EarPopper(TM) Immediately Restores Hearing, Resolves Middle Ear Fluid Without Antibiotics or Tubes

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 19, 2005--

New Device Treats One of the Top Reasons for Doctor Visits Among Children

“As a non-surgical, non-drug device, the EarPopper reduces the risks associated with the overuse of antibiotics and surgical insertion of ear tubes.”

Middle ear fluid is one of the most common reasons U.S. children visit the doctor, second only to the common cold, resulting in more than 30 million doctor visits each year and adding $4 billion in medical costs to the health care system. Although increasing concerns about the risks of resistance to antibiotics recently led doctors to recommend "watchful waiting" as the first line of treatment(a), more than 10 million antibiotic prescriptions are written annually to treat middle ear fluid or Otitis Media with Effusion (OME). Persistent OME is often treated with surgical insertion of ear ventilation tubes. More than 700,000 children undergo this procedure each year. In many cases both antibiotics and surgery have proven problematic and often unsuccessful.

Now patients have a simple, non-invasive device that offers a safe and clinically-proven treatment for middle ear fluid. The hand-held, battery-operated EarPopper(TM) delivers a constant, controlled stream of air pressure and flow into the nasal cavity, diverting air up the Eustachian tube when the patient swallows. This action clears and ventilates the middle ear and restores hearing immediately.

"The EarPopper will bring relief to millions of children who are suffering hearing loss and may be experiencing educational, emotional, academic and behavioral challenges due to middle ear fluid," said Dr. Shlomo Silman, co-inventor of the EarPopper and a professor of Hearing Sciences and Audiology at Brooklyn College. "The device, which can be used at home with a prescription, will help families avoid recurring visits to the doctor for treatment."

"Current therapeutic choices to treat middle ear fluid range from prescribing antibiotics, whose results are controversial, to the surgical insertion of ear tubes," said Dr. Daniel S. Arick, a Board-Certified otolaryngologist in private practice in New York City and co-inventor of the EarPopper. "As a non-surgical, non-drug device, the EarPopper reduces the risks associated with the overuse of antibiotics and surgical insertion of ear tubes."

In a four-year study sponsored by the National Institutes of Health (NIH) and directed by Drs. Arick and Silman, 74 percent of children diagnosed with hearing loss from persistent OME were restored to normal hearing after seven weeks of treatment with the EarPopper, compared to only 24 percent of the control group. After extending the treatment for four weeks in patients who did not recover within the first seven weeks, the total recovery for the study group was 85 percent. The results will be published in two parts in the Ear, Nose and Throat Journal in September and October 2005.

In addition to OME, the EarPopper treats Eustachian Tube Dysfunction, Aerotitis and Barotitis. Eustachian tube dysfunction can cause development of negative pressure in the middle ear due to a lack of ventilation and lead to an uncomfortable, "blocked" feeling in one or both ears. Aerotitis/Barotitis is a result of negative pressure in the ear caused by rapid ascent or descent (as in an airplane or during scuba diving).

If used early enough, the EarPopper could avoid antibiotic or surgical treatments in many patients suffering from these ear-related issues. In recent years, concerns have increased that frequent use of antibiotics for common ear conditions could raise the possibility that children will harbor drug-resistant bacteria during subsequent, unrelated illnesses. At the same time, many doctors and parents want to avoid the risks of surgery. Each year more than 700,000 children undergo surgery to insert tubes in their ears at an estimated cost of $2,000 per procedure. Complications reduce the effectiveness of ear tubes as they commonly fall out within four to seven months. After the tubes fall out, 40 percent of patients experience a recurrence of OME, and more than half of them must undergo repeat surgery to replace the tubes.

The EarPopper will be manufactured and marketed by Micromedics, Inc. of St. Paul, Minn. and will be available at the end of September 2005.

(a) Experts at The American Academy of Pediatrics, The American Academy of Otolaryngology-Head and Neck Surgery and the American Academy of Family Physicians recommend a "watchful waiting" approach-observation for a period of three months to allow time for the fluid to clear naturally-rather than the traditional use of antibiotics, unless the child is at immediate risk for speech, language or hearing problems.

About Micromedics

Micromedics, Inc. was founded in 1982. The Company develops, manufactures and markets a number of proprietary devices for surgery including implants and instruments for ear, nose and throat surgery, cassettes for organizing and protecting surgical instruments during sterile reprocessing and applicators for biomaterials. The Company also serves as an outsource developer and manufacturer of products for other medical device companies. The Company markets its products and services through a worldwide network of independent representatives and stocking distributors. To learn more about Micromedics products, visit our Web site at www.micromedics.com or call us at 800-624-5662.