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Connecticut AG Tong Doesn’t Want to Hear Claims that Over-the-Counter Hearing Aids Are “FDA-Approved”

  • Connecticut AG William Tong announced that his office has settled with four over-the-counter hearing aid companies: Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., and Wonder Ear, Inc. (collectively, “OTC Companies”), over allegations that the OTC Companies misleadingly marketed their hearing aids as “FDA-approved.”
  • According to the AG’s office, while hearing aid companies are required to register their products with the FDA, hearing aids do not undergo the same review and approval process as pharmaceuticals and medical devices, and any claim that such products are “FDA-Approved” is misleading. Although federal law permits the FDA to create such a process for hearing aids, the agency has not yet done so.
  • Under the terms of the settlements, the OTC Companies will collectively pay $40,000 in fines, and must remove the “FDA-approved” language from their marketing materials.