DESCRIPTION
Balloon dilation of the eustachian tube (e.g., AERA® Eustachian Tube Balloon Dilation System, TubaVent™ Balloon Catheter, XprESS™ ENT Dilation System) is proposed to improve patency in individuals with eustachian tube dysfunction. The eustachian tube (ET) connects the middle ear space to the nasopharynx and ventilates the middle ear space to equalize pressure across the tympanic membrane, clear mucociliary secretions, and protect the middle ear from infection and reflux of nasopharyngeal contents. The eustachian tube opens during swallowing or yawning. 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.
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 two minutes after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.
POLICY
Balloon dilation of the eustachian tube is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Balloon dilation of the eustachian tube for the treatment of all other conditions is considered investigational.
MEDICAL APPROPRIATENESS
Balloon dilation of the eustachian tube is considered medically appropriate if ALL of the following are met:
Adult 18 years of age or older
Symptoms of chronic obstructive eustachian tube dysfunction (e.g., otalgia, hearing loss) including ALL of the following:
Aural fullness
Aural Pressure
Symptoms lasting 3 months or longer that are continuous and not episodic (e.g., symptoms occur only in response to barochallenge such as pressure changes while flying)
Condition significantly affects quality of life or functional health status
Documentation of ALL of the following:
Nasal endoscopy
Tympanometry
Comprehensive audiometry, with ALL the following findings:
Abnormal tympanogram (Type B or C)
Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam)
Failure to respond to appropriate medical management of coexisting conditions (e.g., allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux)
Other causes of aural fullness have been ruled out. (e.g., temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence, and endolymphatic hydrops)
Absence of ALL the following:
Patulous eustachian tube dysfunction
Craniofacial syndrome (i.e., cleft palate)
Neoplasm causing extrinsic obstruction
History of the radiation therapy to the nasopharynx
Enlarged adenoid pads
Nasopharyngeal mass
Neuromuscular disorders that lead to hypotonia/ineffective eustachian tube dynamic opening
Documentation shows reversibility of eustachian tube dysfunction when individual performs Valsalva maneuver. (e.g., popping ears)
No previous history of having balloon dilation of the eustachian tube
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Individuals undergoing balloon dilation of the eustachian tube (BDET) concurrent with sinus ostial dilation should meet the same diagnostic criteria for BDET as those undergoing BDET alone. Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.
SOURCES
American Academy of Otolaryngology - Head and Neck Surgery. (2019). Clinical consensus statement: balloon dilation of the eustachian tube. Retrieved October 7, 2020 from https://www.entnet.org/content/clinical-practice-guidelines.
BlueCross BlueShield Association. Evidence Positioning System. (10:2022) Balloon dilation of the eustachian tube (7.01.158). Retrieved September 7, 2023 from www.bcbsaoca.com/eps/. (16 articles and/or guidelines reviewed)
Cutler, J.L., Meyer, T.A., Nguyen, S.A., O’Malley, E.M., Thackeray, L., & Slater, P.W. (2019). Long-term outcomes of balloon dilation for persistent eustachian tube dysfunction. Otology & Neurotology, 40 (10),1322-1325. Abstract retrieved October 31, 2019 from PubMed database.
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)
Froehlich, M.H., Le, T.P., Nguyen, S.A., McRackan, T.R., Rizk, H.G., Meyer, T.A. (2020). Eustachian tube balloon dilation: A systematic review and meta-analysis of treatment outcomes. Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 163 (5), 870-882. Abstract retrieved October 7, 2020 from PubMed database.
Krogshede, S.K., Kirchmann, M., Jorkov, APS., & Glad, H. (2022). Balloon dilation of the eustachian tube: A randomized controlled trial with 6 months follow-up. The Journal of International Advanced Otology, 18(6), 501-506. (Level 2 evidence)
National Institute for Health and Care Excellence. (2019, December). Balloon dilatation for chronic eustachian tube dysfunction. Retrieved October 7, 2020 from www.nice.org.uk.
Poe, D., Anand, V., Dean, M., Roberts, W., Stolovitzky, J., Hoffmann, K. et al. (2018). 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.
Satmis, M. & van der Torn, M. (2018). 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 Assessment. (2021, February; last update search April 2023). Eustachian tube balloon dilation for the treatment of chronic eustachian tube dysfunction in adults. Retrieved September 7, 2023 from www.hayesinc.com/subscribers. (58 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 10/12/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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