The U.S. Food and Drug Administration (FDA) established a regulatory category for over-the-counter (OTC) hearing aids in 2022, distinguishing them from prescription hearing devices. The 2022 ruling set forth new compliance standards for hearing aid manufacturers to protect users from false advertising and make hearing care more accessible. Hearing aid brands were required to comply with those changes by April 2023.
What are Over-The-Counter Hearing Aids?
OTC hearing devices are air-conduction hearing aids that amplify sound and send it through your ear canal to your eardrum. You don’t need a prescription to purchase an OTC hearing aid and can buy them online or in stores.
You do not have to complete a hearing test or seek professional intervention to purchase these hearing aids. OTC devices were created to improve accessibility to affordable hearing devices for those who couldn’t afford prescription alternatives.
OTC Hearing Aid Regulations from the FDA
The FDA classified OTC hearing aids as medical devices used to treat hearing loss, differentiating them from hearables, sound amplifiers and personal sound amplification products.
OTC hearing device regulations include:
- Scope: These devices are intended for adults 18 and older with perceived mild to moderate hearing loss. OTC hearing aid selection is based on self-diagnosis of your degree of hearing loss.
- Labeling: OTC devices must have visible, easy-to-read directions on usage, along with descriptions of mild to moderate hearing loss. The packaging should provide information on when to seek professional assistance if the devices are inadequate.
- Performance: Per FDA regulations, OTC hearing aids can’t amplify sounds more than 111 decibels for user safety.
- Design: The innermost component of an OTC device must be at least 10 millimeters away from your eardrum to protect against physical and acoustic injury.
What Do OTC Hearing Aid Regulations Mean for Me?
As OTC devices continue to develop, there will likely be more changes to their design and scope in years to come. Understanding FDA requirements can help you make informed decisions when comparing OTC and prescription hearing aids. You’ll have more awareness of what features to look for to address your unique needs and how to identify non-compliant products.
H2: Hearing Aid Services in Northern Iowa and Southern Minnesota
Hearing Associates is committed to helping you achieve your hearing wellness goals through personalized services and innovative technology. We offer a variety of hearing aid styles from most major manufacturers. You can also bring your OTC devices into one of our offices, and our expert team will assess them to determine if they’re suitable for your needs. Ready to get started? Call 888-760-2032 or schedule your appointment online today.