What Is Eustachian Tube Dilation?
Eustachian tube balloon dilation (also called balloon tuboplasty) is a surgical technique designed to treat obstructive Eustachian tube dysfunction by dilating the cartilaginous portion of the tube. By inserting and inflating a balloon catheter within the Eustachian tube, the procedure aims to restore normal tube function, improve middle ear ventilation, and relieve symptoms such as ear fullness, pressure, and hearing loss. It offers an alternative for patients who have failed medical treatments but wish to avoid repeated tympanostomy tubes or chronic ear complications. To learn more about Eustachian tube dysfunction, read this article.
Indications for Eustachian Tube Dilation
1. Chronic Eustachian Tube Dysfunction
Patients with persistent Eustachian tube dysfunction (ETD), typically lasting more than 3 months and unresponsive to nasal steroids, antihistamines, and autoinflation, are candidates. Symptoms include chronic aural fullness, fluctuating hearing loss, and tympanometric evidence of negative middle ear pressure.
2. Barochallenge-Induced Dysfunction
This form affects individuals who experience ear pain, pressure, or effusion primarily during rapid altitude changes (e.g., flying or diving), while having relatively normal function at ground level. These patients are often not good candidates for an ear tube placement, whether because they are divers (tubes are contraindicated), or because they are frequent swimmers for example.
Example 2:
A 35-year-old airline pilot experiences severe ear pain and difficulty clearing ear pressure during descent but remains symptom-free between flights. Examination and tympanometry are normal at rest. He meets criteria for balloon dilation to prevent barotrauma and improve Eustachian tube function under stress.
Steps of the Surgery
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Anesthesia: Usually performed under local anesthesia, where the nose and nasopharynx (back of the nose) are frozen and decongested. Sometimes, a general anesthesia can an option in select cases.
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Endoscopic Access: A nasal rigid endoscope (camera) is introduced to visualize the opening of the Eustachian tube in the nasopharynx.
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Balloon Catheter Insertion: A flexible catheter with a deflated balloon is guided into the cartilaginous portion of the Eustachian tube (the portion closest to the back of the nose).
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Dilation: The balloon is inflated to a pressure of approximately 10-12 atm for 1-2 minutes, mechanically expanding the walls of the Eustachian tube.
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Deflation and Removal: The balloon is deflated and withdrawn, leaving no device behind.
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Post-Procedure Care: Patients are typically discharged the same day with nasal sprays and instructions for gentle autoinflation after healing.
The Balloon Dilation Device and Available Models
The balloon catheter is a narrow, flexible device typically 5-7 mm in diameter when inflated and about 16 mm in length. The balloon exerts radial (outward) pressure on the cartilaginous Eustachian tube, promoting mechanical expansion and possibly remodeling (changes in the fibrous layer of the tube, and changes at the levels of the cells composing the tube).
Regulatory History
The first Eustachian tube balloon dilation device, Acclarent Aera, was approved by the FDA in the United States in 2016, after trials demonstrated safety and efficacy. As a result, this procedure is relatively new.
Available Models in Canada include the Acclarent Aera (one of the first devices approved in the U.S), the Spiggle & Theis Tubavent (a German system available in Europe and Canada, offering a slightly different balloon length and flexibility), the Entellus Medical XprESS, now part of Stryker (a multi-sinus dilation system also used for Eustachian tubes in select centers) and more recently the Medtronic NuVent balloon (also derived from a multi-sinus dilation system). While they each have their particularities, all can effectively dilate the Eustachian tube.
Risks vs Benefits of Eustachian Tube Dilation: What Does The Evidence Show?
Benefits:
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Minimally invasive: Performed endonasally without external incisions. The procedure takes about 30-60 minutes including preparation.
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Durable long-term relief of ear pressure/fullness: Studies report symptom improvement lasting at least up to 3 years and possibly more (Poe DS, et al. 2018). 83% of patients maintain normalized middle ear pressure for 2+ years, reducing reliance on decongestants or antibiotics (Cutler, et al., 2019).
- Improved quality of life
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Reduced need for ear tubes: Especially in adults with chronic ETD, repeated middle ear fluid or/and barochallenge dysfunction. By avoiding the use of ear tubes, the risk of ear infections during swimming is significantly reduced. This is a significant advantage, especially in frequent swimmers or people with susceptible ears. Additionally, there is no danger of eardrum perforations or long-term damage to the eardrum when additional tubes are required.
- Ideal when ear tubes are contraindicated: Divers are among the patients who benefit most from this procedure because ear tubes are not recommended for them. This is due to the risk of water entering the ear, which can cause vertigo—a dangerous condition when underwater.
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Natural Solution: No foreign objects (like ear tubes) left in the body.
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Structural Remodeling: Balloon dilation initiates changes at the cellular level within the connective tissue (the "structure") of the Eustachian tube. This process helps to address the underlying cause of the tube's collapse, providing a more permanent solution rather than just alleviating the symptoms like an ear tube.
Risks:
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Bleeding or mucosal injury: Minor and usually self-limited.
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Infection: Low risk, mitigated by perioperative antibiotics.
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Failure to improve symptoms: Seen in a minority (~up to 10%).
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Rare complications: Include submucosal emphysema or carotid injury (extremely rare with correct technique). Sometimes, over-inflated can lead to patulous Eustachian tube (the tube being too open)
Summary of Evidence
Clinical trials and systematic reviews have generally supported the use of balloon dilation in select patients with ETD. Below are some of the largest studies demonstrating the efficacy of the procedure:
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Poe DS et al. (2011): The first multicenter trial showing significant improvement in symptoms and tympanometric outcomes.
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Meyer TA et al. (2018): A randomized controlled trial demonstrating symptom relief and improved quality of life at 6 and 12 months post-procedure.
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Munsterman ID et al. (2018): Systematic review showing success rates around 70-80% in chronic ETD cases.
However, long-term data beyond 5 years is still limited, and ongoing studies aim to refine the ideal patient profile.
Joe Saliba, MD
Dr. Joe Saliba is an ENT surgeon specialized in neuro-otology and medical director at ODYO. He treats patients with various ear and skull base disorders, ranging from hearing loss and vertigo to vestibular schwannomas and cochlear implants.
