The Eustachian tube is the main connection between the back of the throat and the middle of the ear. Normally, the tube is filled with air and opens when yawning or chewing. “This allows you to equalize pressure” on either side of the eardrum, explained David Kaylie, MD, a Duke otolaryngologist. When the tube is blocked from a cold or sinus, nose or ear infection, air can no longer pass through. Stuffy ears and noses, hearing loss, ear pain and pressure, as well as ringing in the ears (tinnitus) can result.
Blocked Eustachian tubes can be relieved by nasal sprays and antihistamine tablets, which reduce inflammation and congestion. Recurrent Eustachian tube dysfunction requires the surgical placement of tubes in the eardrum, which allows pressure to equalize in the middle ear. Now that the FDA has approved the Aera system, children, and adults with chronic Eustachian tube dysfunction, can opt for a simple, 10-minute procedure instead, Kaylie said.
“This new device has been shown to return the middle ear to normal and greatly eliminate middle ear pressure in properly selected patients,” he said. Studies of the device showed “long term normal Eustachian function after the procedure.”
David Kaylie, MD, performs the minimally invasive procedure in the OR, but no overnight stay is required.
During the minimally invasive procedure, a catheter is used to insert a small balloon through the nose and into the Eustachian tube. The balloon is inflated, which opens the Eustachian tube and allows air to flow through. Once the tube is open, the balloon is deflated and removed.
While Kaylie believes the device will prove useful to many people who currently require ear tube surgery due to Eustachian tube dysfunction, fluid in their ears, or chronic ear infections, he also cautions that there are some people for whom it will not be appropriate. During the clinical trial for the Aera system, some common problems included small tears in the lining of the Eustachian tube, minor bleeding and, sometimes, worsening or their Eustachian tube dysfunction.
Still, Kaylie believes it will be a significant advance for the millions of people who require ear tube surgery. “There are people who need tubes 13 or 14 times,” he said. “Every time the tubes come out, they need the tubes in again. There is a huge need for this procedure, and it will greatly reduce the need for all those ear tubes” and other related surgeries.