FDA Moves to Stop Marketing of OTC Devices as ‘Hearing Aids’ In a letter to hearing aid manufacturers, the U.S. Food and Drug Administration (FDA) cautioned them against marketing their products as an over-the-counter (OTC) hearing aid. In the letter, William Maisel, the chief medical officer of the FDA’s Center for Devices and Radiological Health, says that the OTC hearing aid ... News in Brief
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News in Brief  |   October 01, 2018
FDA Moves to Stop Marketing of OTC Devices as ‘Hearing Aids’
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Hearing & Speech Perception / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   October 01, 2018
FDA Moves to Stop Marketing of OTC Devices as ‘Hearing Aids’
The ASHA Leader, October 2018, Vol. 23, 14. doi:10.1044/leader.NIB4.23102018.14
The ASHA Leader, October 2018, Vol. 23, 14. doi:10.1044/leader.NIB4.23102018.14
In a letter to hearing aid manufacturers, the U.S. Food and Drug Administration (FDA) cautioned them against marketing their products as an over-the-counter (OTC) hearing aid.
In the letter, William Maisel, the chief medical officer of the FDA’s Center for Devices and Radiological Health, says that the OTC hearing aid category does not exist. Until it is established, “no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids … Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements.”
He emphasized that marketing of hearing devices cannot use the phrase “OTC hearing aids,” because the FDA definition of this hearing aid class—which would probably include severity of loss and other safety, quality and labeling requirements—has not yet been established.
The proliferation of hearing devices marketed as “OTC hearing aids” follows the FDA Reauthorization Act of 2017 (FDARA), which enacted a definition, outlined certain requirements, and set forth a process for establishing a category of OTC hearing aids.
The FDA has until August 18, 2020, to propose new regulations that will define and regulate the new OTC hearing aid device category, followed by a public comment period. New regulations are required within 180 days after the comment period closes.
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October 2018
Volume 23, Issue 10