The Food and Drug Administration (FDA) has permitted the marketing of a novel balloon device, The Aera Eustachian Tube Balloon Dilation System (Acclarent), to treat persistent Eustachian tube dysfunction (ETD).
“Restoring function to this important part of the middle ear may provide relief from the pain, discomfort and sensation of ear fullness or blockage associated with ETD. The Aera Eustachian Tube Balloon Dilation System is a new treatment option for patients with ETD symptoms,” said Malvina Eydelman, MD, and the FDA director of the Division of Ophthalmic and Ear, Nose and Throat devices.
The Aera treatment involves a doctor using a catheter to insert a small balloon through the patient’s nose and into the Eustachian tube, which when inflated, opens a pathway for mucus and air flow. Once the tube is dilated the doctor deflates and removes the balloon.
The FDA marketing permission was based on results from a randomized clinical trial of 299 patients with chronic ETD. Fifty-two percent of the patients who underwent the Aera procedure had tympanogram results within normal functioning range six-weeks later, compared to 14% of patients who were treated with conventional medical management (nasal spray).
The review was conducted via the FDA’s de novo classification process for novel, low- to moderate-risk, first-of-kind medical devices.
For more information visit FDA.gov.