The FDA, on September 16, 2016, permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The Aera Eustachian Tube Balloon Dilation System is manufactured by Acclarent, Inc. of Irvine, CA.
The Eustachian tube connects the middle ear to the back of the throat. It is normally filled with air and helps maintain equal pressure inside the ear with the surrounding environment by periodically opening and closing, like a valve. If this function is impaired, as is the case with ETD, it results in discomfort, impaired hearing, persistent ear infections, ringing in the ears (tinnitus) or other symptoms.
“The Eustachian tube supports hearing by maintaining pressure inside the ear,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat devices in the FDA’s Center for Devices and Radiological Health. “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.”
With the Aera system, a doctor uses a catheter to insert a small balloon through the patient’s nose and into the Eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through the Eustachian tube, which may help restore proper function. After the Eustachian tube is dilated, a doctor deflates and removes the balloon. The FDA reviewed the Aera system through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.
The FDA reviewed data on the Aera system from a randomized clinical trial of 299 patients with chronic ETD. Participants’ middle ear function was tested using a tympanogram, a method of measuring mobility of the ear drum and pressure inside the ear. Of the patients who underwent the Aera system procedure, 52 percent had tympanogram results within a normal functioning range six weeks after the procedure, compared to 14 percent of the patients who were treated only with conventional medical management (nasal spray).
The most common adverse events associated with the Aera system are small tears of the lining of the Eustachian tube, minor bleeding and worsening of ETD. Patients under the age of 22, patients who have a carotid artery that protrudes through a gap in the bone surrounding the Eustachian tube or patients whose Eustachian tube is always open (patulous Eustachian tube) should not use the Aera system.
See the FDA Announcement