The US House of Representatives has adopted the law containing the proposed bill on the unrestricted sale of certain hearing aids


© dkfielding -

OTC – The debate has been at the heart of audiology in the United States for the last few months. The outcome is near since the over-the-counter sale of certain hearing aids is now another step closer to becoming a reality, through the approval of the FDA MDUFA package.

The US House of Representatives (the lower chamber of the United States Congress) adopted the Medical Device User Fee Amendments (MDUFA) package on July 12. The law includes several bills, including the much-debated OTC Bill. The text provides for the creation of an over-the-counter hearing aids category for products that would be available without restriction to people who have mild-to-moderate hearing loss. Under this new legislation, people with this type of hearing impairment will no longer need a medical prescription to buy hearing aids indicated for their condition. The text now moves on to the US Senate and is likely to be adopted definitively before the end of the summer.