Singh Jasleen, Johnston Emma, Dhar Sumitrajit
The Department of Speech, Language, and Hearing Sciences, University of Massachusetts Amherst, Amherst, Massachusetts.
The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, Illinois.
Semin Hear. 2025 Mar 21;46(1):53-64. doi: 10.1055/s-0045-1806804. eCollection 2025 Feb.
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.
产品信息标签（PIL）是美国食品药品监督管理局（FDA）要求的以消费者为中心的工具，用于向非处方（OTC）助听器的潜在用户传达有关适用性的基本健康信息。非处方助听器PIL尚未经过系统的可理解性研究，也未对消费者查看非处方PIL的习惯进行评估。本研究的目的是使用眼动追踪来确定消费者在查看非处方助听器包装（包括PIL）时关注的内容，并对一组只说英语（EO）或将英语作为第二语言（ESL）的消费者对PIL内容的理解进行评估。眼动追踪数据显示，非处方助听器PIL没有吸引两组消费者的持续关注，并且潜在的ESL消费者对大部分PIL内容并不理解。非处方助听器PIL目前的形式可能对消费者没有用处且难以理解。
