The New York Attorney General is warning consumers to watch out for unregulated and potentially harmful over-the-counter hearing aids. Advertisements for these new OTC hearing aids have already targeted New York consumers, even though currently none of them has received FDA approval.
Medical device companies are required to register and list their devices to the FDA, but it doesn’t indicate that they get the FDA approval. However, some disreputable sellers of OTC hearing devices still falsely claim as “FDA-registered” or “FDA-cleared”.
Attorney General Letitia James emphasized the risk of these unsafe devices to consumers.
“Hearing loss impacts individuals of all ages and backgrounds and I urge all New Yorkers to do their research before shopping for these devices,” said Attorney General James. “...While consumers may be tempted to purchase these unregulated and unlawful products because of their low prices, the ultimate price you pay may be further hearing loss.”
New York law only allows licensed audiologists to sell hearing aids. However, a rule proposed last month by the U.S. Food and Drug Administration permits a new category of OTC hearing aids. Unregulated hearing aids may work as intended, but they could also be completely inadequate for the treatment of hearing loss or cause further harm.
The Attorney General’s office suggests those considering buying one of these hearing aids first do their research and be away of misleading claims.