Connecticut Attorney General William Tong announced four separate settlements with 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 receive approval from the United States Food and Drug Administration (FDA) in the same manner as new drugs and some medical devices; however, hearing aid manufacturers register their products with the FDA.

Although Congress enacted legislation in 2017 permitting the FDA to create a category of over-the-counter (OTC) hearing aids, the FDA has not yet issued a final rule and no hearing aid suppliers should be marketing their products as OTC or “FDA-approved.”

Review the full press release.

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