Device for Otitis Media Diagnosis

中耳炎诊断装置

• 批准号: 9486576
• 负责人: Mark A Moehring
• 金额: $ 40.37万
• 依托单位: OTONEXUS MEDICAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9486576
• 关键词: Academy; Accounting; Acute; Address; Adult; Adverse effects; Air; Ambulatory Surgical Procedures; American; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Child; Childhood; Chronic; Clinical; Clinical Research; Code; Custom; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Errors; Diagnostic Procedure; Doppler Ultrasound; Drug Costs; Ear; Elements; Enrollment; Environment; Evaluation; External Ear; External auditory canal; Grant; Graph; Guidelines; Hand; Health Care Costs; Health Professional; Industry Standard; Infant; Infection; Inflammation; Lead; Liquid substance; Measurement; Mechanics; Medical; Medical Device; Membrane; Modeling; Motion; Nature; Nurses; Operative Surgical Procedures; Organism; Otitis Media; Otitis Media with Effusion; Otoscopy; Output; Painless; Patients; Pediatrics; Perforation; Performance; Phase; Physician Assistants; Physicians; Positioning Attribute; Program Development; Research; Resistance; Response to stimulus physiology; Risk; Signal Transduction; Specialist; Speed; System; Technology; Testing; Time; Transducers; Tube; Tympanic membrane; Tympanostomy; Tympanostomy Tube Insertions; Ultrasonic Transducer; Ultrasonography; Uncertainty; Viscosity; Visit; accurate diagnosis; base; commercialization; cost; design; detector; diagnostic accuracy; ear infection; effusion; engineering design; experience; experimental study; hearing impairment; instrumentation; middle ear; novel; outcome forecast; phantom model; preference; pressure; primary caregiver; prognostic; programs; prototype; rapid diagnosis; research clinical testing; signal processing; success; tool; usability

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.

Otonexus正在开发世界上第一种为提供确定的客观诊断数据的医疗设备 儿童和成人中的快速准确的中耳感染，称为中耳炎。 这个快速的提议解决了确定流体本质的临床难度 中耳急性感染（急性中耳炎-AOM）中的鼓膜膜（耳鼓）。临床 研究表明，年轻医生的错误率（假阴性，假阳性）平均为50％。准确的 AOM的检测取决于检测和表征中耳流体。经验丰富的考官意识到 即使使用气动性耳镜，它们在至少20％的情况下会犯错。 医生每年诊断为176万例中耳炎病例，费用超过50亿美元 我们。当前的诊断方法已有数十年历史，高度主观且极其无效。最后， 中耳炎既是儿童抗生素处方的＃1指示，也是手术的第一名 孩子们。每年，15岁以下的667,000名儿童接受鼓膜造口管，占20％以上 该组的所有门诊手术。 OM过度诊断的过度抗生素治疗可能导致 抗生素耐药性，重大副作用和药物成本增加。诊断不足会允许感染 进步，可能需要手术或冒着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）的振荡 扰动膜位置后。随着流体粘度的增加，膜迁移率降低。 dus 允许对此移动性进行快速而系统的评估。建议的设备可以由Buthyanian和 助理。 DUS数据可以很容易地肯定中耳泡沫的存在并估计其性质。 本项目是确定评估TM移动性最有效参数的基本步骤 因此，中耳积液的存在和特征（I期），然后将设备集成到A 手持式形式适用于测试和商业化（II期）。 TM Motions将是 用新型换能器观察到dus，以评估幻影中耳的含量，并指导 信号处理的开发以区分膜迁移率。该设备有望增加 预后准确性，在很大程度上消除了诊断性不确定性，并导致抗生素的过度处方 减少不必要的专家推荐，减少听力损失损害的实例，然后放置工具 将OM的准确诊断到孩子看到的第一位临床医生的手中。