Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)

The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.

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