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: This health technology assessment focuses on ET balloon dilation (ETBD) with the Bielefeld balloon catheter, which is also referred to as the Bielefelder Ballonkatheter, Bielfeld, Bielefeld device, BET-Catheter, or, most recently, TubaVent balloon catheter. The overall length is 400 millimeters (mm), with a working length of 355 mm from the Luer connection to the distal tip. The balloon is 3 × 20 mm in size. With a pressure of 6 bar, the balloon expands to 3.00 mm; with a pressure of 10 bar, the diameter is 3.28 mm. The flexible distal portion of the catheter is coaxial in structure. Inflation is performed through the outer lumen. The stainless steel proximal portion of the catheter is a single-lumen tube.

Patient Population: The Bielefeld ETBD System is intended to dilate the ET for treatment of chronic ETD in adults.

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. Other balloon devices available in the United States include the Aera ETBD System, Balloon Sinuplasty System, and Relieva Solo Balloon Catheter (Acclarent Inc.) and the Entellus Xpress. 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.

If you have a Hayes login, click here to view the full report on the Knowledge Center.