Device for Otitis Media Diagnosis

OtoNexus正在开发世界上第一个医疗设备，以提供明确的，客观的诊断数据， 快速准确地诊断儿童和成人的中耳感染，称为中耳炎。 这个快速跟踪建议解决了确定流体的性质背后的临床困难， 急性中耳炎（Acute Otitis Media - AOM）中的鼓膜（鼓膜）。临床 研究表明，年轻医生的错误率（假阴性、假阳性）平均为50%。准确 AOM的检测依赖于检测和表征中耳液。经验丰富的考官意识到 即使当使用气动耳镜检查时，它们也在至少20%的情况下出错。 在美国，医疗从业者每年诊断1760万例中耳炎，花费超过50亿美元。 我们目前的诊断方法已经有几十年的历史了，非常主观，而且效率极低。因此，委员会认为， 中耳炎既是儿童抗生素处方的头号适应症，也是儿童中耳炎手术的头号原因。 孩子每年有667，000名15岁以下的儿童接受鼓膜造口管， 所有的门诊手术过度诊断OM导致的过度抗生素治疗可导致 抗生素耐药性、显著的副作用和增加的药物成本。诊断不足会导致感染 进展，可能需要手术或有永久性听力损失的风险。 我们建议使用多普勒超声（DUS）来判断鼓膜（TM）的振动 在扰动膜位置之后。膜流动性随着流体粘度的增加而降低。DUS 允许对这种移动性进行快速和系统的评估。申报器械可由医生使用， 助理一样。DUS数据可以很容易地确认中耳积液的存在并估计其性质。 本项目是确定评估TM移动性的最有效参数的基本步骤 并因此确定中耳积液的存在和特征（阶段I），然后将该装置集成到一个 适合测试和商业化的手持式外形规格（第二阶段）。TM型运动将 通过DUS使用新型换能器观察，以评估模型中耳的内容物，并引导 发展信号处理来区分膜迁移率。该设备预计将增加 预后准确性，大大消除了诊断的不确定性和由此产生的抗生素过度处方， 减少不必要的专家转诊，减少听力损失损害的情况， 在孩子见到的第一个临床医生手中就能准确诊断OM。

OtoNexus is developing the world’s first medical device to provide definitive, objective diagnostic data for the rapid and accurate diagnose middle ear infections, called Otitis Media, in children and adults. This FAST TRACK proposal addresses the clinical difficulty of determining the nature of fluid behind the tympanic membrane (ear drum) in acute infection of the middle ear (Acute Otitis Media - AOM). Clinical studies show that error rates (false negative, false positive) among young physicians average 50%. Accurate detection of AOM depends on detecting and characterizing middle ear fluid. Experienced examiners realize they err in at least 20% of cases even when pneumatic otoscopy is used. Medical practitioners diagnose 17.6M cases of Otitis Media each year at a cost of more than $5 billion in the US. Current diagnostic methods are decades old, highly subjective, and extremely ineffective. Consequently, Otitis Media is both the #1 indication for antibiotic prescriptions in children and the #1 cause for surgery for children. Each year, 667,000 children under 15 receive tympanostomy tubes, accounting for more than 20% of all ambulatory surgery in this group. Excessive antibiotic treatment from over-diagnosis of OM can lead to antibiotic resistance, significant side effects, and increased drug costs. Under-diagnosis can allow the infection to progress, potentially requiring surgery or risking permanent hearing loss. We propose to use Doppler Ultrasound (DUS) to judge the oscillation of the tympanic membrane (TM) after perturbing the membrane position. Membrane mobility is reduced with increasing fluid viscosity. DUS permits a fast and systematic evaluation of this mobility. The proposed device can be used by physician and assistant alike. DUS data can readily affirm the presence of middle ear effusion and estimate its nature. The present project is the basic step to determine the most efficient parameters for assessing TM mobility and therefore the presence and character of middle ear effusion (Phase I), and then integrate the device into a hand-held form factor suitable for testing and commercialization (Phase II). Model TM motions will be observed by DUS with a novel transducer to assess contents of the phantom middle ear, and guide the development of signal processing to distinguish membrane mobility. The device is expected to increase prognostic accuracy, largely eliminate diagnostic uncertainty and resultant over-prescription of antibiotics, reduce unnecessary specialist referrals, reduce instances of hearing loss damage, and place the tools for accurate diagnosis of OM into the hands of the very first clinician the child sees.