Can Consumers and Audiologists Detect Ear Disease Prior to Hearing Aid Use?

描述（由申请人提供）：目前美国食品和药物管理局（FDA）针对寻求购买助听器的成年人的政策平衡了两个可能相互冲突的医疗保健目标：(1)在购买助听器之前通过检测耳部疾病来确保公共安全；(2)使助听器和其他听力保健服务更实惠，更容易获得。两项疾病监测政策的演变反映了这种二分法。FDA首选的监测方法要求消费者在购买助听器前获得医疗评估。这被认为是提供最佳的疾病检测-在听力保健服务的可负担性和可用性降低的潜在成本。虽然形式上不鼓励，但消费者可以放弃医疗评估，从而潜在地增加听力保健服务的可及性-以潜在的代价错过险恶的耳部疾病。FDA的两项规定是相互矛盾的，几乎没有经验证据支持将其作为一项有效的公共卫生政策或为其他疾病监测方法提供信息。当选择医疗豁免时，检测耳部疾病的负担落在消费者和提供助听器的非医生听力保健提供者（例如听力学家或助听器专家）身上。听力学家检测耳部疾病的能力如何？消费者能在多大程度上评估自己患耳部疾病的风险？为了回答NIDCD提出的更广泛的问题，必须解决这两个关键问题：“现有的FDA对助听器采购前医疗评估和许可的要求是否为患者提供了重大保护，还是造成了重大的准入障碍？”我们建议通过开发和测试两种基于问卷的工具——一种以消费者为中心（消费者耳部疾病风险评估或CEDRA），另一种以提供者为中心（提供者耳部疾病风险评估或PEDRA）——的性能，对非医生（消费者，在这种情况下，听力学家）评估耳部疾病风险的能力进行实证评估。它们被设计成易于完成，对耳部疾病的危险因素敏感，并产生一个分数，可以转化为耳部疾病可能性的统计估计。CEDRA将包括重点关注耳部疾病症状识别的问题。PEDRA将包括类似的问题，还将包括梅奥诊所开发的创新数据分析工具，这些工具可以增强对标准听力测试数据中耳科疾病风险因素的识别。在一项涉及美国学术医疗机构的前瞻性、多地点研究中，将根据耳科医生和神经学家的判断来评估基于CEDRA和PEDRA的疾病筛查的准确性。如果发现CEDRA和PEDRA能够准确地筛查耳部疾病，这些工具可能有助于安全地指导消费者决定使用医疗豁免-使助听器在疾病风险较低的情况下更便宜和更容易获得。如果在本研究的最佳条件下使用这些工具无法检测到耳部疾病，则医疗豁免选项的安全性将受到挑战。

DESCRIPTION (provided by applicant): Current United States Food and Drug Administration (FDA) policies for adults seeking to purchase hearing aids balance two potentially conflicting healthcare objectives: (1) ensure public safety by detecting sinister ear disease prior to hearing aid purchase, and (2) make hearing aids and other hearing healthcare services more affordable and available. Two disease surveillance policies have evolved, reflecting this dichotomy. The FDA preferred surveillance method requires that consumers obtain a pre-hearing aid purchase medical evaluation. This is assumed to provide optimal disease detection - at the potential cost of decreased affordability and availability of hearing healthcare services. Although formally discouraged, consumers can waive the medical evaluation, thereby potentially increasing accessibility of hearing healthcare services - at the potential cost of missing sinister ear diseas. The two FDA provisions are contradictory and there is little empirical evidence to support either as an effective public health policy or to inform alternative disease surveillance approaches. When the medical waiver option is exercised, the burden of detecting ear disease falls upon the consumer and the non-physician hearing healthcare provider (e.g. audiologist or hearing aid specialist) who provides the hearing aids. How well can audiologists detect ear disease? How well can consumers assess their own risk for ear disease? These two key questions must be addressed to answer the broader query posed by NIDCD: "Do the existing FDA requirements for medical evaluation and clearance prior to hearing aid procurement provide significant protection to patients or create a significant barrier to access?" We propose to empirically evaluate how well non-physicians (consumers and, in this case, audiologists) can evaluate ear disease risk, by developing and testing the performance of two questionnaire-based tools - one consumer focused (Consumer Ear Disease Risk Assessment or CEDRA) and one provider focused (Provider Ear Disease Risk Assessment or PEDRA). They are designed to be easy to complete, sensitive to ear disease risk factors, and result in a score that can be translated into statistical estimate of ear disease likelihood. CEDRA will consist of questions that focus on recognition of ear disease symptoms. PEDRA will include similar questions, and will also include innovative data analysis tools, developed at the Mayo Clinic, which enhance recognition of otologic disease risk factors in standard audiometric test data. The accuracy of CEDRA and PEDRA based disease screening will be evaluated against the judgments of otologists and neurotologists in a prospective, multisite study involving academic medical facilities across the United States. If CEDRA and PEDRA are found to accurately screen for ear disease, these tools might become useful to safely guide a consumer's decision to use the medical waiver - making hearing aids more affordable and accessible when disease risk is low. If ear disease cannot be detected using these tools under the optimal conditions of this study, the safety of the medical waiver option would have to be challenged.