Over The Counter Hearing Aids Fda

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.

Over the counter hearing aids fda.

Over the counter otc hearing aids are a new category of hearing aids that will soon be available for purchase in stores and online without a prescription. The new category of products will provide an alternative amplification option for adults with mild or mild to moderate hearing loss. 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. 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.

In the fda reauthorization act of 2017 fdara congress outlined certain requirements to establish a category of over the counter. July 24 2018 status on over the counter otc hearing aids. Later this year the fda is expected to release requirements for over the counter otc. Food and drug administration fda to ease barriers to buying a hearing aid.

Hearing loss affects millions of americans but high costs prevent many from purchasing hearing aids.