HealthDay News — The US Food and Drug Administration has approved a new balloon device to treat Eustachian tube dysfunction.
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% of participants given the device had normal Eustachian tube test results 6 weeks after the procedure, compared with 14% who were treated with a conventional nasal spray. The most common adverse events 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, California-based Acclarent Inc.
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction [news release]. Silver Spring, MD: US Food and Drug Administration; September 16, 2016.