Delayed-Start Study Design for Balloon Dilation of the Eustachian Tube: Alternative for a Randomized Controlled Trial

The Eustachian tube (ET) is a narrow canal that courses from the middle ear cavity to the nasopharynx, which opens to provide ventilation to the middle ear and to equalize middle ear and ambient pressures (1). In this article, we refer by “Eustachian tube dysfunction” only to obstructive ET dysfunction, i.e., failure to open and ventilate the middle ear, as opposed to patulous ET dysfunction, in which there is failure of ET closure. ET dysfunction is a common medical problem with an estimated incidence of 1% in the adult population and produces symptoms of aural fullness, otalgia, tinnitus, and hearing loss, often exacerbated or precipitated by atmospheric pressure changes (2, 3). Upper airway inflammation (including allergic rhinitis and chronic rhinosinusitis) commonly precipitate (episodes of) obstructive ET dysfunction (1). Long-lasting ET dysfunction may also result in middle ear conditions such as serous otitis media, tympanic membrane (TM) retractions, and cholesteatoma (4).