FDA Clarifies OTC Hearing Aid Category Does Not Yet Exist

July 25, 2018

In a letter to hearing aid manufacturers, the U.S. Food & Drug Administration (FDA) clarifies the process for establishing a new category for over-the-counter (OTC) hearing aids and the requirements that apply to them. The letter further clarifies that the OTC hearing aid category does not exist until rules are published. The FDA has until August 18, 2020, to publish proposed regulations. ASHA is actively engaged in the process.


On August 18, 2017, President Trump signed the Food and Drug Administration Reauthorization Act of 2017 (H.R. 2430) into law. As part of the law, the FDA is required to develop regulations for OTC hearing aids within the next 3 years.


For information related to audiology professional practices, contact Neil DiSarno, ASHA's chief staff officer for audiology, at ndisarno@asha.org. For information related to regulations, contact Ingrida Lusis, ASHA’s director of federal and political affairs, at ilusis@asha.org.

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