FDA Approves Balloon Device for Eustachian Tube Dysfunction
Designed to relieve pressure, pain, or clogged or muffled sensations occuring in the ear
FRIDAY, Sept. 16, 2016 (HealthDay News) -- A device that uses a small balloon to treat Eustachian tube dysfunction has been approved by the U.S. Food and Drug Administration.
The Aera Eustachian Tube Balloon Dilation System enables doctors to insert a catheter through the nose into the Eustachian tube, where a small balloon is inflated and creates a path for mucus and air. The balloon is then deflated and removed.
In clinical trials, 52 percent of participants given the device had normal Eustachian tube test results six weeks after the procedure, compared with 14 percent who were treated with a conventional nasal spray. The most common side effects included Eustachian tube puncture, minor bleeding, and worsening Eustachian tube dysfunction.
The device shouldn't be used by patients under age 22, among those whose Eustachian tube is always open, or among patients in whom the carotid artery protrudes through a gap in the bone that surrounds the Eustachian tube.
The device is produced by Irvine, Calif.-based Acclarent Inc.