April 25, 2024

AG Tong Announces Settlements with Four Over-The-Counter Hearing Aid Companies | Connecticut Law Tribune – Law.com

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Attorney General William Tong has announced 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 ai…….

Attorney General William Tong has announced 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.

Source: https://www.law.com/ctlawtribune/2022/03/14/ag-tong-announces-settlements-with-four-over-the-counter-hearing-aid-companies/

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