Feasibility of an Innovative Absorbable Ventilation Tube Designed to Provide Intermediate-Term Middle Ear Ventilation: Clinical Human Proof-of-Concept
Myringotomy with ventilation tube placement is a common surgical procedure performed in children and adults to remove fluid build-up behind the tympanic membrane. However, retention of tubes beyond achievement of therapeutic response increases risk for complications and additional intervention. This small feasibility study was conducted to demonstrate proof-of-concept of a novel bioabsorbable ventilation tube (BVT) that provides the necessary duration of ventilation with absorption shortly thereafter in human adult patients. BVTs were placed in 15 ears of 14 patients meeting indications for short or intermediate-duration of middle ear ventilation. Two independent examiners documented eardrum status. BVT patency and BVT absorption status at 3, 6, and 12 week intervals until absorption was complete. Results indicate that average ventilation time was 12 weeks (range 3 weeks to 18 months). There was no observation of blockage. These findings support the safety and utility of a novel bioabsorbable ventilation tube.