Tomorrow, FDA will issue a revised draft guidance on Hearing Aids and Personal Sound Amplification Products (PSAP) (here), and is also publishing a proposed rule for the over the counter (OTC) classification of hearing aids (HA) and PSAP (here) entitled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids”. These are the prepublication versions for your review.
The draft guidance document entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products” explains the regulatory difference between a HA and a PSAP and acknowledges that a proposed rule is being concurrently issued. This draft guidance is a 10-pager and quite informative. The proposed rule is 114 pages and outlines the FDA’s thinking on the why, what, and how the Agency intends to transition some devices to OTC status. Because this is a rule making process, do not expect to see an OTC HA any time soon in a store near you; however, it is a delight to know that there is a path forward to decrease the cost and access of HAs for the general public.