Getting It Right for the Consumer

by Kate Carr, HIA President

January 18, 2022


Hearing health is essential and an important part of a healthy and active lifestyle. Untreated hearing loss is associated with a host of health and related issues, including social isolation, depression, falls, and research showing links to cognitive impairments. However, only about one in three persons take the steps to address their hearing loss through use of hearing aids.


The Hearing Industries Association (HIA), a forum for hearing aid manufacturers, suppliers, and providers, strongly supports increased access to hearing health solutions and affordability of hearing aids. Through research, technological advancements, and a deep understanding of the importance of hearing health and the role of the hearing health professional, HIA members strive to provide the best hearing loss solutions to fit the unique hearing loss and lifestyle of each individual.


This year, the U.S. Food and Drug Administration (FDA) is expected to finalize regulations creating a new category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. This is a major change and an exciting time for the approximately 38 million U.S. adults with hearing loss, creating an additional pathway to addressing hearing loss and the potential to improve overall health and wellbeing.


It is important to remember that hearing loss is a medical condition and hearing aids – whether OTC or prescription – remain medical devices. It is crucial that the FDA, while increasing access for more adults with hearing loss, also ensure the safety and effectiveness of the devices that will eventually enter the OTC market and become more widely available to consumers. This is the core of the FDA’s mission, safety and effectiveness, balanced with increased access and affordability.


As the public comment period comes to a close and the FDA begins to review and refine the proposed regulations, HIA encourages the FDA to focus on what is best for the consumer by:


  • Ensuring consumers have all available information to make an informed decisions, understand use and safety instructions, and potential risks through comprehensive labeling.
  • Protecting consumers by adopting federal consumer protections, such as return periods, receipt requirements, and warranties.
  • Setting safe amplification levels for mild to moderate hearing loss to prevent potential damage caused by loud sounds by limiting output to 110 dB and gain to 25 dB.
  • Providing clarity through precise definitions of terms, particularly with respect to self-fitting hearing aids.
  • Assuring safety and efficacy by requiring the FDA review of all OTC hearing aids before they enter the market (510(k) process).


We all share the common goal of providing accessible and affordable solutions for those with hearing loss. HIA urges the FDA to keep its focus on the consumer through strong, safe, and effective regulation of the forthcoming OTC hearing aid market.


At the end of the day, this is about getting it right for the millions of Americans with hearing loss. If we don’t get it right, we risk losing the opportunity to advance hearing health and address the significant health challenges facing those with hearing loss. We simply can’t let this chance pass us by.

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