HIA Responds to Proposed FDA OTC Hearing Aid Rule


Washington, DC, Jan. 18, 2022 (GLOBE NEWSWIRE) — The Hearing Industries Association (HIA) has submitted comments in response to proposed over-the-counter (OTC) hearing aid rules issued by the Food and Drug Administration (FDA) on October 20, 2021. The Over-the-Counter Hearing Aids Act was passed in 2017 as part of the FDA Reauthorization Act (FDARA) and required the FDA to create a category for certain over-the-counter hearing aids for adults with mild to moderate hearing loss.

HIA supports efforts to reduce barriers to access to hearing loss treatment, including hearing aids, and appreciates the work of the FDA in developing 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, etc.

HIA supports the FDA’s position that it is critical to properly balance accessibility and affordability with safety and efficacy under the proposed OTC rules. To that end, HIA believes that the best way to achieve these goals is to ensure the continued application of FDA regulatory oversight to hearing aids – OTC or otherwise – and has provided several recommendations to the FDA to protect consumers. and providing safe and effective access to hearing. loss solution.

FDA should include additional measures to ensure the safety and effectiveness of over-the-counter hearing aids

The proposed rule relies heavily on labeling to ensure patient safety and product efficacy, but does not cite data showing that the proposed suite of technical and labeling measures will result in the safe and effective use of over-the-counter hearing aids in the population of intended use. To achieve the FDA’s intended goals, HIA recommends that the FDA take steps to ensure the safety and effectiveness of hearing aids before they are placed on the market.

HIA urges the FDA to focus on what is best for the consumer by clarifying and strengthening the proposed rule as follows:

  • Ensure consumers have all the information available to make an informed decision, understand usage and safety instructions, and potential risks through comprehensive labeling.
  • Protect consumers by enacting federal consumer protections, such as return deadlines, receipt requirements and warranties.
  • Set safe amplification levels for mild to moderate hearing loss to avoid potential damage from loud sounds by limiting output to 110dB and gain to 25dB.
  • Bringing clarity through precise definitions of terms, especially when it comes to self-adjusting hearing aids.
  • Ensure safety and effectiveness by requiring FDA review of all over-the-counter hearing aids before they are placed on the market (510(k) process).

It is important to remember that hearing loss is a medical condition and hearing aids – regardless of the method of distribution, over-the-counter or prescription – are medical devices. It is crucial that the FDA carefully balance access and affordability with safety and efficacy. HIA will continue to engage with the FDA to support the millions of Americans suffering from 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 for s adapt to each individual’s unique hearing loss and lifestyle.


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