Following a White House report arguing that the current regulation of hearing aids is stifling innovation and raising costs, FDA has scheduled a gathering to discuss the future of hearing aid regulations. The agency has also reopened a comment period on a pending draft guidance. An industry trade group, however, is skeptical of proposals that have been put forward.
FDA will host a meeting in April to discuss the prospects of exempting a segment of hearing aids from FDA's Quality System Regulation
. The agency has also reopened the comment period on a 2013 draft guidance seeking to distinguish between regulated hearing aids and unregulated personal sound amplification products.