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.
This work will determine how well audiologists and consumers can detect ear disease prior to hearing aid purchase using newly developed questionnaire-based screening tools. If these tools are effective, hearing aids should become safer, more affordable, and easier to obtain because consumers would know their risk for ear disease and use this information to decide whether to obtain or waive the FDA standard pre-purchase medical evaluation. If the tools are not effective, we will have strong evidence that allowing a waiver of the pre- purchase medical evaluation carries risks from a public health point of view.