Clinically proven with patients with persistent Eustachian tube dysfunction (ETD)

Patient inclusion criteria used to determine if a patient was a potential candidate with persistent ETD for admission into "A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)”.

Clinical evidence study methodology

The study was a prospective, multicenter, randomized, controlled trial to demonstrate superiority of the Eustachian tube balloon dilation with Eustachian tube balloon catheter in conjunction with medical management compared to medical management alone.

Diagnosis and main criteria for inclusion

  • Subjects age 22 and older diagnosed with persistent ETD.
  • Persistent ETD is defined by patient-reported symptoms of ETD for 12 weeks or greater.
  • Failure of medical management consisting of either a minimum of 4
    weeks of continuous daily usage of any intranasal steroid spray or a
    minimum of one completed course of an oral steroid.
  • Patients were required to have a computed tomography (CT) scan to confirm absence of internal carotid artery (ICA) dehiscence in the ET lumen.
  • An abnormal tympanometry (type B or C) after failed medical
  • Demonstrated symptomatic dysfunction as documented through a
    validated quality of life instrument (ETDQ-7) with a score ≥ 2.1 after
    failed medical management.

    Downloadthe Eustachian Tube Dysfunction Questionnaire


It was the first FDA-cleared balloon dilation intervention for ETD with a prospective, multicenter, randomized clinical trial.


Contact your local
representative or call
877-775-2789 if you are
a physician interested in
learning more about
Tube Balloon Dilation System training.

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It is ultimately up to the healtcare provider's discretion to diagnose appropriate patients.

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