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

这项小型企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是改善小儿中耳炎（耳部感染）的诊断。 中耳炎是儿童不必要使用抗生素的主要原因，也是第二常见的儿科医生预约。 据估计，超过90%的儿童在5岁之前会遭受至少一例中耳炎。 尽管其流行，但在初级保健中诊断准确率可能低于60%，其中绝大多数病例都被发现。 目前的临床诊断已被证明不足以解决抗生素的过度处方和不必要的专家和手术转诊。中耳炎通常使用耳镜来诊断，以观察鼓膜（耳膜）并评估感染的视觉体征。 耳镜的设计自1800年以来变化不大。 该SBIR第二阶段项目推进了一种新型设备，该设备将临床标准耳镜检查与一种新技术相结合，利用光线以真实的时间和98%的准确率非侵入性地评估耳部健康。 这种新型耳镜有可能在中耳炎的诊断和管理方面创造一种新的护理标准，并通过更准确的诊断节省数十亿美元的直接医疗成本。这个小型企业创新研究（SBIR）第二阶段项目将推进设备的翻译，为临床医生提供标准耳镜检查期间耳朵健康的客观实时指标。 按下按钮，LED驱动的测量将提供一个即时的，准确的指示是否存在中耳积液（中耳积液）-最敏感和具体的指标急性中耳炎根据既定的临床指南。 该项目将满足足够灵敏的可视化能力的预期技术规格，并将测量时间从1.4秒减少到不到300毫秒。 该项目还将：1）优化可制造性和组装; 2）开发标准自动校准系统; 3）出于安全和监管目的进行标准电子、光生物学和生物相容性测试。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.