Comprehension and Use of the Over-the-Counter Hearing Aid Product Information Label (2025)

Abstract

The product information label (PIL) is the consumer-focused tool required by the Food and Drug Administration (FDA) to transmit essential health information about candidacy to potential users of over-the-counter (OTC) hearing aids. The OTC hearing aid PIL has not undergone a systematic comprehensibility study, nor have consumers' viewing habits of the OTC PIL been evaluated. The goal of the present study was to use eye-tracking to determine what consumers attend to when looking at an OTC hearing aid package (which includes the PIL), and conduct an assessment of comprehension of the PIL's content in a group of consumers who either spoke English only (EO) or reported English as a second language (ESL). Eye-tracking data showed that the OTC hearing aid PIL did not capture sustained attention from both groups, and most of the PIL content was not comprehended by potential ESL consumers. The OTC hearing aid PIL may not be useful and accessible to consumers in its current form.

Data Availability Statement

Data will be shared upon reasonable request to the corresponding author.

Publication History

Article published online:
21 March 2025

© 2025. Thieme. All rights reserved.

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