Clinical Trials

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

More information