Acclarent, a subsidiary of Johnson & Johnson ($JNJ), received FDA de novo clearance to begin marketing its Aera eustachian tube balloon dilation system developed to treat persistent eustachian tube dysfunction (ETD).
The de novo classification is the regulatory agency’s pathway to approval for novel, low- to moderate-risk medical devices that are the first of their kind.
The Aera system uses a balloon catheter that can be inserted through a patient’s nose into their eustachian tube, where it is inflated and then removed, the agency said. A pathway is then created that allows mucus and air to pass, restoring correct function and reducing the pressure, pain and clogging typically associated with the condition.
“The eustachian tube supports hearing by maintaining pressure inside the ear,” Dr. Malvina Eydelman, director of the Division of Ophthalmic and Ear, Nose and Throat devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “The Aera Eustachian Tube Balloon Dilation System is a new treatment option for patients with ETD symptoms.”
Results from a randomized clinical trial of 299 patients with chronic ETD used to gain the clearance showed that 52% of the patients that got the Aera system had tympanogram results within a normal functioning range 6 weeks after the procedure, versus 14% of the patients who were treated only with conventional medical management (nasal spray).
Adverse events associated with the Aera system are small tears of the lining of the eustachian tube, minor bleeding and worsening of ETD. The FDA said the system shouldn’t be used on patients younger than 22, of if they have a carotid artery that protrudes through a gap in the bone surrounding the eustachian tube or if their eustachian tube is always open (patulous eustachian tube).