New EarPopper ENT Eustachian Tube Ear Canal FDA Device

Description

This auction is for a BRAND NEW Summit Medical EarPopper Eustachian Tube Device. This is the model EP3000 and comes with 10 Disposable Nose Pieces.  The EarPopper is a safe, simple, non-surgical, non-drug related prescription device for treating such common conditions as Otitis Media with Effusion, Aerotitis/Barotitis (caused by rapid elevation changes), and Eustachian Tube Dysfunction in children and adults. Perfect for any Ear Nose and Throat Specialist, Family Practice Doctor or Pediatrician. Please call us at with any questions or concerns you may have about the use of this new treatment device. This device is for medical professionals and can only be purchased by a physician or by a patient with a prescription.
A clinical study has demonstrated that negative pressure in the middle ear can be relieved by use of the EarPopper. Often relief will occur after only one treatment. Based on the Politzer Maneuver, the EarPopper delivers a safe, constant, regulated stream of air into the nasal cavity. During the moment of swallowing the air is diverted up the Eustachian tube clearing and ventilating the middle ear. The EarPopper relieves negative ear pressure and allows any accumulated fluids to drain.
CONDITIONS TREATED:
- Fluid in the Middle Ear (Otitis Media with Effusion/Middle Ear Effusion)
- Eustachian Tube Dysfunction can cause development of negative pressure in the middle ear due to a lack of ventilation and can lead to Otitis Media with Effusion, Aerotitis/Barotitis.
- Aerotitis/Barotitis is a result of negative middle ear pressure caused by rapid elevation changes (airplane, diving, mountain climbing, etc.).
QUESTIONS and ANSWERS:
Does it work?
Yes - a two part clinical study funded by NIH (National Institutes of Health) was recently published in the September and October 2005 issues of the scientific journal - Ear, Nose and Throat Journal. This study showed an efficacy rate of around 85% in the patients who used the EarPopper treatment.
What does it do?
The middle ear is a closed, air filled chamber that is normally ventilated by the Eustachian tube. The middle ear is separated from the outer ear by the ear drum. Under some circumstances, pressure in the middle ear can become higher or lower than the pressure in the outer ear. This condition can cause hearing loss, severe pain and, in some cases, cause fluid to accumulate in the middle ear. The EarPopper equalizes pressure in the middle ear by opening the Eustachian tube.
Who are candidates for treatment?
Children and adults diagnosed with fluid in the middle ear, airplane passengers or divers who have problems adjusting to changes in elevation, persons with Eustachian tube dysfunction, etc.
How does it work?
The Ear Popper directs a steady, controlled stream of air into the nose. Swallowing diverts the air into the Eustachian tube, opening the Eustachian tube and relieving pressure imbalance in the middle ear. (The effectiveness of this technique was originally discovered by Dr Adam Politzer in the nineteenth century).
How is it used?
The user places the EarPopper firmly against one nostril, blocks his/her other nostril, activates the device, and swallows while the device is running. For simple pressure imbalance, relief can be instantaneous. When fluid is present, the treatment is repeated twice in each nostril, twice a day and is recommended for seven weeks or until the hearing returns. The actual treatment needs to be prescribed by a physician.
Is it safe? Could air pressure damage the ear?
The EarPopper is extremely safe. A recent clinical study funded by NIH (National Institutes of Health) was conducted on children and demonstrated the safety and efficacy of the device. There is no pressure in the ear until swallowing occurs. During swallowing, the pressure in the ear is controlled by the device at a very safe level. The total duration of pressure is less than one second.
Does it hurt?
The familiar "popping" of the ears is caused by the opening of the Eustachian tube during swallowing. This is nature's own way of relieving pressure imbalance in the middle ear. The sensation of the ear "popping" during the EarPopper treatment is important because it indicates the treatment is working. The popping can be experienced as ranging from practically no sensation at all to a momentary mild feeling of pressure. The EarPopper has different settings to accommodate different tolerances of the sensation. Most of the children in the clinical study tolerated the sensation very well. Many even thought it was fun.
Balkowitsch Enterprises, Inc.
Shane Balkowitsch, RN
Authorized EarPopper Distributor
"The sale if this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."
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