Frequently Asked Questions About OTC Hearing Aids
Over-the-counter or OTC hearing aids are hearing aids that can be purchased online or in stores and do not require a medical exam, prescription or fitting adjustment by an audiologist.
OTC hearing aids are intended for the tens of millions of Americans over 18 years of age with perceived mild to moderate hearing loss.
As the FDA explains in the final rule that created OTC hearing aids: the individual’s perception of hearing loss would be akin to many other situations where an individual perceives a medical condition and purchases an OTC medical product. Take a headache for instance. If you perceive a headache, you can purchase an OTC product for relief or if you experience certain symptoms, you should seek the help of a medical professional. In many ways, the responsibility is placed on the individual. In lieu of an audiogram (hearing test), the onus is placed on the user or prospective user to notice their own hearing loss when doing something like listening to music.
If you’re over the age of 18 and live in the U.S., you certainly can. However, if you are experiencing any of the following, please consult a licensed physician: Fluid (namely blood or pus) coming from your ear. Discomfort or pain in your ear. History of excessive ear wax Vertigo (episodes of severe dizziness) along with loss of hearing Hearing loss that has noticeably changed (bad to good, more to less) in the previous 6 months. Tinnitus (ringing in the ear) or hearing loss in only one ear.
Hearing aids for Americans with severe and/or profound hearing loss as well as for those under the age of 18 remain a prescription medical device.
A PSAP is a personal sound amplification product. These products are intended to augment the hearing of a person without hearing loss in certain environments like birdwatching or hunting.
Hearing aids are medical devices that are intended to alleviate the effects of hearing loss. PSAP or personal sound amplification products are intended to be used by people without hearing loss in order to augment their hearing and hear sounds that a normal person would not.
If you receive your hearing aids and decide that - for any reason - you no longer want/like/need them, you may return them within 30 days for a refund. There are a few (totally normal kind of stuff) stipulations that you are welcome to read about in the Returns and Refunds section (5) of our Terms of Sale.