Caveat Emptor: Let the buyer beware (just a small Latin lesson to brighten your day :).
Several months ago (Oct. 2021) I wrote about OTC (over-the-counter) hearing aids for mild to moderate sensori-neural hearing loss. At that time, this was a topic being discussed at the Food and Drug Administration (FDA) and nothing had been formally decided; no regulations or guidelines had been written, much less adopted.
We all the know the wheels of government can turn slowly. Add that to the concerns voiced that these products be manufactured properly, advertised correctly, and used properly, and you can see that nothing moves quickly. However, the less scrupulous among us, may jump the gun a bit.
On Dec 10, 2021, the Attorney General for the state of New York issued a consumer alert. Ms. Letitia James warned New Yorkers to be aware of potentially deceptive selling practice for the OTC hearing aids. Be advised: as of now, there are NO OTC hearing aids that have been approved by the FDA.
Medical device companies, hearing aid manufacturers and others, are required to register and list their devices with the FDA. That only means the company has submitted information to the FDA. That does not mean the FDA has approved the device. Be careful when you see phrases like: “FDA-registered” or “FDA-cleared”. These terms imply a higher level of safety review than they have actually received. It is possible that these unregulated hearing devices work as intended, but there is a risk that these hearing devices like personal amplifiers could be defective, inadequate to meet the wearer’s needs, and even harmful.
Here are a few things to consider:
- Beware of misleading claims: OTC hearing aids are meant to treat mild to moderate hearing loss. Avoid purchasing aids that claim to treat severe hearing loss or hearing loss in children.
- Do you research: Be skeptical of testimonials on a seller’s website. Check the better business bureau (BBB) for bad reviews and scams.
- Consider having you hearing checked by a hearing professional like an audiologist: While online tests can be convenient, they may fail to detect serious hearing loss or underlying conditions.
- Know your rights: Most states have a Consumer Protection Department, as well as a Department of Health. At Hears to U and Hears Hearing & Hearables we give everyone that purchases new hearing aids a brochure from the MN Department of Health that discusses your rights; including a 45-day trial period.
The Executive Director of Hearing Loss Association of America. Barbara Kelley, is pleased with these steps. “This is one step closer to seeing OTC hearing devices on the market. Until the FDA issues their final rules, we recommend consumers seek the help of licensed hearing health professionals to address their hearing loss”.
