Balloon Dilation of the Eustachian Tube (BDET)

This is an interventional treatment trial for Eustachian Tube Dysfunction Read More

Inclusion Criteria:

• ≥18 years old (of both sexes)
• Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral

Diagnosis (both required):

i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.

ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).

Exclusion Criteria:

• Patulous eustachian tube
• Prior eustachian tube intervention
• Presence of myringotomy ventilation tube or a tympanic membrane perforation
• Active chronic or acute otitis media
• Chronic otitis media with cholesteatoma
• Fluctuating sensorineural hearing loss or Meniere's disease
• Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication
• History of head or neck surgery within 3 months
• Prior radiation to the head and neck
• Active temporomandibular joint disorders
• Cleft palate or Craniofacial syndrome
• Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies
• Active acute upper respiratory infection
• Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
• CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
• Patient unable to follow protocol for any reason