Your Cart

New FDA Proposal to Categorize OTC Hearing Aids and Improve Accessibility

New FDA Proposal to Categorize OTC Hearing Aids and Improve Accessibility

Oct 25, 2021

Horace Kim

Acquiring hearing aids was previously a fairly difficult and lengthy process with requirements that could deter many who needed hearing aids from getting them - particularly those with mild-to-moderate levels of hearing loss. Thanks to the passing of the preliminary Food and Drug Administration Reauthorization Act (FDARA) of 2017, people have been free to purchase hearing aids without the restrictions of obtaining a prescription, medical exam, and meeting with an audiologist for a fitting.

Last Tuesday, October 19th, the FDA released a proposal for new rules to officially categorize over-the-counter (OTC) hearing aids. This new proposal has actually been in the works for quite some time - its postponement was another casualty of the recent COVID-19 pandemic. The FDA document, titled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” covers specific labeling/packaging requirements and electroacoustic device regulations for OTC hearing aids in efforts to make it easier and safer for consumers to purchase these devices, as well as foster an environment for more market competition by also making it easier for new hearing aid manufacturers to enter the fold. This effort follows President Joe Biden’s Executive Order on Promoting Competition in the American Economy that was signed in early July of this past year.

The new rules are groundbreaking for the entire hearing aid industry and hard of hearing community; the FDA is also proposing changes to the classification of professionally fit or “prescription” hearing aids by getting rid of the medical evaluation requirement for these devices. With this proposal the FDA is acknowledging the need for change in the outdated restrictions and regulations of hearing aids while also ushering in a new era for the purchase of OTC hearing aids and professionally dispensed hearing aids.

People with hearing loss looking to buy hearing aids at an affordable price and convenient method can expect to see a lot more viable options popping up for them in the near future. Ceretone’s mission has always been to provide fair-cost premium hearing aid devices for those that need them in the simplest and most convenient way with our online store. Follow our weekly blog posts to stay updated on all the latest hearing news!