August 22, 2017
Chad Ahn, MD, board-certified otolaryngologist, was the first physician in Central Kentucky to use the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System to treat Eustachian Tube Dysfunction (ETD).
In September 2016, Acclarent, Inc. announced the U.S. availability of the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System, the first balloon dilation intervention approved by the U.S. Food and Drug Administration (FDA) for Eustachian Tube Dysfunction (ETD). ACCLARENT AERA™ is the only balloon dilation device that offers a minimally-invasive option to treat the source of ETD, a condition often marked by ear pain, pressure and dulled hearing.
“Eustachian tube dilation is a novel, safe technique for addressing chronic Eustachian Tube Dysfunction in adults,” said Dr. Ahn. “Patients experience minimal to no discomfort during the procedure, and are able to return to work and normal activities the next day.”
ETD is a condition that affects approximately one percent of adults.1 Eustachian tubes are typically responsible for equalizing pressure in the middle ear, but when the tube is not functioning properly, patients may feel pain, pressure, or a sense of fullness or clogging. People with ETD may also experience hearing loss or ringing in the ear. Previously, ETD was treated with medications or surgery with ear tubes, one of the most commonly performed of all operations. However, failure to correct the underlying problem could lead patients to develop chronic symptoms, persistent complaints or more serious conditions such as middle ear effusion, infections and related long-term complications.
ACCLARENT AERA™ leverages the company’s innovative balloon catheter technology to dilate dysfunctional Eustachian tubes by inserting a small balloon into the tube and inflating the balloon. The device also offers the necessary flexibility to adapt to Eustachian tube anatomy to help ear, nose and throat (ENT) surgeons minimize trauma through precise access and positioning.
Results from clinical studies demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated. Studies also found a greater rate of tympanogram normalization than control subjects treated with medical management alone (51.8 vs. 13.9 percent), as well as a greater improvement in quality of life measures. Additionally, there were zero reported serious device- or procedure-related adverse events.2