Efficacy of balloon dilation of the eustachian tube in eustachian tube dilatory dysfunction: a randomized, sham-controlled trial

Participation Requirements

• Sex:

  Male, Female, Intersex

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:
There are two categories of eligible patients for this study; those with chronic eustachian tube dysfunction, and those with eustachian tube dysfunction in the context of altitude/pressure changes (baro-challenge eustachian tube dysfunction).

For those with chronic eustachian tube dysfunction, one must have at least 3 months of symptoms, failure of at least 4 weeks of intranasal steroids, documented abnormal tympanogram (specifically type As, B, or C), and they must score above or equal to 2.1 on a eustachian tube dysfunction questionnaire (ETDQ7).

For those with baro-challenge eustachian tube dysfunction, they must have had barometric-induced symptoms at least every 4 months within the last year, these symptoms must resolve within 3 days of pressure equalization, and they must have failed a trial of topical/oral decongestant, pneumatization device, or pressure relief ear plugs.
Exclusion Criteria:
1. Patulous eustachian tube dysfunction
2. Presence of ear drum perforation, ear tube, or severe retraction
3. Meniere’s disease
4. Uncontrolled sinus disease, reflux, TMJ disorder, immunodeficiency, or allergies
5. Known dehiscence of the internal carotid artery in the bony eustachian tube
6. Recent head and neck surgery or planned procedure during study period
7. History of radiation to the head and neck
8. History of craniofacial abnormality
9. Prior eustachian tube intervention
10. Psychiatric condition or cognitive impairment precluding capacity to consent