OTC vs. Prescription hearing aids
When comparing prescription and OTC hearing aids, several differences emerge. Prescription hearing aids are custom-fit and programmed based on the results of a professional hearing test. They are available through an authorized medical provider to individuals of all ages, including children, and typically involve ongoing care from audiologists, including adjustments, follow-up visits, and counseling. Prescription devices are often more expensive, with costs ranging from $1,000 to $6,000 per pair, though some may be covered by insurance or government programs.
In contrast, OTC hearing aids are intended only for adults and are most appropriate for mild to moderate hearing loss. They are typically lower in cost, ranging from $200 to $1,000 per pair, but they do not usually include professional support or follow-up services. Because they are self-fit and sold without an exam, users are responsible for determining if the devices are right for them, although most prescription AND over-the-counter hearing aids come with trial periods or consumer support lines. Insurance generally does not cover OTC hearing aids. Both types of devices are regulated by the FDA, but OTC hearing aids fall under a broader category and are not regulated as medical devices.
Overall, prescription hearing aids remain the best choice for individuals with more complex hearing needs and have a higher success rate due to quality and professional guidance, while OTC hearing aids offer a more affordable and accessible option for those with mild to moderate hearing loss.
What are OTC hearing aids?
Over-the-counter (OTC) hearing aids are hearing devices that are sold directly to consumers without the need for a prescription, medical exam, or fitting by an audiologist. These devices are designed to help adults (18+) with perceived mild to moderate hearing loss. They became available to increase accessibility and affordability, offering consumers more control over their hearing health.
How did OTC hearing aids come into the market?
2017: The U.S. Congress passed the Over-the-Counter Hearing Aid Act of 2017, as part of the FDA Reauthorization Act. This legislation directed the FDA to create a category of OTC hearing aids that are safe and effective for adults with mild to moderate hearing loss. The intent was to foster market competition, reduce cost barriers, and improve accessibility.
October 2021: The FDA issued a proposed rule to establish regulatory guidelines for OTC hearing aids.
August 2022: The FDA finalized the rule, creating a new category of OTC hearing aids.
October 17, 2022: OTC hearing aids officially became available for sale in the U.S.
What should I look for when buying OTC hearing aids?
When shopping for OTC hearing aids, you should ensure that the company is following the FDA regulations.
Intended Use: OTC hearing aids are for adults (18+) with perceived mild to moderate hearing loss.
Performance Standards: Maximum output limit of 111 dB SPL (sound pressure level), or 117 dB SPL if the device has user-adjustable volume control
Labeling Requirements: Clear language that informs consumers the device is not for severe hearing loss or children and guidance on when to consult a hearing health professional
Design Requirements: Self-fitting or user-adjustable settings, No requirement for a licensed provider to be involved