ACCLARENT AERA® Eustachian Tube Balloon Dilation System Instructions for Use. Irvine, CA: Acclarent, Inc.; 2018. IFU005146 Rev E.
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Indications For Use
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 18 and older.
Important Safety Information
ACCLARENT AERA® is intended for use by physicians who are trained on Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
View ACCLARENT AERA® Instructions for Use