Over-the-Counter Hearing Aids

By Kathy Mellott, AuD

The Over-the-Counter (OTC) Hearing Aid Act of 2017 is reported as consumer-focused: “This bill will improve consumer access to hearing aids by making them available over-the-counter for the first time.”

This message is misleading.

The OTC bill uses the power of government to re-brand existing devices that are already sold over-the-counter. There is no improved access; the devices covered by this bill are already available over-the-counter. The bill will simply empower the FDA to regulate them as medical devices, allowing some companies to use government regulation to their financial advantage.

The devices in question are known as personal sound amplification products (PSAPs). They simply amplify sound. Hearing aids are complex and highly tailored to a patient’s need due to the complexity of hearing loss – its causes, its severity and type.

PSAPs are fine for their intended purpose. But if an individual has a significant hearing loss, PSAPs probably aren’t going to solve their problem. Rep. David McKinley (R-WV) shared his story of how he damaged his own hearing by self-treating with an amplification device instead of consulting with a professional.

The best option for patients and consumers is to consult a doctor of audiology for a diagnosis of their unique hearing loss situation. There’s nothing wrong with allowing PSAPs to be sold over-the-counter, as long as it is clear that they are different from traditional hearing aids. Buying a PSAP on your own, inserting it into your ear and turning up the volume is an overly simplistic way to treat hearing loss, and could be dangerous.

The OTC Hearing Aid Act will not improve patient access to new technology. It will insulate a favored industry by using the power of government to create a new marketing category.