The short answer to this inquiry is that the earliest hearing aid products themselves sold over the counter will be substantively similar to those already available by a licensed professional, though this will likely change in the years to come. With this momentous rule increasing accessibility to the public, many are wondering how new over-the-counter products will differ from those products currently on offer via licensed professionals. However, over-the-counter hearing aids will touch the lives of many and bring the connection to tens of millions of un- and under-served Americans suffering from perceived mild-to-moderate hearing loss, who would otherwise have limited options for relief. For this reason, it is worth reiterating that nothing can replace the high-touch, hands-on service delivery of a skilled licensed professional. Hearing aids broadly serve as an important lens through which audiologists and hearing instrument specialists are able to focus their skill sets. In the modern era, hearing healthcare professionals have worked together with those in need to overcome everything from various pathological and otologic conditions to being able to hear favorite television programs with greater clarity. Since time immemorial, humans have been using some semblance of hearing assistance to help themselves communicate and connect with their environment. To accomplish this goal, it is helpful to consider what the workforce will look like for people capable of servicing products in the market and look broadly at opportunities for technological advancement as it relates to over-the-counter hearing aids. This article will provide clarity on the final OTC rule and the impact that it will have now and in the future. ![]() Now that the FDA’s momentous final rule on over-the-counter (OTC) hearing aids has been finalized, many hearing healthcare professionals have lingering questions about the future of hearing products and services. Remember, if the deal seems too good to be true, it probably is.Tech Topic | February 2022 Hearing Review “Smaller, smarter medical devices are on their way, enabling a reimagining of the status quo.” Consider getting a hearing screen and opinion from a hearing specialist who can tell you whether an over-the-counter hearing device will work for you.Research the seller on the Better Business Bureau website or another objective consumer review site.Over-the-counter hearing aids are not regulated and may simply be PSAP which may be of poor quality and not work for those with hearing loss. ![]() The FDA has not approved any over-the-counter hearing aids.The best way to ensure your hearing aid is legitimate is to seek guidance from a medical professional.īefore purchasing over-the-counter hearing aids, keep the following in mind: According to a bulletin issued by the FDA, these companies often market their products as being "FDA registered" to imply FDA approval, but a registered product is not an FDA-approved product. Sellers of these phony products often entice consumers via websites advertising deals for much less than what a traditional FDA-approved hearing aid would cost. Many of the products sold by these companies are actually Personal Sound Amplification Products (PSAP), not FDA-approved medical devices. ![]() ![]() During Better Hearing and Speech Month, Michigan Attorney General Dana Nessel is issuing this urgent consumer alert to warn consumers to beware of companies selling cheap and phony hearing devices.ĭozens of companies have entered the over-the-counter hearing aid market since the Food and Drug Administration (FDA) relaxed restrictions on the sales of hearing aids in 2017.
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