Eustachian tube dysfunction (ETD) is the inability of the eustachian tube (ET) to ventilate the middle ear, drain secretions, or protect the middle ear from sounds or pathogens in the nasopharynx. ETD is associated with otologic and rhinology symptoms, including tinnitus (ringing in the ears), aural fullness, an inability to equilibrate middle ear pressure, a sensation of being underwater, impaired hearing, pain, and balance problems.
Description of Technology: The Aera Eustachian Tube Balloon Dilation (ETBD) System is the first balloon device approved for ETD in the United States. The Aera device consists of a guidance catheter and a 16 × 6 millimeter (mm) balloon. The blunt-tipped guidance catheter is inserted through the nose and advanced to the ET. The balloon is then advanced through the guidance catheter to the isthmus of the ET, which is at the end of the cartilaginous tissue prior to the bony portion. When the endoscopic marker is visualized at the distal end of the guidance catheter, the balloon is inflated to 12 atmospheres for 2 minutes and then withdrawn.
Patient Population: The Aera ETBD System is indicated for ETBD for the treatment of persistent ETD in adults ≥ 22 years of age.
Clinical Alternatives: Medical alternatives to the management of ETD include decongestants, oral and nasal steroids, antihistamines, pressure equalization methods, nasal douching, and antibiotics. The most common surgical intervention is the insertion of pressure-equalizing tympanostomy tubes, which may be used as short- or long-term treatment. Surgical interventions other than ETBD include transtubal application of fluids, eustachian tuboplasty using a laser or rotary cutting tool, laser coagulation, and myringotomy for direct application of topical steroids.
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