Attorney General James Issues Alert to Warn New York Consumers to Be Cautious of Companies Marketing

December 10, 2021


Consumers Who Believe They Have Been Misled or Scammed by Sellers of Over-the-Counter Hearing Aids Should File Complaint With OAG


NEW YORK — New York Attorney General Letitia James today issued a consumer alert warning New Yorkers about deceptive companies selling unregulated and potentially faulty over-the-counter (OTC) hearing aids. New York law requires that hearing aids only be sold by licensed audiologists or hearing aid dispensers after such a provider has performed an exam and fitting. Last month, the U.S. Food and Drug Administration (FDA) proposed a rule permitting the sale of a new category of OTC hearing aids that could be sold directly to consumers without an exam. While unregulated OTC hearing aids may work as intended, there is a risk that the devices could be defective or completely inadequate for the treatment of hearing loss. Advertisements for these new OTC hearing aids have already targeted New York consumers even though there are currently no OTC hearing aids that have received FDA approval.


“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. “Companies that sell over-the-counter hearing devices are not held to the same standards as the licensed professionals who provide these critical devices, and they are not required to inform consumers of the risks associated with their products. 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.”


Medical device companies are required to register and list their devices with the FDA, though this registration only indicates that the company has provided information to the FDA; it does not indicate FDA approval, clearance, or authorization of the device. Unfortunately, this has not stopped some disreputable sellers of OTC hearing devices from falsely claiming that their products are “FDA-registered” or “FDA-cleared.”


If you are considering buying a hearing aid, the Office of the Attorney General recommends the following tips:

  • Beware of misleading claims. Over-the-counter hearing aids are only meant to treat mild to moderate hearing loss and may not be able to treat severe hearing loss. Avoid purchasing OTC hearing aids that claim to treat severe hearing loss or hearing loss in children.

  • Do your research. Be skeptical of testimonials on a seller’s website. Instead, check with the Better Business Bureau to see if they have a good rating and whether consumers have submitted complaints against the company before you purchase a product.

  • Consider having your hearing evaluated by a medical professional. While online hearing tests may be convenient, they may fail to detect serious hearing loss, or the underlying causes of your hearing loss.

  • Know your rights: Under New York law (General Business Law § 798(11)), if you are unhappy with your hearing aids you are allowed to return them within 45 days of receipt, including batteries, cords, and accessories and all fees related to the hearing aid, for a full refund less 10 percent. The seller must provide you with a written statement with this information. If a seller offers a longer return period, they must honor it.

“HLAA is pleased to see the proposed rules on over-the-counter hearing aids released by the FDA. This is one step closer to seeing OTC hearing devices on the market for adults with mild to moderate hearing loss,” said Barbara Kelley, executive director, Hearing Loss Association of America (HLAA). “We are also pleased to see the Office of the Attorney General is educating consumers about OTC hearing aids. Until the FDA issues their final rules, we recommend consumers seek the help of licensed hearing health professionals to address their hearing loss.”


“As the FDA finalizes its rules for the sale of OTC hearing aids, consumers should continue to watch out for misleading marketing practices from companies jumping the gun to enter New York’s market,” said Chuck Bell, programs director, Consumer Reports. “We agree that the terms ‘FDA-registered’ or ‘FDA-cleared’ for OTC hearing aids are inappropriate, and imply a higher level of safety review than these products actually receive. Consumers who think they may need a hearing aid should seek a medical evaluation to determine whether the hearing loss they have is serious in nature and/or potentially reversible.”


“As an organization dedicated to protecting New York City’s aging and disabled population for almost 50 years, RiseBoro is committed to providing vital care,” said Scott Short, CEO, RiseBoro, Community Partnership. “We commend Attorney General Letitia James and her office for doing their part to protect seniors from these bad actors.”


“Scams targeting the older population happen too frequently,” said Kathryn Haslanger, CEO, Jewish Association Serving the Aging (JASA). “As the go-to agency serving and advocating for older adults in New York City, we applaud Attorney General James for making it a priority to finally put an end to those preying on older New Yorkers, especially as so many live on a fixed income. We are proud to do our part in providing seniors with resources, services, and information to help them navigate situations such as this.”


“Thank you to Attorney General James for taking meaningful action to protect New Yorkers from faulty and potentially damaging over-the-counter hearing aids,” said Wayne Ho, president & CEO, Chinese-American Planning Council. “People who use hearing aids should not be subjected to false or misleading claims of effectiveness or damage to their hearing in their search for increased affordability and access to care. Our community members have rights under New York state law, and we urge anyone who is considering purchasing a hearing aid to do their research and to exercise their rights if they feel they have been misled or scammed.”


New Yorkers who believe they have been misled or scammed by sellers of over-the-counter hearing aids are encouraged to contact the Office of the Attorney General by submitting a complaint form online or by calling (800) 428-9071.


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This release appeared on New York's State Office of the Attorney General news page.