Over-The-Counter Hearing Aids: What Do Consumers Need To Know?

A New Service Delivery Model for Hearables

“…Hearing aids, hearables, personal sound amplification devices (PSAPs), and sound amplifiers are all designed to help people hear better, but with differences in terms of features and regulatory requirements 1 (Figure 1 2).…”

“…Opinions within the audiology community varied about the potential impact of these newer products and the OTC and DTC sales models, ranging from “doom and gloom” to recognition of a significant opportunity. 5 Concerns have been raised, including that: hearables may pose a danger to patients who might purchase devices inappropriate for their hearing needs 1,2 patients might have negative experiences, which could further delay seeking help for hearing aids 1 hearable sales might cannibalize hearing aid sales and place financial pressures on clinics 5 audiologists might become obsolete as consumers purchase direct from manufacturers. 6 However, those in support of these products voice potential benefits, including: increased accessibility due to convenience 1 availability of low-cost products opening accessibility and addressing affordability for low-income earners 7 availability of products specifically designed for minimal hearing difficulties, thus opening the market to those who previously were not eligible or had rejected hearing aids 8,9 the potential for hearables to function as a gateway product, encouraging people to adopt hearing intervention earlier.…”

“…hearables may pose a danger to patients who might purchase devices inappropriate for their hearing needs 1,2…”

“…There are a number of articles to help audiologists understand the strengths and limitations of hearables, with a particular emphasis on OTC and DTC models. 2,6,8 However, there has been less attention on how one might incorporate hearable products into an established audiology service delivery model. 3 Our preliminary research (Bothe et al, in prep) suggests that clinicians feel some reservation toward and uncertainty about hearables and their place in audiology practice, despite viewing them as a useful tool.…”

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss

“…This has been possible due to the convergence of traditional hearing aids, which are medical devices, with consumer audio devices, creating a whole array of hybrid devices such as Personal Sound Amplification Products (PSAPs) and hearables. Currently, there are several hearing devices on the market, of which some are medical devices intended for individuals with hearing loss and regulated by the FDA (i.e., prescription hearing aids, self-fitting OTC hearing aids, pre-set OTC hearing aids), and other devices that serve as hearing enhancement devices for individuals with normal hearing who have an average hearing thresholds of 25 dB or better in frequencies 500 Hz, 1,000 Hz, 2000 and 4,000 Hz (i.e., PSAPs, hearables) or those used mainly for entertainment purpose (i.e., consumer audio devices) ( Manchaiah et al, 2023 ) ( Figure 1 ). Some manufacturers are blurring the lines between these categories and offering sound enhancement and personalization of acoustic output for persons with hearing loss using smartphone-based earphones with an accompanying smartphone app ( Lin et al, 2022 ).…”