Acclarent out of Irvine, California is releasing in the U.S. its ACCLARENT AERA eustachian tube balloon dilation system, the first such product for treatment of eustachian tube dysfunction. Eustachian tubes, which link the pharynx to the middle ear and are used to regulate pressure when we yawn, sneeze, and swallow food, can get blocked and result in poor hearing, discomfort, and pain. Often ear tubes are inserted to create a passage for air to flow through, but these don’t actually fix the problem with the eustachian tubes, sometimes leading to further problems.
The ACCLARENT AERA can be used to deliver the deflated balloon into an eustachian tube and to carefully inflate it. The flexible distal end helps to insert the balloon component and the balloon’s flexibility allows it to move into the lumen. Once inflated, the lumen of the eustachian tube is dilated and its natural functionality is restored.
Some numbers from studies performed using the ACCLARENT AERA, according to the company:
Results from clinical studies demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated. Studies also found a greater rate of tympanogram normalization than control subjects treated with medical management alone (51.8 vs. 13.9 percent), as well as a greater improvement in quality of life measures. Additionally, there were zero reported serious device- or procedure-related adverse events.