Closed for Enrollment

• Can Consumers and Audiologists Detect Ear Disease Prior to Hearing Aid use? -Evaluation of CEDRA and PEDRA Jacksonville, Fla.

  The purpose of this study is to determine if lay persons and non-physician hearing healthcare providers (e.g. audiologists) can detect ear disease using focused questionnaires (Consumer Ear Disease Risk Assessment [CEDRA] & audiologist based Ear Disease Risk Assessment tool [PEDRA])? The overarching goal of this work is to decrease the cost and increase accessibility of hearing aids and related hearing healthcare services while protecting consumers from the consequences of unrecognized ear disease. In so doing, we will also decrease the cost burden to the overall healthcare system by encouraging only those consumers with high risk of ear disease to seek medical services rather than the current model that encourages all consumers with age related hearing loss to receive medical clearance prior to hearing aid purchase.

• Can Consumers Detect Ear Disease Prior to Hearing Aid Use? - CEDRA questionnaire Development Jacksonville, Fla.

  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 aid provider (e.g. audiologist or hearing aid specialist). The accuracy by which consumers or non-physician hearing aid providers assess ear disease risk is unknown. We propose to empirically evaluate how well non-physicians (in this stage, Mayo Clinic patients and audiologists) can evaluate their ear disease risk by developing and testing the performance of a consumer focused questionnaire (Consumer Ear Disease Risk Assessment or CEDRA) that is 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. If CEDRA is found to accurately screen for ear disease, it 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 this tool, the safety of the medical waiver option and direct to consumer hearing aid sales (such as over the internet) would have to be challenged.
  
  This work will be accomplished as a sub-contract of a multi-site NIH R21-R33 award. Patients seeking services for hearing related problems in the Otorhinolaryngology (ORL)/Audiology Department at MCF will be asked to complete a prototype questionnaire. Questionnaire responses will be correlated with identified symptoms and neurotologic diagnosis recorded in the EMR. Through an iterative process, involving researchers at Mayo Clinic and Northwestern University, results will be used to create CEDRA for use in the R-33 phase of this work.