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

这项小企业创新研究（SBIR）二期项目的更广泛影响/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岁之前至少会患一例中耳炎。尽管它很流行，但在绝大多数病例可见的初级保健中，诊断准确率可能低于60%。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科和外科转诊。中耳炎的典型诊断是使用耳镜检查鼓膜（鼓膜）并评估感染的视觉迹象。自19世纪以来，耳镜的设计几乎没有变化。SBIR二期项目提出了一种新型设备，该设备将临床标准耳镜检查与一种新型技术相结合，利用光实时无创评估耳健康状况，准确率达到98%。这种新型耳镜有可能在中耳炎的诊断和管理方面创造新的护理标准，并通过更准确的诊断节省数十亿美元的直接医疗保健费用。这个小企业创新研究（SBIR）二期项目将推进一种设备的翻译，为临床医生在标准耳镜检查期间提供一个客观、实时的耳朵健康指标。按下按钮，LED驱动的测量将提供一个即时，准确的指示是否存在中耳积液(MEE) -根据既定临床指南，急性中耳炎最敏感和最具体的指标。该项目将满足所需的技术规范，具有足够灵敏的可视化能力，并将测量时间从1.4秒减少到300毫秒以下。该项目还将：1)优化可制造性和装配；2)开发标准的自动校准系统；3)为安全和监管目的进行标准的电子、光生物学和生物相容性测试。该奖项反映了美国国家科学基金会的法定使命，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.