Klyn, Niall A. M.

This article introduces the Consumer Ear Disease Risk Assessment (CEDRA) tool. CEDRA is a brief questionnaire designed to screen for targeted ear diseases. It offers an opportunity for consumers to self-screen for disease before seeking a hearing device and may be used by clinicians to help their patients decide the appropriate path to follow in hearing healthcare. Here we provide highlights of previously published validation in the context of a more thorough description of CEDRA’s development and implementation. CEDRA’s sensitivity and specificity, using a cut-off score of 4 or higher, was 90% and 72%, respectively, relative to neurotologist diagnoses in the initial training sample used to create the scoring algorithm (n = 246). On a smaller independent test sample (n = 61), CEDRA’s sensitivity and specificity were 76% and 80%, respectively. CEDRA has readability levels similar to many other patient-oriented questionnaires in hearing healthcare, and informal reports from pilot CEDRA-providers indicate that the majority of patients can complete it in less than 10 min. As the hearing healthcare landscape changes and provider intercession is no longer mandated, CEDRA provides a measure of safety without creating a barrier to access.

Objectives: The purpose of this study was to evaluate the specificity and sensitivity of two red flag protocols in detecting ear diseases associated with changes in hearing. Design: The presence of red-flag symptoms was determined in a chart review of 307 adult patients from the Mayo Clinic Florida Departments of Otorhinolaryngology and Audiology. Participants formed a convenience sample recruited for a separate study. Neurotologist diagnosis was the criterion for comparisons. Results: Of the 251 patient files retained for analysis, 191 had one or more targeted diseases and 60 had age- or noise-related hearing loss. Food and Drug Administration red flags sensitivity was 91% (confidence interval [CI], 86 to 95%) and specificity was 72% (CI, 59 to 83%). American Academy of Otolaryngology-Head and Neck Surgery red flags sensitivity was 98% (CI, 95 to 99%) and specificity was 20% (CI, 11 to 32%). Conclusions: Stakeholders must determine which diseases are meaningful contraindications for hearing aid use and whether these red-flag protocols have acceptable levels of sensitivity and specificity. As direct-to-consumer models of hearing devices increase, a disease detection method that does not require provider intercession would be useful.