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

This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals:Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunctionIdentify patient variables associated with positive response to balloon dilation of the eustachian tubeRe-demonstrate the safety of balloon dilation of the eustachian tubeWhat does participation in this study involve? Participants in this study will:Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks laterAgree to allowing the investigators access to their personal health informationComplete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure:A questionnaire to assess your eustachian tube dysfunctionAn assessment of the movement of your ear drum (tympanogram)A hearing test (audiogram)A questionnaire to assess the impact of eustachian tube dysfunction on work/activityA questionnaire to assess overall health-related quality of lifeAn assessment of the ability to equalize middle ear pressure(s)Visual examination of the ear drumsRepeat the above assessments and questionnaires at 6-, 12-, 24-, and 52-weeks after the dilation procedure.

Inclusion Criteria (Chronic ETDD):>3 months of symptoms of ETDD (otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged) persistent at enrollmentPersistence of symptoms despite >4 weeks INCS or >7d course of systemic steroid within 6 months from enrollmentDocumented Type B or C tympanogram at or within 6 months from enrollmentETDQ7 ≥ 2.1 at enrollmentInclusion criteria (baro-challenge ETDD):>12 months of baro-challenge induced symptoms occurring at least every 4 months within the past yearSymptoms 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 TM perforation or tympanostomy tubeFluctuating SNHL, AOM, or tympanosclerosis of >50% of the TMUncontrolled sino-nasal disease, reflux, TMJ disorder, immunodeficiency, or allergiesKnown ICA dehiscence of the bony ET of the symptomatic earRecent head and neck surgery within the past 3 months or planned procedure during studyHistory of radiation to the head and neckHistory of craniofacial abnormalityPrior ET interventionPsychiatric condition or cognitive impairment which precludes capacity to consent.