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

描述（由申请人提供）：目前美国食品药品监督管理局（FDA）针对寻求购买助听器的成年人的政策平衡了两个潜在冲突的医疗保健目标：（1）通过在购买助听器之前检测险恶耳疾病来确保公共安全，以及（2）使助听器和其他听力医疗保健服务更实惠和可用。两种疾病监测政策的发展反映了这种二分法。FDA首选的监督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-在降低听力保健服务的可负担性和可用性的潜在成本。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-在错过险恶的耳朵疾病的潜在成本。这两个FDA规定是矛盾的，几乎没有经验证据支持作为一个有效的公共卫生政策或通知替代疾病监测方法。当行使医疗豁免选项时，检测耳部疾病的负担福尔斯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。听力学家如何检测耳部疾病？消费者如何评估自己患耳部疾病的风险？必须解决这两个关键问题才能回答NIDCD提出的更广泛的疑问：“FDA现有的助听器采购前医疗评估和许可要求是否为患者提供了重要保护或造成了重大的使用障碍？“我们建议通过开发和测试两种基于耳道的工具的性能来经验性地评估非医生（消费者，在这种情况下，听力学家）可以评估耳部疾病风险的程度-一种以消费者为中心（消费者耳部疾病风险评估或CEOLS）和一种以提供者为中心（提供者耳部疾病风险评估或佩德拉）。它们被设计为易于完成，对耳部疾病风险因素敏感，并产生可转化为耳部疾病可能性统计估计的评分。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，也将包括创新的数据分析工具，在马约诊所开发，提高识别标准听力测试数据中的耳科疾病风险因素。在一项涉及美国学术医疗机构的前瞻性多中心研究中，将根据耳科医生和神经耳科医生的判断，评估基于CENTRAL和佩德拉的疾病筛查的准确性。如果发现CEOLS和佩德拉可以准确筛查耳部疾病，这些工具可能会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时更实惠和更容易获得。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，则必须质疑医疗豁免选项的安全性。

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.