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# FDA Clears Expanded Use for Acclarent Inner Ear Device
- URL: https://www.fdaweb.com/fda-clears-expanded-use-for-acclarent-inner-ear-device/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140860

FDA has cleared an Acclarent 510(k) to expand the indication for the Acclarent Aera Eustachian Tube Balloon Dilation System to include its use in patients as young as 18\. The device was previously cleared only for adults aged 22 and older. In addition, the company says recent evidence shows the procedures may be performed with local or topical anesthesia, whereas before, only general anesthesia had been studied. Eustachian tube dysfunction is a blockage of the narrow tube that connects the throat to the middle ear, and helps the ears drain fluid and equalize pressure. “The device leverages flexible technology to adapt to variations in ear anatomy to help ear, nose and throat surgeons minimize trauma through precise access and positioning,” the company says.