New Instrument for Parents Monitors Children for Middle Ear Fluid, A Key Sign of Ear Infections

Ear Infections are the Most Frequent Reason for Preschoolers' Doctor Visits

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WOBURN, Mass., Sept. 3, 1997 -- MDI Instruments, Inc. announced today that it has received FDA 510K clearance to market the EarCheck(TM) Middle Ear Monitor to consumers. The new instrument is the first in-home device that enables parents to monitor their children for middle ear fluid, frequently associated with otitis media (inflammation of the middle ear, with or without infection). Otitis media is the number one reason for doctor visits among preschool-aged children, accounting for more than 24.5 million such visits each year. Research shows that by the age of three, 83 percent of U.S. children have had one or more episodes of the disease, and 46 percent have had three or more episodes. Also, according to the Centers for Disease Control's most recent study on the disease, otitis media is on the rise. The number of office visits for children under two years of age tripled between 1975 and 1990, and doubled during that period for children aged two to five. Experts attribute the disease's rise to the increased numbers of children in group daycare settings.

"Until now, parents have had difficulty determining when a child needs to be seen by a physician for signs of ear infection. The EarCheck(TM) Middle Ear Monitor provides a quick and painless way for parents to detect middle ear fluid often associated with acute ear infections," said Sandra Kimball, MDI's Vice President of Medical and Regulatory Affairs. "Because it provides an objective way to interpret a child's symptoms, the EarCheck(TM) monitor will better enable parents to seek appropriate medical attention for their children, which may have a calming effect on worried parents. This can help prompt early treatment when necessary, especially for children who suffer from chronic ear infections. At the same time, it may benefit the health care system by reducing unnecessary office visits.

"Equally as important, the EarCheck(TM) monitor can help parents monitor their child for middle ear fluid which is often referred to as the 'hidden disease' because it can exist without signs of ear infection. Recent studies have shown that prolonged or chronic bouts of middle ear fluid can cause hearing impairment that may result in delayed language, speech and cognitive development, as well as motor skill development problems in children," said Kimball.

The EarCheck(TM) monitor determines the presence of fluid in the middle ear by using sonar, or sound wave, technology to measure the response of the eardrum to sound stimulus. The device is based on the EarCheck(TM) PRO(TM) instrument, a product developed by MDI which is designed for use by physicians. The handheld instrument is quick and easy to use, and painless for the child.

The EarCheck(TM) monitor will be available to consumers in the fall of 1997. It will initially be available through The Sharper Image and The Right Start catalogs and retail stores. Consumers can also call 800-EARCHEK for further purchase information.

Founded in 1994, MDI Instruments, Inc. is a privately-held company that develops and markets non-invasive medical instruments that improve the quality of health care for children. The company's medical advisory board consists of leading physicians in pediatrics and otolaryngology. MDI Instruments is based in Woburn, Massachusetts.

EarCheck(TM) and the EarCheck(TM) logo are trademarks of MDI Instruments, Inc.

CONTACT: Tracy Morris or Scott Woldman, both of Healy Communications, 312-440-3900, for MDI Instruments