SBIR Phase II: Finalized Design, Performance and Safety Testing of SmartOto, A Handheld Device for Detection of Otitis Media

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve diagnosis of pediatric otitis media (ear infection). Otitis media is the leading cause of unnecessary antibiotic use in children and the second most common pediatric physician appointment. It is estimated that more than 90% of children will suffer at least one case of otitis media before age 5. Despite its prevalence, there may be less than 60% diagnostic accuracy in primary care where the vast majority of cases are seen. Current clinical diagnostics have proven inadequate to address over-prescription of antibiotics and unnecessary specialist and surgical referrals. Otitis media is typically diagnosed using an otoscope to view the tympanic membrane (eardrum) and assess visual signs of an infection. Otoscope designs have changed little since the 1800’s. This SBIR Phase II project advances a novel device that integrates clinical standard otoscopy with a novel technique to non-invasively assess ear health using light in real time and with 98% accuracy. This new otoscope has the potential to create a new standard of care in diagnosis and management of otitis media, and stands to save billions in direct healthcare costs through more accurate diagnosis. This Small Business Innovation Research (SBIR) Phase II project will advance translation of a device providing clinicians with an objective, real-time indicator of ear health during standard otoscopy. At the push of a button, the LED driven measurement will provide an instantaneous, accurate indication of the presence or absence of middle ear effusion (MEE) – the most sensitive and specific indicator of acute otitis media per established clinical guidelines. This project will meet the desired technical specifications of sufficiently sensitive visualization capabilities and reducing measurement time from 1.4 seconds to less than 300 milliseconds. This project will also: 1) Optimize manufacturability and assembly; 2) Develop a standard automated calibration system; and 3) Conduct standard electronic, photobiologic, and biocompatibility testing for safety and regulatory purposes. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.