Editor’s Note: On August 3, 2017, the US Senate passed the Over the Counter Act of 2017. The legislation, having already passed in the House, will now head to the president’s desk to be signed into law.

 

In November 2016, citing recommendations from the groundbreaking PCAST and NAS reports on hearing aid accessibility and affordability, US Senators Elizabeth Warren and Chuck Grassley introduced the “Over the Counter Hearing Aid Act of 2016” in the Senate. The bipartisan legislation’s aim was to make certain types of hearing aids available over the counter (OTC) and “remove unnecessary and burdensome requirements that currently create barriers for consumers who could benefit from hearing aids”.

The legislation would allow for hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. The bill also requests the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).

Over the next several months, the legislation had undergone revisions and a version of the bill was introduced in the US House of Representatives.

otc hearing aid logo

OTC Hearing Aid logo that will be found on future hearing devices that meet the new ANSI standard developed by the CTA

On July 12th, 2017, the US House of Representatives, passed the FDA Reauthorization Act. The FDA legislation contained a provision that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss.

In the US Senate, after FDA legislation containing the OTC hearing aid provision passed out of the HELP committee by a nearly-unanimous vote in May, the legislation will be heading to the Senate floor for a vote. The ultimate timing of the Senate vote remains unknown, but many anticipate it will happen by the end of September.

 

OTC Hearing Aid Timeline

 

For your reference, a timeline is offered below featuring stories relevant to the OTC hearing aid legislation:

 

 

**HHTM has reported extensively on the developments surrounding the Over-The-Counter Hearing Aid Act since it was first introduced in the fall of 2016. We will continue to bring you the latest news and opinion regarding the issue of OTC hearing aids, so please stay tuned and visit often for the latest updates!

 

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