Acclarent Inc. recently launched its Acclarent Aera Eustachian Tube Balloon Dilation System in the U.S. to treat Eustachian Tube Dysfunction (ETD).
This is the first balloon dilation intervention for ETD that the U.S. Food and Drug Administration (FDA) has approved. It is also the only balloon dilation device that serves as a minimally invasive option for ETD.
"Health care providers treating ETD frequently see ear infections, pressure or blockage, or complaints such as hearing loss and pain," Dr. Dennis Poe, professor of otolaryngology at Harvard Medical School and Boston Children's Hospital, said. "As discussed at the recent American Academy of Otolaryngology annual meeting, doctors do their best to treat these conditions, but until now -- with the launch of Acclarent Aera -- options did not address the root of the problem with the Eustachian tube itself."
Approximately 1 percent of adults have ETD, which occurs when Eustachian tubes don’t properly equalize the pressure within the middle ear. ETD causes patients to experience ear pressure, pain and dulled hearing.
"We are excited to be first to launch an FDA-approved device in the United States that will help otolaryngologists directly restore physiologic Eustachian tube function and middle ear ventilation," Dr. William Kane, medical director at Acclarent, said. "The device is built on Acclarent's pioneering technologies and provides physicians with a minimally invasive and clinically superior option for treating ETD that goes beyond managing the symptoms."
