Connecticut (CT) Attorney General William Tong announced four separate settlements with over-the-counter hearing aid companies Lively Hearing Corporation, Widex USA, Hark Wellness, Inc, and Wonder Ear, Inc, who marketed their products as “FDA-approved” despite no such approval.
Hearing aids currently do not require, and do not receive approval from the US Food and Drug Administration (FDA). While hearing aid manufacturers register their products with the FDA, hearing aids do not currently undergo pre-market approval the way new drugs and some medical devices do. Although Congress enacted legislation in 2017 permitting the FDA to create a category of over-the-counter hearing aids, the FDA has not yet issued a final rule and no hearing aid suppliers should be marketing their products as “FDA-approved,” according to the announcement. The Office of the Attorney General opened an investigation into these over-the-counter hearing aid companies out of concern that consumers would be misled by the “FDA-approved” language into believing that their hearing aids received a government endorsement or approval that they had not, the announcement reads.
“These companies marketed their products as ‘FDA-approved’ when they were not. Over-the-counter hearing aids may be fine options for certain adults with mild-to-moderate hearing loss, but there is no federal approval of these products right now. Consumers need to research these products thoroughly before spending their money on a product that may or may not provide safe, effective, or meaningful hearing assistance,” said Tong. “Our investigation is ongoing and any company marketing these hearing devices as FDA-approved should expect to hear from our investigators.”
Collectively, the four companies will pay $40,000 in fines to the state and have agreed to cease marketing their products as “FDA- approved.” Specific agreements are outlined below.
Lively Hearing Corporation is a direct-to-consumer hearing aid company located in New York which sold over $200,000 worth of hearing aids to over 100 CT consumers between January 1, 2017 and June 30, 2021, according to the announcement. They will make a payment to the state of $15,000.
Widex USA, Inc is a wholesale hearing aid company located in New York which sold over 21,000 hearing aids valued at over $13 million in CT between January 1, 2017 and January 4, 2022, the announcement says. They will make a payment to the state of $15,000. However, Widex has stated that the issue arose when the Connecticut AG identified one instance where the term “FDA-approved,” instead of “FDA-registered,” was used on the Widex Authorized Dealer and Warranty Statement business terms webpage. The company corrected the mistake as soon as it was identified, and the Connecticut State AG’s office offered to resolve and close the matter with no finding of wrongdoing, provided the company paid $15,000 to reimburse them for investigatory costs.
Hark Wellness, Inc is a direct-to-consumer hearing aid company located in New York which reported that it had not sold to any CT consumers, according to the announcement. They will make a payment to the state of $10,000.
Wonder Ear, Inc was a direct-to-consumer hearing aid company located in New Jersey which stopped operating when contacted by the Office of the Attorney General, according to the announcement. It had not yet done any business in CT and was not required to make a payment to the state.
The Office of the Attorney General has previously provided these tips for consumers when considering over-the-counter hearing aids:
- The FDA has not approved any over-the-counter hearing devices. Over-the-counter, direct-to-consumer, hearing aids are not regulated like many other medical devices and because of this, may work poorly or not at all and could be harmful.
- Research the seller with the Better Business Bureau to see if they have a good rating before you purchase the product.
- Be skeptical of online reviews and endorsements.
- Read the purchase policy carefully. Can you get a refund if they don’t work? How long do you have to make a return if necessary?
- If you can, get a health screening and discuss your options with a medical professional. They will be able to tell you exactly what kind of hearing device would work for you and make recommendations.
Assistant Attorneys General Joseph Gasser and Jon Blake and Consumer Protection Section Chief Mike Wertheimer assisted the Attorney General with this matter.
Updated March 24, 2022, 2:50 PM
Source: The Office of Attorney General William Tong