Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Inclusion Criteria: * Adult male or female aged 22 years and older * Persistent Eustachian tube dysfunction * Failure of medical management * Positive diagnosis of ETD * Absence of internal carotid artery (ICA) dehiscence * Able to read and understand English Exclusion Criteria: * Females who are pregnant or lactating * Anatomy that requires an adjunctive surgical procedure * Concomitant nasal or sinus procedures planned on the same day as surgical procedure * Concomitant ear procedures planned on the same day as surgical procedure * History of major surgery of the head or neck within four (4) months prior to surgery * History of patulous ET * History of fluctuating sensorineural hearing loss * Active acute otitis media * Tympanic membrane perforation * Tympanosclerosis * Acute upper respiratory infection * Temporomandibular joint disorder * Cleft palate * Craniofacial syndrome * Cystic fibrosis * Ciliary dysmotility syndrome * Systemic mucosal or immunodeficiency disease * Intolerance of medication for ETD * Prior intervention of Eustachian tube