Aug 22, 2022

The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public access to these devices.

FDA’s final rule sets general controls for OTC hearing aids in order to “improve access to and foster innovation in hearing aid technology for Americans, thereby promoting the public health,” according to the agency, noting that roughly 30 million US citizens are affected by hearing loss. Allowing OTC sales of these devices will remove barriers to access such as high cost and value in terms perceived benefit of use versus price.

The long-awaited final rule replaces FDA’s 2021 proposed rule on OTC hearing aids, and follows legislation passed by the US Congress in 2017 mandating the creation of the OTC hearing aid category.

Which hearing aid devices qualify for the new OTC category?

FDA states that hearing aids to be made available over the counter are intended to target perceived mild to moderate hearing loss for people aged 18 and older. The final rule provides performance and design requirements for the new OTC hearing aid category, including:

  • Output limits in terms of decibels of sound pressure (111 dB SPL, in general)
  • Design requirements in terms of allowable insertion depth and user-adjustable volume controls
  • Labeling that is understandable for non-expert hearing aid users
  • Conditions for sale, which do not include age verification requirements for OTC hearing aids
  • Quality system requirements, which entail full 21 CFR Part 820 compliance for  medical devices

In addition, FDA plans to require 510(k) clearance for devices commercialized through the new OTC hearing aid category.

Distinguishing between hearing aids and personal sound amplification products

To complement the final rule on OTC hearing aids, FDA has also published guidance to distinguish between hearing aids, regulated as medical devices, and personal sound amplification products (PSAPs), regulated as consumer products.  

The guidance notes that in general, hearing aids are intended for use to compensate for hearing impairment or loss, whereas PSAPs are used to amplify external sounds for recreational purposes. Now that some hearing aids are more easily accessible over the counter, the guidance provides more clarity in terms of regulatory distinctions between hearing aids and PSAPs for manufacturers, retailers and users.

Both the final rule on OTC hearing aids as well as the guidance on hearing aids versus PSAPs take effect October 17, 2022.

Additional US FDA medical device regulatory resources from Emergo by UL:

  • FDA 510(k) consulting for medical device and IVD manufacturers
  • US FDA medical device classification support
  • FDA Pre-Sub (Q-Sub) consulting for medical device companies

Author

  • Stewart Eisenhart

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