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EarPopper™ Immediately
Restores Hearing, Resolves Middle Ear Fluid without Antibiotics or Tubes
New Device Treats one of the Top Reasons for Doctor Visits Among Children
Saint Paul, Minnesota – September 19, 2005 - 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*,
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™ 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 earrelated 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.
* 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.
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For More Information, Contact:
Kammi Stout, Marketing Communications Coordinator
Micromedics, Inc
800-624-5662, extension 292
888-504-0606 (fax)
kstout@micromedics.com
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