Over The Counter Hearing Aids Fda

As part of this process the fda must issue a proposed rule by august 18 2020 and a final rule within six months of the close of the comment.

Over the counter hearing aids fda.

The fda is responsible for protecting the public health by assuring the safety effectiveness quality and security of human and veterinary drugs vaccines and other biological products and medical devices such as hearing aids and over the counter hearing devices. Direct to consumer hearing aids ease some of the cost and access problems that led a team of researchers to recommend that the fda create the new over the counter hearing aid category. The change comes thanks to a federal law passed in 2017 directing the u s. July 24 2018 status on over the counter otc hearing aids.

Beginning next year if not sooner consumers should have access to over the counter otc hearing aids that are expected to bring down the price and hassles associated with purchasing one. Hearing loss affects millions of americans but high costs prevent many from purchasing hearing aids. Later this year the fda is expected to release requirements for over the counter otc. A law established on august 18 2017 as part of the fda reauthorization act of 2017 directed the fda to create a category of otc hearing aids for adults who might have mild to moderate hearing loss.

In the fda reauthorization act of 2017 fdara congress outlined certain requirements to establish a category of over the counter.