Dilation Device Treats Persistent Eustachian Tube Dysfunction

A novel dilation system uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pain and other sensations affect the ear.

The Aera Eustachian tube system consists of a balloon catheter that is inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated for two minutes to open up a pathway for mucus and air to flow through, in order to restore proper function and reduce pressure, pain, or clogged or muffled sensations in the ear. After the Eustachian tube is dilated, the balloon is deflated and removed. The most common adverse events are small tears of the lining of the Eustachian tube, minor bleeding, and worsening of ETD.

In a study involving 299 patients with chronic ETD, 52% of the patients treated with the Aera system had a subsequent normal functioning range as measured by a tympanogram, a method used to measure mobility of the ear drum and pressure inside the ear. The positive results were fourfold higher than in patients treated with conventional medical management using nasal sprays. The Aera system is a product of Acclarent (Menlo Park, CA, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

“The Aera Eustachian tube balloon dilation system is a new treatment option for patients with ETD symptoms,” said Malvina Eydelman, MD, director of the ophthalmic & ENT device division at the FDA Center for Devices & Radiological Health (CDRH). “The Eustachian tube supports hearing by maintaining pressure inside the ear. 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 Acclarent Aera offers a minimally-invasive and promising option for patients suffering from Eustachian tube dysfunction," said Juha Silvola, MD, PhD, a consultant in Otology-Otoneurology at Oslo University Hospital (Norway). “In my initial experiences with the Aera, the device enabled me to safely and successfully dilate my patients' Eustachian tubes.”

The Eustachian tube is a narrow passage leading from the pharynx to the cavity of the middle ear, permitting the equalization of pressure on each side of the eardrum. 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.

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Oslo University Hospital