Zdrowie i gospodarka · 17/08/2022

FDA Releases Final Guidance on Hearing Aid Devices and Personal Sound Amplification Products

The Food and Drug Administration (FDA) has released a final guidance document outlining the regulatory requirements for hearing aid devices and personal sound amplification products, following a 2017 directive from the FDA Reauthorization Act. The guidance supersedes a 2009 document and fulfills a requirement to update the original draft issued in 2013.