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# FDA Approves Device for Clogged Ear Disorder
- URL: https://www.fdaweb.com/fda-approves-device-for-clogged-ear-disorder/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136825

FDA has approved an Acclarent *de novo* petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The device allows a physician to use 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, which may help restore proper function. After the eustachian tube is dilated, a doctor deflates and removes the balloon.

Approval was based on data from 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% had tympanogram results within a normal functioning range six weeks after the procedure, compared to 14% of the patients who were treated only with conventional medical management (nasal spray),” an agency [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM521063?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says.  

The most common adverse events seen with the device 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 should not use the device, FDA says.