Project Summary Otitis media (OM) is the leading cause of healthcare visits in the world, affecting more than 700 million people worldwide1 and accruing a significant economic burden of over $5 billion annually in direct and indirect costs in the US alone2. Children are particularly susceptible to this disease; 90% of children will contract OM by the age of five3,4, with 40% of cases eventually becoming recurrent or chronic5. The gold standard for treatment of recurrent acute OM and chronic OM with effusion is myringotomy surgery with tympanostomy tube insertion, in which a small tube is inserted into the tympanic membrane to ventilate and drain fluids out of the middle ear. Nearly 700,000 children in the US are treated with tympanostomy tubes (TTs) annually. To help resolve infection and prevent otorrhea, tube insertion is commonly supplemented with a regimen of topical antibiotics. However, due to their lumen geometry and material composition, existing TTs are not optimized for reliable delivery of drugs into the middle ear and frequently become occluded by cellular debris, pathogenic bacteria, blood, and pus. Such challenges hinder OM treatment and prompt invasive TT replacement surgeries in up to 20% of children with TTs.6 To combat these challenges simultaneously, PionEar Technologies Inc. is developing tympanostomy tubes (PionEar TTs) with a patent-pending material design that synergistically reduces the pressure barrier for drugs to penetrate into the middle ear and suppresses bioadhesion, thus maximizing the therapeutic benefit of topical drugs and facilitating earlier eradication of infection. Novel bio-inspired PionEar TTs possess (1) precisely engineered lumen geometry that is optimized to promote spontaneous transport of therapeutics even without tragal pumping, and (2) slippery liquid-infused materials that further minimize contact line pinning while suppressing bioadhesion7–9. PionEar tubes are biocompatible and non-ototoxic, minimally invasive, and simple-to-manufacture. They preserve critical functionality of existing tympanostomy tubes: to enable ventilation and drainage of the middle ear and prevent water from entering the middle ear.10,11 In an SBIR Phase I, we propose to assess the in vivo performance of PionEar tubes for promoting more efficient drug delivery and resolution of OM compared to commercial tubes in a gold-standard OM chinchilla model. Demonstration of proof-of-concept will prepare the technology for successful Phase II application and future commercialization. If successful, PionEar TTs would alleviate the prevalent issue of recurrent ear infections and complications, and open up new avenues for the treatment of OM. PionEar Technologies Inc. was born out of three years of rigorous translational medicine research and collaboration between Harvard’s Wyss Institute, J.A. Paulson School of Engineering and Applied Sciences, and Massachusetts Eye and Ear. Its novel TT technology was awarded the Grand Prize at the Collegiate Inventors Competition by NIHF and USPTO as well as five other prestigious awards.

Project Narrative Middle ear infections, also known as otitis media, are the leading cause of healthcare visits in the world, affecting more than 700M people globally, and accruing significant economic burden of over $5B in direct and indirect costs each year in the US alone. The gold standard for treatment of recurrent acute ear infections and chronic OM with effusion is myringotomy surgery with tympanostomy tube insertion, in which millimeter-scale tubes are inserted into the eardrum to ventilate and drain fluids out of the middle ear; unfortunately, current state-of-the-art tympanostomy tubes are not ideal for OM treatment, as they commonly become contaminated by cells and pathogens and do not reliably promote delivery of topical therapeutic drugs into the middle ear. In an SBIR Phase I, PionEar Technologies, Inc. will demonstrate a proof-of-concept for an innovative, fluid-guiding tympanostomy tube that promotes rapid elution of therapeutic drugs into the middle ear, thus enabling faster resolution of OM in vivo in a preclinical chinchilla model.