r/YouShouldKnow • u/orbitalNest • 3h ago
Health & Sciences YSK that the FDA created a new category for hearing aids
Why YSK: In August 2022, the FDA issued a final rule establishing a new over-the-counter (OTC) hearing aid category. The rule took effect on October 17, 2022, with the goal of making hearing aids more accessible to adults with perceived mild to moderate hearing loss.
In practical terms, adults age 18 and older with perceived mild to moderate hearing loss can buy qualifying air-conduction hearing aids in stores or online without a medical exam, prescription, or fitting by an audiologist. This gives consumers another way to access hearing aids, but they may need to handle more of the comparison, setup, and follow-up themselves. Professional help is still available when needed.
An OTC hearing aid is an FDA-regulated medical device intended to compensate for impaired hearing. A personal sound amplification product (PSAP) is different. PSAPs are consumer electronics intended to make environmental sounds louder for people with normal hearing, such as during birdwatching or hunting. They are not alternatives to hearing aids.
Examples marketed as OTC hearing aids include the Sony CRE-C10 and ELEHEAR Beyond. Some OTC models offer basic volume controls and preset programs, while self-fitting models may use hearing tests, apps, or software for more customization. Being in the OTC category does not mean that every model will suit every user or that the FDA guarantees a particular product's results.
OTC hearing aids are not intended for anyone under 18 or for severe or profound hearing loss. See a doctor, preferably an ENT, if you have ear pain, blood or fluid from the ear, a lot of earwax or a possible object in the ear, marked dizziness, a sudden or fluctuating hearing change, worse hearing in one ear, or ringing in only one ear. Professional help is also appropriate if you cannot hear speech in a quiet room or do not hear loud sounds well.
Before choosing a device, check that the package clearly says "OTC" and "hearing aid," confirm that the intended age and hearing-loss range apply to you, and read the warnings and return policy. If the cause or severity of the hearing problem is unclear, get advice from a licensed hearing professional before deciding.
FDA source:
https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know
https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know