The Audion ET dilation system Indications for Use: To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

A physician using Audion for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use XprESS for Eustachian tube dilation does not meet at least one of these criteria, please contact your Stryker representative to arrange training.

The most common side effects associated with the use of Audion for Eustachian Tube dilation include: pain, tissue inflammation, damage to the Eustachian Tube and continued or worsening symptoms. Potential severe risks include: subcutaneous emphysema and carotid artery damage.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Federal (USA) law restricts this device to sale by or on the order of a physician.

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. We do not dispense medical advice and recommend that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate Stryker’s products. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your representative if you have questions about the availability of Stryker’s products in your area.

Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: Stryker and Audion. All other trademarks are trademarks of their respective owners or holders.

The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.

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