FDA Clears Expanded Indication of Acclarent AERA® Eustachian Tube Balloon Dilation System

ENT company, Acclarent, Inc., has received U.S. FDA clearance to expand the indication for the Acclarent AERA® Eustachian Tube Balloon Dilation System to include its use in patients as young as 18. The device was previously cleared only for adults aged 22 and older.


Eustachian Tube Dysfunction (ETD) is a blockage of the narrow tube that connects the throat to the middle ear, and helps the ears drain fluid and equalize pressure. The condition, which affects up to 5 percent of adults, is often marked by ear pain, pressure in the ears, and dulled or loss of hearing. Previously, ETD was treated with medication, or surgery with ear tubes. However, failure to correct the underlying problem may lead some patients to develop chronic symptoms, persistent complaints or more serious conditions such as middle ear effusion, infections and related long-term complications.

Johnson & Johnson company, Acclarent, Inc., describes itself as a leader in the development of minimally-invasive Ear, Nose & Throat (ENT) technologies. The Acclarent AERA® is the first and only device specifically designed to help treat patients with persistent ETD. The device leverages flexible technology to adapt to variations in ear anatomy to help ear, nose and throat surgeons minimize trauma through precise access and positioning.

In addition to the news about the expanded age range, the company points to recent evidence shows the procedure may be performed with local and/or topical anesthesia (before, only general anesthesia had been studied). The use of local anesthesia may provide benefits including cost savings and time efficiencies for suitable patients.

More than 9,000 patients have been treated with the Acclarent AERA® since it was first granted clearance by the FDA in 2016.

Physician comments

“This expanded indication of Acclarent AERA®, and the data regarding the procedure under local anesthesia, will help expand treatment options and bring relief to more patients with persistent ETD,” said Dr. Marc Dean, a board-certified otolaryngologist in private practice and the cofounder and chairman of the Vitruvio Institute for Medical Advancement in Fort Worth, Texas. “The device provides a minimally invasive option for ear, nose and throat surgeons to treat persistent ETD at its source.”

Source: Acclarent, Inc.

Share your thoughts

Your email address will not be published. Required fields are marked *