ABOUT THE OTTER CLINICAL STUDY
The OTTER study is a clinical trial to evaluate the ability to perform ear tube placement for children in the doctor's office.
In the investigational study, the Ear, Nose & Throat (ENT) doctor will place the iontophoresis system ear plug into the ear. The iontophoresis system uses a small amount of electrical current to push a numbing medicine into the ear drum. Once the ear drum is numb, the doctor inserts the tube delivery system into the ear. The tube delivery system is used to make a cut in the eardrum and place the tube in one quick step.
The study includes up to 7 visits to the doctor’s office:
- a screening evaluation before the procedure,
- the investigational procedure, and
- follow-up visits at 3 weeks, 6, 12, 18, and 24 months.
The screening and post-procedure visits will include evaluations of your ear.
Consult with a study doctor for complete information regarding study evaluations, potential risks and benefits.