CARLOS, Calif.--(BUSINESS WIRE)--May 30, 2003--Natus Medical Incorporated (Nasdaq:BABY) ("Natus") today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new ALGO(R) 3i Newborn Hearing Screener. The ALGO 3i screening system will be introduced at the Association of Women's Health, Obstetrics and Neonatal Nurses (AWHONN) annual meeting being held June 1-4, in Milwaukee, Wisconsin.

The new ALGO 3i system is expected to accommodate a wide range of clinical environments through its unique hand-held size and versatile screening features. Unlike most hand-held hearing screeners currently on the market, the ALGO 3i system screens both ears simultaneously, providing a more efficient screening process. The device also allows users to select from several language options to readily conduct a test. In addition, the ALGO 3i system fulfills some of the basic data management needs of healthcare institutions by allowing users to enter unique patient information, conduct wireless printing of screening results, and perform wireless transfer of screening data to a personal computer. Finally, the ALGO 3i system provides automated "pass" and "refer" results and standardized screening parameters, allowing individuals with varying levels of expertise to more easily conduct a test.

Like all other ALGO systems, the ALGO 3i screener incorporates proprietary Natus AABR(R) technology, which screens the baby's entire hearing pathway -- from the ear to the brainstem. Several published, peer-reviewed studies have demonstrated that ALGO AABR technology has achieved the highest clinical accuracy compared to other hearing screening technologies. Moreover, ALGO screeners have been shown to meet the American Academy of Pediatrics guidelines for newborn hearing screening.

"The ALGO 3i system reflects the on-going dialogue that Natus has conducted over the years with clinicians and screening personnel worldwide. We believe this new ALGO system's unique size and versatile design will easily adapt to a variety of screening personnel and clinical settings, thereby addressing the newborn hearing screening needs of healthcare providers at a global level," said Tim Johnson, president and chief executive officer of Natus.

"Natus has over 14 years of experience helping clinicians establish successful newborn hearing screening programs. Consequently, its ALGO systems have screened over 10 million babies for hearing loss worldwide and are currently installed in 24 countries. Designed as a replacement to our existing ALGO(R) Portable Newborn Hearing Screener, we believe the new ALGO 3i system will be well received both domestically and internationally," added Johnson.

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