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

项目摘要/摘要 美国食品和药物管理局(FDA)针对寻求购买听证的成年人的现行政策 艾滋病平衡了两个潜在的相互冲突的医疗保健目标：(1)通过检测邪恶的耳朵来确保公共安全 助听器购买前的疾病，以及(2)使助听器和其他听力保健服务更多 价格实惠且可用。两种疾病监测政策已经演变，反映了这种二分法。美国食品和药物管理局 首选的监测方法要求消费者获得助听器购买前的医疗评估。 这被认为是提供最佳的疾病检测-以降低可负担性和潜在的代价 听力保健服务的可用性。尽管形式上不鼓励，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--潜在的代价是 错过了险恶的耳疾。FDA的两项规定是相互矛盾的，几乎没有经验证据表明 支持将其作为一项有效的公共卫生政策或为替代疾病监测方法提供信息。 当医疗豁免选项被行使时，检测耳朵疾病的负担落在消费者身上 以及提供听力保健服务的非内科医生(如听力专家或助听器专家) 助听器。听力专家能在多大程度上检测出耳部疾病？消费者可以在多大程度上评估他们自己的风险 耳疾？要回答NIDCD提出的更广泛的问题，必须解决这两个关键问题： FDA对助听器采购前的医疗评估和许可的现有要求规定 是对患者的重大保护，还是制造了一个重大的准入障碍？ 我们建议经验性地评估非内科医生(消费者，在这种情况下，还有听力专家) 可以通过开发和测试两个基于问卷的工具的性能来评估耳朵疾病风险- 一个以消费者为重点(消费者耳病风险评估或CEDRA)和一个以供应商为重点 (提供者耳朵疾病风险评估或Pedra)。它们被设计成易于完成，对 耳部疾病风险因素，并产生可转化为耳部疾病统计估计的分数 很有可能。CEDRA将包括专注于耳部疾病症状识别的问题。佩德拉会的 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， 这增强了对标准测听测试数据中耳科疾病危险因素的识别。 Cedra和Pedra疾病筛查的准确性将根据以下判断进行评估 耳科医生和神经病学家参与了一项前瞻性的多地点研究，涉及全国各地的学术医疗机构 美国。如果Cedra和Pedra被发现可以准确地筛查耳部疾病，这些工具可能会 变得有用，以安全地指导消费者决定使用医疗豁免助听器 当疾病风险较低时，可负担得起和可获得。如果无法使用以下工具检测到耳部疾病 在这项研究的最佳条件下，医疗豁免选项的安全性将不得不受到质疑。

PROJECT SUMMARY/ABSTRACT 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 disease. 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 a 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.