An estimated 60,000 mastoidectomies and 150,000 tympanoplasties are performed each year throughout the U.S, with published failure rates ranging from 3% to 26%[1-3]. One cause of failure is initial mucosalization in place of epithelialization at the wound site, leading to mucosalization of the mastoid cavity and tympanic membrane, with tympanic membrane perforation, mastoiditis, or otitis media as possible sequelae. According to Giner?s otolaryngologist consultants, Drs. Elizabeth Toh and Peter Weber, some form of the previous scenarios occurs in almost 100% of patients post-surgery, typically healing after 6 to 12 weeks under the current standard of post-surgical care ? packing the ear and using anti-biotic drops to prevent infection. For the approximate 10-20% of patients whose inflammatory process does not resolve, a surgical revision may be necessary. Drs. Toh and Weber believe that one possible way to decrease recovery time, dry the middle ear sooner by encouraging epithelialization over mucosalization, and prevent a revision surgery is to provide concentrated oxygen to the wound site. Giner has developed a miniature Electrochemical Oxygen Generator (EOG) under previous NIDDK funding for a bio-artificial pancreas; this proven technology would be further reduced in size and integrated into a hearing aid shell. Giner will also continue development of a self-regulating EOG and dosage control electronics to operate the device in order to provide a constant flow rate to the wound site. Additionally an ear piece will be developed that will provide a path for oxygen entry into the ear. The objective of this Phase I SBIR is to create 10 wearable Ear Oxygenation Devices (EODs), each with their own electronics and ear piece. These devices will be operated in vitro for a minimum of 15 weeks to demonstrate compatibility with the current recovery time, plus a safety margin.
Patients undergoing middle ear surgeries experience the wound site being covered with mucus, possibly leading to mucus in the mastoid cavity, ear drum perforation, or infections of the middle ear or mastoid cavity, any of which may necessitate to a repeat surgery. This project seeks to improve wound healing by providing concentrated oxygen to the wound, thereby encouraging normal healing over mucosalization and preventing a repeat surgery. This project will build on Giner?s proven miniature Electrochemical Oxygen Generator (EOG) technology, developed under Grant No. 2R44DK100999-02, and Self Regulating EOG and dosage control electronics, developed under Grant No. 1R43DK113536-01, to develop a wearable Ear Oxygenation Device.
