The Hearing Industries Association (HIA) announced that it has submitted comments in response to the proposed over-the-counter (OTC) hearing aid rules published by the Food and Drug Administration (FDA) on October 20, 2021. The Over-the-Counter Hearing Aid Act was passed in 2017 as part of the FDA Reauthorization Act (FDARA) and required FDA to create a category for certain over-the-counter hearing aids for adults with perceived mild-to-moderate hearing loss.
In the announcement, HIA states that it “supports the effort to reduce the barriers to access hearing loss treatment, including hearing aids, and appreciates the work of the FDA in crafting these proposed rules.” Overall, an estimated 48 million Americans have some degree of hearing loss, which is linked to significant comorbidities including social isolation, depression, dementia, tinnitus, increased risk of falls, and more.
HIA states that it also “supports the FDA’s position that it is critical to adequately balance accessibility and affordability with safety and effectiveness under the proposed OTC rules.” To that end, HIA believes that “the best way to accomplish these goals is to ensure the continued application of FDA regulatory oversight to hearing aids – OTC or otherwise – and provided several recommendations to the FDA to protect consumers and safely and effectively provide access to hearing loss solutions.”
FDA Should Include Additional Measures to Ensure Safety and Effectiveness of OTC Hearing Aids
The proposed rule relies heavily on labeling to ensure patient safety and product effectiveness but does not cite data showing that the suite of proposed technical and labeling measures will result in the safe and effective use of OTC hearing aids in the intended use population, according to HIA’s announcement. To meet the FDA’s intended objectives, HIA recommends that the FDA take steps to ensure the safety and efficacy of hearing devices before they come to market.
HIA urges FDA to focus on what is best for the consumer by clarifying and strengthening the proposed rule in the following ways:
- Ensuring consumers have all available information to make an informed decision, 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).
It is important to remember that hearing loss is a medical condition and hearing aids – regardless of method of distribution, OTC or prescription – are medical devices, HIA says; it is crucial that the FDA carefully balance access and affordability with safety and effectiveness. HIA will continue to engage with the FDA to support the millions of Americans with hearing loss.
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.