ACCLARENT AERA^®Eustachian Tube Balloon Dilation System

The Acclarent AERA^® Eustachian Tube Balloon Dilation System was the first device in the U.S. specifically designed to dilate the Eustachian tube for patients with persistent ETD.

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Instructions for Use

Features & Benefits

The Acclarent commitment

Acclarent is committed to offering training and support to help you successfully treat ETD. Treatment with the ACCLARENT AERA^® device may allow more patients to regain normal ear function than with medical management alone.¹

From individual support to practice management, our commitment includes:

Training the specialist on the system
Supporting the specialist in making this new treatment option available
Providing the physician practice with education

Designed for safety

The first product of its kind, ACCLARENT AERA^® was specifically designed for the Eustachian tube anatomy with flexibility to reach the source of the problem in a minimally invasive way.

Mechanism of action

Pathology lies within the cartilaginous segment of the Eustachian tube. Histopathology research has demonstrated that balloon dilation may:

Shear or crush portions of the epithelium; usually sparing the basal layer and allowing for rapid healing
Crush lymphocytes and lymphoid follicle
Combined, these effects reduce overall inflammatory burden and may be the underlying reason for lasting clinical improvement in Eustachian tube dilation and ventilation.²

Demonstrated to be effective and safe for ETD patients

The ACCLARENT AERA^® balloon dilation procedure was studied using a prospective, randomized clinical trial.¹

ETD and your patients

Studies indicate that prevalence of ETD among adults in the United States is estimated to be 4.6%.⁴

Identifying appropriate patients

Clinically demonstrated to add benefit compared to medical management in patients with persistent Eustachian tube dysfunction (ETD).

Supporting Documentation

Brochure

ACCLARENT AERA^® Eustachian Tube Balloon Dilation System Brochure

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Questionnaire

The Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

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References

Poe D, Anand V, Dean M, et al. (2017). Balloon dilation of the Eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. Sep 20. doi: 10.1002/lary.26827.
Kivekäs I, Chao WC, Faquin W, et al. (2015). Histopathology of balloon-dilation Eustachian tuboplasty. Laryngoscope. 125(2):436-441.
Ockermann, T., Reineke, U., Upile, T., Ebmeyer, F., Sudhoff, H.H. (2010). Balloon Dilatation Eustachian Tuboplasty: A Clinical Study. Laryngoscope, 120:1411–1416.
Shan A, Ward BK, Goman AM, et al. Prevalence of Eustachian Tube Dysfunction in Adults in the United States. JAMA Otolaryngol Head Neck Surg. 2019;145(10):974-975.

Disclosures

Important Safety Information:

ACCLARENT AERA^® Eustachian Tube Balloon Dilation System 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.

Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This content is intended for audience within the US only.

109360-220311

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended for visitors from the United States.

ACCLARENT AERA® Eustachian Tube Balloon Dilation System