Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

The Eustachian tube is a biological tube that connects the back of the nose to the middle
ear. It is usually closed but needs to be actively opened by the action of certain muscles
during swallowing, yawning, and other activities which keeps the air pressure in the middle
ear (the part of the ear behind the eardrum) the same as the air pressure in the
environment. If the Eustachian tube does not open during swallowing, the middle-ear pressure
progressively decreases and persons may have the feeling of a "stuffed up" and/or "full"
middle ear, may have difficulty hearing and/or may develop fluid in their middle ear.

The usual treatment for a Eustachian tube that does not open well is to insert a tiny tube
(called a ventilation or tympanostomy tube) into the eardrum to keep the air pressure in the
middle ear the same as in the environment. However, those tubes naturally "fall out" over
time, and if the Eustachian tube opening function had not improved while they were in place,
new tubes will need to be inserted. In the past few years, doctors in the U.S. and Europe
described a simple procedure called "balloon dilation of the Eustachian tube" (BDET) or
"balloon tuboplasty" that they believe corrects the underlying cause of Eustachian tube
dysfunction and resolves its symptoms, signs and consequences. For that procedure, a tiny
balloon is inserted into the Eustachian tube, inflated to physically open the Eustachian
tube, deflated and then removed. Doctors who have used the method in adults and children
with symptoms of Eustachian tube dysfunction reported that BDET is safe and causes a
short-term and, perhaps, a long-term resolution of symptoms. However, no one has measured
Eustachian tube function before and after the procedure, and it is not known if BDET truly
improves that function or not, and if so, how that function is changed.

In this study, we will enroll adult subjects with a tympanostomy tube inserted into at least
one eardrum or a chronic perforation in at least one eardrum for physician-diagnosed
Eustachian tube dysfunction or middle-ear fluid and document the presence/absence of
measurable Eustachian tube dysfunction using standard tests. If present, we will determine
if the Eustachian tube dysfunction improves after medical treatment of other diseases known
to cause Eustachian tube dysfunction. If the Eustachian tube dysfunction does not
significantly improve, we will perform the BDET procedure and measure the change in
Eustachian tube function at different times after the procedure.

Inclusion Criteria:

- has functional ventilation tube or a chronic perforation in at least one ear;

- history of Eustachian tube dysfunction and/or otitis media with effusion;

- history of middle-ear effusion at least once;

- otherwise healthy except for possible gastro-esophageal reflux disease (GERD),
allergies, sinusitis;

- BMI of less than 35;

- no history of difficult intubation;

- no known family history of malignant hyperthermia.

Exclusion Criteria:

- history of adverse reaction to any study-related medication and a suitable
alternative is not available;

- current or past history of cancer;

- current or past history of vestibular pathology or cranial base surgery;

- craniofacial dysmorphology (examples: down syndrome, cleft palate);

- pregnancy or "at risk" and not using contraception;

- patulous Eustachian tube;

- non-patent nasal cavity;

- adenoids that block the Eustachian tube orifice;

- blood pressure greater than 140/90;

- had experimental drug or procedure in the previous 3 months;

- allergic to eggs, egg products, soy, or soy products;

- previously underwent balloon dilation of the Eustachian tube.