SBIR Phase I: Simplified Pneumatic Otoscopy

如果成功的话，这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是改善中耳感染的诊断和治疗，这种疾病影响了世界90%以上的人口。中耳感染是儿童听力损失的主要原因，比任何其他儿童疾病都要多手术。中耳腔积液的正确诊断对正确治疗至关重要，以避免延长听力损失。美国儿科学会建议将气动耳镜作为识别中耳积液的关键诊断方法，但只有25%的医生甚至尝试过这种检查，因为很难获得耳道密封，而这是该技术的要求。抗生素的过度处方已成为一个重大问题，导致抗生素耐药性和浪费资源。该项目将证明气动耳镜技术的概念，不需要密封耳道，导致一个更简单，但同样有效的检查。这将反过来导致增加遵守学术推荐的指南和改善患者的结果。拟议的项目将开发工具，以提高气动耳镜检查的成功率，使医生能够遵守美国儿科学会制定的指南，并更好地诊断和治疗渗出性中耳炎。在气动耳镜检查中，医生观察耳膜表面，同时改变耳道中的压力以导致耳膜移动。如果中耳充满了液体，那么鼓膜不会明显移动。所提出的工具将以新的方式利用热力学原理，以消除密封管道的要求。它们将是低成本的，即使是单独的从业者也能获得技术。拟议的项目将（1）设计和构建这些工具的原型，（2）在实验室工作台上表征工具，以及（3）在人耳模拟模型中表征工具。该项目将最终在数据，教导是否或不建议的工具将适当地通知医生有关液体的存在，在耳朵。

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.