The standard of care for Eustachian tube dysfunction is myringotomy and tympanostomy tube placement. Tympanostomy tube placement has become one of the most common otolaryngological procedures performed today. Postoperative otorrhea remains the most common complication of tympanostomy tube placement. This has been attributed to water, and bacteria, entry into the middle ear via the conventional patent tympanostomy tube lumen. To ventilate the middle ear, the tympanostomy tube creates a constantly open tympanic membrane when it normally is closed. Patients are often advised to take precautions during common activities involving water exposure, such as bathing, showering, and swimming.

In this present study, a modification was made to the external flange of a tympanostomy tube to prevent water entry, by attaching a biocompatible, hydrophobic, gas permeable membrane. Modified tympanostomy tubes and test systems to evaluate them were developed. Oxygen flow testing confirmed that the biocompatible membrane allowed air to pass through. A fluid-filled syringe and pressure gauge system allowed for testing various water column pressures and verifying that the modified tube was indeed able to prevent water entry. The final modified tubes were assembled, packaged, and sterilized for a future clinical trial pilot study.