Clinical Trials

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 ...

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 ...