Author : Ben Orenstein, BSEE, MBA
WASHINGTON, DC — On Friday, August 18, President Trump signed the FDA Reauthorization Act into Law. Within the FDA legislation, a provision was included that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. After passing in the Senate earlier this month by a vote of 94-1, the president was expected to sign the legislation.
The OTC provision of the legislation, better known as the Over-The-Counter Hearing Aid Act, will allow hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. The bill requires the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids within the next three years, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).
“We appreciate President Trump signing this critical reauthorization into law. This law will encourage new medical innovations, bring lower cost drugs to market faster, improve the regulatory review process for devices and treatments and, most importantly provide certainty to patients and the health industry. Paired with the implementation of the 21st Century Cures Act, this law continues to deliver much needed hope to patients everywhere.” –Greg Walden (R-OR), Frank Pallone, Jr. (D-NJ) and Gene Green (D-TX)
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