What are OTC hearing aids?
Over-the-counter (OTC) hearing aids are a new category of hearing aids for adults with perceived mild to moderate hearing loss. Like regular hearing aids, OTC hearing aids make sounds louder so that some adults with difficulty hearing are better able to listen, communicate, and participate fully in daily activities.
Who are they for?
OTC hearing aids will be specifically for adults with perceived mild to moderate hearing loss. They are not meant for children or for adults who have more severe hearing loss or significant difficulty hearing. They will be available for purchase online and in stores and not require a prescription or office visit.
Limitations
There are many requirements and limitations regarding OTC hearing aids, including the maximum sound output, how deep the aid can be inserted in the ear canal, the need for user-adjustable volume control, and the inclusion of clear, simple instructions for use.
OTC hearing aids will help:
-
Mild to moderate hearing loss.
-
If you don’t want a prescription or to visit an office.
OTC hearing aids will not help:
-
If you have trouble hearing conversations in quiet environments.
-
If you have trouble hearing loud sounds like power tools or motor vehicles.
EXPECTED COST
According to industry experts, good OTC hearing aids are expected to cost between $300 and $500 each ($600 to $1,000 per pair) compared to several thousands of dollars for those that need prescriptions and multiple trips to a hearing specialist.
For 26 years, Advanced Affordable Hearing has been cutting out unnecessary visits and steps while providing high-quality and technologically advanced FDA-registered hearing aids online and over the phone at prices similar to and sometimes lower than OTC hearing aids. Shop our high quality, affordable devices here.
Please note: OTC manufacturers will not be required to take back the devices if they do not help and will likely not provide customer service, support, or technical assistance. Advanced Affordable Hearing, on the other hand, takes pride in providing top-notch customer support and service for as long as you use our hearing aids.
OTC vs. REGULAR HEARING AIDS
The American Speech-Language-Hearing Association, or ASHA, put together the below graphic to help illustrate to consumers the unique differences between OTC and regular hearing aids.
OTC HISTORY
In 2017, Congress passed legislation requiring the FDA to permit the sale of OTC hearing aids without a prescription.
In October 2021, the FDA reviewed thousands of public comments from patients, public health organizations, and advocacy groups on the proposed rule.
The final rule, which was published on August 16, 2022, is effective as of mid-October 2022. Over-the-counter hearing aids are likely available at local drugstores and other retailers.
OTC in the MEDIA
What to know before buying over-the-counter hearing aids
The Food and Drug Administration moved this week to make hearing aids available without a prescription or medical exam, opening new opportunities for the vast majority of the 40 million Americans...
Are OTC hearing aids available yet? What to know about when (and where) you can get them.
The Food and Drug Administration moved this week to make hearing aids available without a prescription or medical exam, opening new opportunities for the vast majority of the 40 million Americans...
F.D.A. Clears Path for Hearing Aids to Be Sold Over the Counter
The agency’s action opens the door to cheaper, more accessible devices without a prescription or medical exam.
Tips
Over-the-Counter (OTC) Hearing Aids
Over-the-Counter (OTC) hearing aids will soon be available directly to consumers. They are intended for adults with mild to moderate hearing loss. HLAA’s OTC Tip Sheet Can Help