What is Eustachian Tube Balloon Dilation?
The ACCLARENT AERA™ Eustachian Tube Balloon Dilation System is the first device in the US indicated to dilate the Eustachian tube. The ACCLARENT AERA™ system uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.
With the ACCLARENT AERA™ system, a doctor uses a catheter to insert a small balloon through the patient’s nose and into the Eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through the Eustachian tube, which may help restore proper function. After the Eustachian tube is dilated, a doctor deflates and removes the balloon.
Eustachian Tube Balloon Dilation Results
- 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.
- 56.1% vs. 8.5% improvement in the Quality of Life measure from the Eustachian Tube Dysfunction Questionnaire (ETDQ-7).
- Additionally, there were zero reported serious device- or procedure-related adverse events.