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EarCheck Pro Receives FDA 510K Clearance

New Instrument Used in Diagnosis of Ear Infections Enhances Clinical Accuracy and Eliminates Painful Ear Exams; Ear Infections are the Most Frequent Reason for Children's Doctor Visits



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WOBURN, Mass., May 28, 1997 -- MDI Instruments, Inc. announced today that the FDA has given the company 51OK clearance to market the EarCheck Pro(TM) Otitis Media Detector. The new instrument is designed to facilitate physicians' diagnosis of otitis media (inflammation with or without infection of the middle ear), the most frequent reason for visits to the doctor by children, by confirming the presence of middle ear effusion (fluid). Incidences of otitis media are on the rise, increasing 150 percent between 1975 and 1990. Recent studies show that the disease accounts for more than 24.5 million doctor visits by preschoolers each year. The annual cost of medical and surgical treatment of otitis media in the U.S. is estimated at between $3 billion and $4 billion.

"Currently available confirmatory tests, including tympanometry, may be painful and need the cooperation of a sick child. Children with acute otitis media are frequently too uncomfortable to tolerate pressurization of the ear canal required by tympanometry, and are unable to be tested. This is exactly the population that should be tested," said Sandra Kimball, MDI's Vice President of Medical and Regulatory Affairs. "As a result, today's physicians have a tremendous need for a patient- and physician-friendly instrument that enhances their ability to make a quick and accurate diagnosis."

Clinical studies have determined that the EarCheck Pro is comparable in accuracy to a tympanometer for detecting middle ear effusion. Unlike a tympanometer, however, the EarCheck Pro is painless because it relies on sonar-like technology (acoustic reflectometry), which does not require an airtight seal or pressurization of a child's ear canal.

"Given the increasing prevalence of otitis media, the issue of misdiagnosis is a significant, yet often undiscussed concern," said Jerome 0. Klein, M.D., Professor of Pediatrics at Boston University School of Medicine and coauthor of the book, "Otitis Media in Infants and Children." "While existing instruments can help diagnose these diseases, some preschool-aged children cannot be tested using a tympanometer." According to an article in "Contemporary Pediatrics" (November 1993), among infants aged three months to 24 months, the age group in which otitis media is most prevalent, up to 28 percent cannot tolerate tympanometry.

Because middle ear effusion (MEE) is an indicator of past, present or future ear infections, experts recommend that all children be tested for the condition, not only when evidencing signs of infection, but also during every well-child exam. This is important because MEE can exist without signs of ear infection. As a result, MEE is often called "the hidden disease." Recent studies have shown prolonged or chronic bouts of middle ear fluid to cause hearing impairment that may result in language and speech disorders and motor skill development problems in preschoolers.

"It is extremely important that all infants and children be screened for the conductive hearing loss associated with middle ear effusion. MEE in the first two or three years of life can have a significant adverse effect on the cognitive and communicative abilities of children," said Jerome T. Combs, M.D., Department of Pediatrics, Hospital of Saint Raphael in New Haven, Connecticut. "The primary care physician who never screens for MEE during well-baby examinations will miss about 25 percent of infants with this potential cause of conductive hearing loss."

The handheld EarCheck Pro is quicker and easier to use than a tympanometer. It can slip into a physician's pocket, and does not require a child to be moved from room to room. At $399 suggested physician price, it is also more affordable than a tympanometer, which typically costs between $2,000 and $3,500. In addition to helping to confirm diagnosis, the portable and quick EarCheck Pro can be used as a screening device and to monitor ongoing treatment following ear infections.

Because of increasing pressure within managed care organizations to minimize office visits, many primary care physicians rely solely on the otoscope to diagnose acute otitis media (AOM) and associated middle ear fluid. However, otoscopy is largely subjective because it is a visual exam. When used as a confirmatory tool, the EarCheck Pro can help to enhance diagnostic accuracy and limit unnecessary prescription of antibiotics that can result from overdiagnosis of AOM.

The EarCheck Pro determines the condition of the middle ear by measuring the response of the eardrum to sound stimulus. Using a built-in microphone and a microprocessor, EarCheck Pro registers the intensity of different frequencies of a reflected sound and analyzes the results to determine the absence or presence of fluid in the middle ear. Like a tympanometer, the EarCheck Pro is reimbursable by insurers under CPT Code 92567 for impedance testing. The instrument is available for purchase by physicians immediately, who can call toll-free 888-327-2435 for more information on distributors selling the product in their area.

Founded in 1994, MDI Instruments is a privately-held company that develops, produces and markets non-invasive medical instruments that improve the quality of health care for children. The company's medical advisory board consists of some of the country's most pre-eminent physicians in pediatrics and otolaryngology. MDI Instruments is based in Woburn, Massachusetts. EarCheck Pro(TM) is a trademark of MDI Instruments, Inc.

CONTACT: Tracy Morris or Scott Woldman of Healy Communications, 312-440-3900

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