ATTORNEY GENERAL TONG ANNOUNCES SETTLEMENTS WITH FOUR OVER-THE-COUNTER HEARING AID COMPANIES
(Hartford, CT) – Attorney General William Tong announced today four separate settlements with over-the-counter hearing aid companies Lively Hearing Corporation, Widex USA, Inc., 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 U.S. Food and Drug Administration. 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.” The…
