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OTC Hearing Devices – Legislation

In 2017, legislation was passed to authorize the FDA to create a new classification of entry-level hearing devices. While final recommendations were due summer of 2020, the pandemic has delayed the authorization indefinitely. These hearing devices would be designed for individuals with “perceived mild to moderate hearing loss” and would be purchased over the counter.  This legislation is in line with recommendations from both President’s Council of Advisers on Science and Technology and the National Academies of Science Engineering and Medicine recommendations. The Over The Counter Hearing Aid Act (H.R. 1652) plans to make starter hearing aids more accessible to Americans with hearing loss. Safety regulation and standards have not yet been determined by the FDA. Word of Caution: lack of final authorization has not prevented manufacturers from selling devices labeled as “FDA-registered” or “FDA-cleared” in an effort to circumvent government oversight.

What is an OTC hearing device?

An OTC hearing device is a hearing amplifier (and eventually an FDA regulated hearing aid) designed to provide amplified sound for individuals with mild to moderate hearing loss. On the outside, an OTC may look very similar to a standard hearing aid. OTCs are usually not programmable and are one-size-fits-all in style and features. OTC hearing devices are intended to be worn like dime-store reading glasses. It should be assumed that one’s level of hearing impairment is minimal and that the OTC device will only be used in select environments. If you find you are desiring hearing support in many listening environments, you should be evaluated for a traditional hearing aid.

Will an OTC hearing device help me?

The first step when pursuing hearing care is ALWAYS a comprehensive hearing evaluation by a licensed audiologist.  At the UNC Hearing & Communication Center, our board certified audiologists can help diagnose your exact degree and type of hearing loss. Most health insurance plans cover this testing.  We also already offer an array of affordable hearing solutions for every budget. We even prescribe available OTC amplifiers when appropriate. While OTC hearing devices may seem appealing at first, most individuals with hearing loss require the professional services and expertise of an audiologist to make sure they get the most out of their investment. Don’t let cost deter your from hearing better and being connected to friends and loved ones. Make an appointment today to learn more and begin your hearing journey!

Ask yourself: Do I want to be a patient or a consumer? The answer may direct you to the level of services required to treat your hearing need.

What if I already own OTC hearing devices?

Already own devices from another provider or from the store/online? We’d be happy to help! Often devices can be optimized and improved using our best practice fitting and programming methods. Our unbundled billing model make us the perfect provider to assess your devices, only charging you for the services you need. Make an appointment with one our audiologists to see if your current devices are providing you your best hearing. (visit Improve My Current Aids for more information) It is also important to remember that hearing treatment should be more than the device. Aural rehabilitation and counseling can further improve your ability to communicate.