Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

Adult eustachian tube dilatory dysfunction (ETDD) accounts for over 2 million healthcare visits annually. It can cause longstanding negative middle ear pressure which may lead to otitis media with effusion, tympanic membrane retraction, perforation, middle ear atelectasis and cholesteatoma. Despite this, effective treatments for ETDD are unavailable. Recently, balloon dilation of the eustachian tube (BDET) has gained popularity, where the cartilaginous portion of the Eustachian tube undergoes local dilation with balloon inflation. This technique underwent industry-funded clinical trials in the United States demonstrating its safety and it's superiority to medical management. However, these studies are confounded by industry funding and lack of a blinded control group, the latter of which is critical in a condition where patient-reported outcome measures are relied on. Furthermore, the randomized studies to date do not include patients with baro-challenge ETDD, where symptoms are limited to the context of ambient pressure changes. As such, the investigators opted to perform a non-industry-funded, placebo-controlled trial including both chronic and baro-challenge ETDD patients in a Canadian setting.

Potential participants will be identified as possible study candidates with either chronic ETDD or baro-challenge ETDD, who have failed conservative management. At baseline, participants would undergo pure tone audiometry, tympanometry, and otoscopy. An ETDQ7, ad hoc work/activity impairment questionnaire, and EQ-5D-5L questionnaire would be completed. The patient's ability to equalize their middle ear pressure would be assessed by direct visualization of the tympanic membrane as the patient equalizes their middle ear pressure. For patients with baro-challenge ETDD, a baseline ad hoc questionnaire to quantify their symptoms will be completed as well.

Patients would then be randomized into BDET versus placebo groups. Patients in the experimental group undergoing BDET in-office will undergo dilation after anxiolytic pre-medication, nasal decongestion, as well as topical anesthesia of the lateral tympanic membrane, the eustachian tube orifice, and the nasal cavity. Patients randomized to the placebo group would undergo a similar procedure in-office, but without dilation of the eustachian tube. Patients in the experimental group with contraindication to in-office BDET will undergo BDET under general anesthetic in an operating room setting. The participants' first follow-up visit with the surgeon is at 6 weeks post-procedure, where patients in the placebo control group would be offered the option to cross-over into the BDET group. Follow up would also be repeated at 24 weeks and 52 weeks post-procedure.

Inclusion criteria

(Chronic ETDD):

• >3 months of symptoms of ETDD (otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged) persistent at enrollment
• Persistence of symptoms despite >4 weeks INCS or >7d course of systemic steroid within 6 months from enrollment
• Documented Type B or C tympanogram at or within 6 months from enrollment
• ETDQ7 ≥ 2.1 at enrollment

Inclusion criteria

(baro-challenge ETDD):

• >12 months of baro-challenge induced symptoms occurring at least every 4 months within the past year
• Symptoms include otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy, which resolve within 3 days of pressure equalization.
• Failure of at least one of: topical/oral decongestant, pneumatization device, and/or pressure relief ear plugs.

Exclusion criteria

• Signs/symptoms of patulous eustachian tube dysfunction (autophony, tympanic membrane movement with breathing)
• Adjunctive surgical procedure needed (ex. septoplasty, tympanostomy tube)
• Presence of a tympanic membrane (TM) perforation or tympanostomy tube
• Fluctuating SNHL, AOM, grade IV TM retraction, or tympanosclerosis of >50% of the TM
• Uncontrolled sino-nasal disease, reflux, TMJ disorder, immunodeficiency, or allergies
• Known ICA dehiscence of the bony ET of the symptomatic ear
• Recent head and neck surgery within the past 3 months or planned procedure during study
• History of radiation to the head and neck
• History of craniofacial abnormality
• Prior ET intervention
• Psychiatric condition or cognitive impairment which precludes capacity to consent.