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 iontophoresis system pushes the numbing medicine into the ear drum

The iontophoresis system pushes the numbing medicine into the ear drum

 

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.

 The tube delivery system deploys the tube into the ear drum

The tube delivery system deploys the tube into the ear drum