Conway, K., Knoetze, M., Swanepoel, D.W., Nassiri, A., Sharma, A., & Manchaiah, V.
Otology & Neurotology, 47(2), e145-150. https://doi.org/10.1097/MAO.0000000000004767
Publication year: 2026

Introduction: Over-the-counter (OTC) hearing aids have become increasingly accessible, yet limited information exists regarding their online listings and marketing practices. This study evaluated cost, satisfaction ratings, review, volume, readability of product descriptions, and Food and Drug Administration (FDA) clearance status of OTC hearing aid listings on Amazon.com.

Materials and Methods: This cross-sectional, descriptive study analyzed 138 Amazon OTC hearing aid listings. Listing characteristics were extracted, and FDA clearance was verified. Analyses included descriptive data on listing characteristics and nonparametric analysis of key variables: price, FDA-clearance status, device type, and form factor. Readability indices were used to assess the accessibility of product descriptions.

Results: Of the 138 listings analyzed, 92 listings (66.7%) identified their product as “OTC hearing aids”, while only 37 (26.8%) were verified as FDA-cleared. FDA-cleared devices cost significantly more than non-FDA cleared devices. Behind-the-ear (BTE) devices had a significantly higher number of reviews compared to in-the-ear (ITE) devices. The readability of product descriptions was advanced, ranging from 11th-grade to college graduate levels. Additionally, 52 listings (37.7%) lacked specific marketing for mild-to-moderate hearing loss, and 13 (9.4%) were marketed to those with hearing loss beyond mild-to-moderate.

Discussion: Amazon listings for OTC hearing aids reveal significant inconsistencies in marketing and labeling, including misleading FDA clearance claims and inadequate accessibility of product information. Advanced readability levels and marketing for hearing loss degrees beyond mild-to-moderate further impede consumers’ ability to make informed purchasing decisions. These findings highlight the urgent need for stricter regulatory oversight and improved dissemination of accurate, accessible consumer information.