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.


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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.

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Reference

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.