SBIR Phase I: Simplified Pneumatic Otoscopy

这个小型企业创新研究(SBIR)第一阶段项目如果成功，其更广泛的影响/商业潜力将是中耳感染的诊断和治疗方面的改进，中耳感染是一种影响世界90%以上人口的疾病。中耳感染是导致儿童听力损失的主要原因，与其他儿童疾病相比，中耳感染导致的手术次数更多。正确诊断中耳间隙积液是正确治疗以避免扩大听力损失的关键。美国儿科学会建议将气动耳镜检查作为识别中耳积液的关键诊断，但只有25%的医生尝试过这种检查，因为很难获得耳道的密封，而这是一项技术要求。抗生素的过度处方已经成为一个严重的问题，导致抗生素耐药性和资源浪费。这个项目将证明气动耳镜技术的概念，这种技术不需要密封耳道，从而导致一种简单得多，但同样有效的检查。这反过来将导致对学院推荐的指南的更高遵从性，并改善患者结果。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，医生在改变耳道内的压力以使耳膜移动的同时观察鼓膜的表面。如果中耳充满液体，那么鼓膜就不会有明显的移动。拟议中的工具将以新的方式利用热力学原理来取消密封运河的要求。它们将是低成本的，即使是单独的从业者也能够获得技术。拟议的项目将(1)设计和建造这些工具的原型，(2)在实验室工作台上对工具进行表征，以及(3)在人耳的模拟模型中对工具进行表征。该项目将最终得出数据，告诉医生所建议的工具是否会适当地告知医生耳朵中存在液体。

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.