Over The Counter (OTC) Hearing Aids Are coming soon; aiming to improve accessibility and affordability. But, will they be safe and effective?

Patients, caregivers and hearing professionals need to know the facts.

FDA regulates OTC Hearing Aids to protect consumers. Because hearing loss is a medical condition, FDA should treat these OTC hearing aids as medical devices, not consumer electronics.

Hearing loss is one of the most common chronic conditions in the US.

Did you know that most adults age 18 or older perceive they have a mild to moderate hearing impairment, but either have a normal hearing (25 dB HL or less) or have a more severe hearing impairment (56 dB HL or higher)?

In 2017 Congress passed an law that mandates FDA to create a new category of hearing aids for mild-to-moderate hearing losses that are available over-the-counter without the supervision of a hearing health professional. This was intended to increase consumer choice and access to devices that treat mild to moderate hearing impairment.

FDA’s Congressional mandate is to draft regulations that ensure these medical devices will be safe and effective, protecting consumers from health risks associated with too much amplification.

The leading scientific voices on hearing care have concluded in a recent consensus paper that the best way to protect consumers is to limit the amplification of these OTC devices by regulating the decibel gain (which enables hearing sounds) and the decibel output (to protect from damage to the ear).

This is where we need your help. To fulfill its Congressional mandate to protect consumer health FDA should regulate these OTC hearing aids based on a medical standard, not a consumer electronics standard.

Your Member of Congress needs to ensure this regulation is done right. Ask them to hold FDA accountable by ensuring that proper safety warnings are in place for consumer.

Access to OTC hearing aids will be good for many consumers, but proper regulation is needed to ensure they don’t cause more harm than good.


Hearing care professionals have agreed on recommendations for sensible OTC hearing device safety and effectiveness. Download their consensus paper that lays out 5 evidence-based and science-supported priorities for FDA consideration.

Academy of Doctors of Audiology
American Speech-Language-Hearing Association
International Hearing Society

Click here to see what Hearing Healthcare professionals think of the new regulations, and to see what you can do to help.

About Hear About Hearing

Hear About Hearing is an informal coalition of hearing care manufacturers, distributors, retailers, industry associations, and provider groups seeking to ensure the FDA rulemaking on OTC amplification devices provides for the reasonable assurance of the safety and effectiveness of OTC devices, and is grounded in sound clinical evidence reflecting the consensus views of the leading experts on the diagnosis and treatment of hearing loss.

Ensure Safety and Effectiveness of OTC Hearing Aids

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