Acclarent received FDA Clearance for AERA Eustachian Tube Balloon Dilation System

Johnson and Johnson Medical Companies asserted that Acclarent,Inc which is a leader in developing minimally-invasive Ear, Nose and Throat technologies has sought clearance from the U.S Food and Drug Administration to augment the indication  for the Acclarent AERA Eustachian Tube Balloon Dilation System.

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.

Acclarent AERA is the 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.

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 stated “The device provides a minimally invasive option for ear, nose and throat surgeons to treat persistent ETD at its source.”