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

项目总结/摘要 美国食品和药物管理局（FDA）针对寻求购买听力的成年人的现行政策 艾滋病平衡了两个潜在冲突的卫生保健目标：（1）通过检测险恶的耳朵来确保公共安全 （2）使助听器和其他听力保健服务更加有效， 负担得起和可用。两种疾病监测政策的发展反映了这种二分法。FDA的 优选的监视方法要求消费者获得助听器购买前的医学评估。 这被认为是提供最佳的疾病检测-在降低负担能力的潜在成本， 提供听力保健服务。虽然正式劝阻，消费者可以放弃医疗 评估，从而可能增加听力保健服务的可及性-潜在的成本 失踪的邪恶耳疾病FDA的两项规定相互矛盾，几乎没有经验证据表明 作为一项有效的公共卫生政策，或为替代性疾病监测方法提供信息。 当行使医疗豁免选择权时，检测耳部疾病的负担就落在消费者身上了，福尔斯 以及提供听力保健服务的非医生听力保健提供者（例如听力学家或助听器专家）， 助听器.听力学家如何检测耳部疾病？消费者如何评估自己的风险 耳疾？必须解决这两个关键问题，以回答NIDCD提出的更广泛的问题： 现有的FDA要求在购买助听器之前进行医疗评估和许可， 对患者有显著的保护作用，还是造成了显著的访问障碍？" 我们建议经验性地评估非医生（消费者，在这种情况下，听力学家） 可以评估耳部疾病的风险，通过开发和测试两种基于耳的工具的性能- 一个以消费者为中心（消费者耳病风险评估或CEOLS），一个以提供者为中心 （提供者耳部疾病风险评估或佩德拉）。它们被设计成易于完成，对 耳部疾病风险因素，并产生一个评分，可以转化为耳部疾病的统计估计 可能性听力测试将包括重点关注耳部疾病症状识别的问题。佩德拉将 包括类似的问题，还将包括创新的数据分析工具，在马约诊所开发， 这增强了对标准听力测试数据中耳科疾病危险因素的识别。 将根据以下判断评价基于CENTRAL和佩德拉的疾病筛查的准确性： 耳科医生和神经耳科医生在一项前瞻性的多地点研究中， 美国的如果发现CERNET和佩德拉可以准确地筛查耳部疾病，这些工具可能 成为有用的安全指导消费者的决定使用医疗豁免-使助听器更多 在疾病风险较低的情况下，如果使用这些工具无法检测到耳部疾病， 在本研究的最佳条件下，医疗豁免选择的安全性将受到质疑。

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.