Balloon dilation of the eustachian tube is a procedure proposed to improve the patency by inflating a balloon (e.g., AERA® Eustachian Tube Balloon Dilation System, TubaVent™ Balloon Catheter, XprESS™ ENT Dilation System) in the cartilaginous part of the eustachian tube to cause it to dilate. The eustachian tube (ET) connects the middle ear space to the nasopharynx. The ET ventilates the middle ear space to equalize pressure across the tympanic membrane, clears mucociliary secretions, and protects the middle ear from infection and reflux of nasopharyngeal contents. The ET opens during swallowing or yawning. During the balloon dilation procedure, a saline-filled balloon catheter is introduced into the eustachian tube through the nose using a transnasal endoscope. Pressure is maintained for approximately 2 minutes after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.
Eustachian tube dysfunction occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure can be due to anatomic abnormalities, or more frequently to inflammation and can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo. Chronic dysfunction can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas.
Balloon dilation of the eustachian tube for treatment of individuals with eustachian tube dysfunction is considered investigational.
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The durability of effect, rates of reoperation or revisions, and safety data over the first year are needed. The current published evidence is insufficient to determine the effects of the technology on health outcomes, therefore this technology remains investigational.
BlueCross BlueShield Association. Evidence Positioning System. (2:2018) Balloon dilation of the eustachian tube. Retrieved October 12, 2018 from http://www.evidencepositioningsystem.com. (15 articles and/or guidelines reviewed)
ECRI Institute. Product Brief. (2018, March) Acclarent aera eustachian tube balloon dilation system (Acclarent, Inc.) for treating persistent eustachian tube dysfunction. Retrieved October 12, 2018 from ECRI Institute. (10 articles and/or guidelines reviewed)
National Institute for Health and Care Excellance. (2011, November) Balloon dilatation of the eustachian tube. Retrieved October 12, 2018 from www.nice.org.uk.
Poe, D., Anand, V., Dean, M., Roberts, W., Stolovitzky, J., Hoffmann, K. et al. (2018, May) Balloon dilation of the eustachian tube for dilatory dysfunction: a randomized controlled trial. Laryngoscope, 128 (5), 1200-1206. Abstract retrieved October 12, 2018 from PubMed database.
Stamis, M. and van der Torn, M. (2018, February). Balloon dilatation of the Eustachian tube in adult patients with chronic dilatory tube dysfunction: a retrospective cohort study. European Archives of Otorhinolaryngology, 275 (2), 385-400. Abstract retrieved October 12, 2018 from PubMed database.
U. S. Food and Drug Administration. (2017, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K163509. (XprESS ENT Dilation System). Retrieved October 12, 2018 from http://www.fda.gov.
U. S. Food and Drug Administration. (2017, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K171761. (AERA® Eustachian Tube Balloon Dilation System). Retrieved October 12, 2018 from http://www.fda.gov.
Winifred S. Hayes, Inc. Health Technology Brief. (2017, July; last update search July 2018). Acclarent eustachian tube balloon dilation for the treatment of chronic eustachian tube dysfunction in adults. Retrieved October 12, 2018 from www.hayesinc.com/subscribers. (29 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Brief. (2017, July; last update search July 2018). Bielefeld eustachian tube balloon dilation for the treatment of chronic eustachian tube dysfunction in adults. Retrieved October 12, 2018 from www.hayesinc.com/subscribers. (30 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 3/2/2019
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