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

Jasleen Singh; Emma Johnston; Sumitrajit Dhar

doi:10.1055/s-0045-1806804

Seminars in Hearing, Inhaltsverzeichnis

Semin Hear 2025; 46(01): 053-064
DOI: 10.1055/s-0045-1806804

Review Article

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

Autor*innen

Jasleen Singh

¹The Department of Speech, Language, and Hearing Sciences, University of Massachusetts Amherst, Amherst, Massachusetts
Emma Johnston

²The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, Illinois
Sumitrajit Dhar

²The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, Illinois

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.

Keywords

delivery of health care - hearing aids - audiology

Volltext

Referenzen

References
1 Chang J, Lizer A, Patel I, Bhatia D, Tan X, Balkrishnan R. Prescription to over-the-counter switches in the United States. J Res Pharm Pract 2016; 5 (03) 149-154
2 Jacobs LR. Prescription to over-the-counter drug reclassification. Am Fam Physician 1998; 57 (09) 2209-2214
3 Pray W. Forces that shape the nonprescription product market. In: Nonprescription Product Therapeutics. Philadelphia: Lippincott Williams & Wilkins; 2006
4 U.S. Food and Drug Administration. OTC Drug Facts Label. U.S. Food and Drug Administration. Accessed February 9, 2024 at: https://www.fda.gov/drugs/information-consumers-and-patients-drugs/otc-drug-facts-label#:∼:text=In%20the%20Federal%20Register%20of,content%20requirements%20by%20May%202002 . Published 2015
5 Food and Drug Administration. Label Comprehension Studies for Nonprescription Drug Products. Center for Drug Evaluation and Research. 2010
6 Food and Drug Administration. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. 2022
7 Catlin JR, Brass EP. The effectiveness of nonprescription drug labels in the United States: insights from recent research and opportunities for the future. Pharmacy (Basel) 2018; 6 (04) 119
8 King JP, Davis TC, Bailey SC. et al Developing consumer-centered, nonprescription drug labeling a study in acetaminophen. Am J Prev Med 2011; 40 (06) 593-598
9 Yin HS, Mendelsohn AL, Nagin P, van Schaick L, Cerra ME, Dreyer BP. Use of active ingredient information for low socioeconomic status parents' decision-making regarding cough and cold medications: role of health literacy. Acad Pediatr 2013; 13 (03) 229-235
10 United States Census Bureau. Nearly 68 Million People Spoke a Language Other Than English at Home in 2019. United States Census Bureau. Accessed February 9, 2024 at: https://www.census.gov/library/stories/2022/12/languages-we-speak-in-united-states.html . Published 2022
11 United States Census Bureau. Asian Indian Was the Largest Asian Alone Population Group in 2020. United States Census Bureau. Accessed February 9, 2024 at: https://www.census.gov/library/stories/2023/09/2020-census-dhc-a-asian-population.html . Published 2023
12 Budiman A, Ruiz NG. Key facts about Asian origin groups in the U.S. Pew Research Center. Accessed February 9, 2024 at: https://www.pewresearch.org/short-reads/2021/04/29/key-facts-about-asian-origin-groups-in-the-u-s/ . Published 2021
13 Popova L, Nonnemaker J, Taylor N, Bradfield B, Kim A. Warning labels on sugar-sweetened beverages: an eye tracking approach. Am J Health Behav 2019; 43 (02) 406-419
14 Nielsen. Make the Most of Your Brand's 20-Second Window. Nielsen. Accessed February 9, 2024 at: https://www.nielsen.com/insights/2015/make-the-most-of-your-brands-20-second-windown/ . Published 2015
15 Bix L, Bello NM, Auras R, Ranger J, Lapinski MK. Examining the conspicuousness and prominence of two required warnings on OTC pain relievers. Proc Natl Acad Sci U S A 2009; 106 (16) 6550-6555
16 Harris PA, Taylor R, Minor BL. , et al; REDCap Consortium. The REDCap consortium: building an international community of software platform partners. J Biomed Inform 2019; 95: 103208
17 Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42 (02) 377-381
18 R: A Language and Environment for Statistical Computing [computer program]. Vienna, Austria: R Foundation for Statistical Computing; 2021
19 Python Language Reference, [computer program]. Version 3.12.7
20 Catlin JR, Pechmann C, Brass EP. The influence of need for cognition and principal display panel factors on over-the-counter drug facts label comprehension. Health Commun 2012; 27 (03) 264-272
21 American Speech Language Hearing Association. . ASHA OTC Hearing Aid Survey. ASHA2023.
22 Davis TC, Wolf MS, Bass III PF. et al Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med 2006; 21 (08) 847-851