SBIR Phase I: Simplified Pneumatic Otoscopy

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project, if successful, is an improvement in diagnosis and treatment of middle ear infections, a disease that affects greater than 90% of the world's population. Middle ear infections are the leading cause of hearing loss in children and responsible for more surgeries than any other childhood disease. Correct diagnosis of fluid in the middle ear space is crucial to proper treatment to avoid extended hearing loss. The American Academy of Pediatrics recommends pneumatic otoscopy as a key diagnostic for the identification of fluid in the middle ear, yet only 25% of physicians even attempt this exam because it is difficult to obtain a seal of the ear canal, which is a requirement for the technique. Over-prescription of antibiotics has become a significant problem, leading to antibiotic resistance and wasted resources. This project will prove the concept of a pneumatic otoscopy technique that does not require a seal of the ear canal, leading to a much simpler, yet equally effective exam. This will, in turn, lead to increased compliance with the academy-recommended guidelines and improved patient outcomes. The proposed project will develop tools to improve the success rate of pneumatic otoscopy, enabling physicians to comply with the guidelines set forth by the American Academy of Pediatrics and to better diagnose and treat otitis media with effusion. In pneumatic otoscopy, a physician views the surface of the eardrum while changing the pressure in the ear canal to cause the eardrum to move. If the middle ear is filled with fluid, then the eardrum does not move appreciably. The proposed tools will leverage thermodynamic principles in novel ways to abolish the requirement of sealing the canal. They will be low-cost, enabling access to the technology even for the solo practitioner. The proposed project will (1) design and build prototypes of these tools, (2) characterize the tools on a lab bench, and (3) characterize the tools in a simulation model of the human ear. The project will culminate in data that teaches whether or not the proposed tools will suitably inform the physician about the presence of fluid in the ear.