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regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).
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:
- August 3, 2017: US Senate Passes OTC Hearing Aid Legislation
- July 12, 2017: OTC Hearing Aid Legislation Passes Through House, Awaits Senate Approval
- June 27, 2017: Consumer Technology Association Unveils New Logo for OTC Hearing Aids at HLAA Convention
- June 14, 2017: Florida Congressman the Latest to Co-Sponsor OTC Legislation, Despite Negative Ad Campaign Targeting GOP Support
- May 25, 2017: Another Prominent US Senator Co-Sponsors OTC Hearing Aid Bill
- May 10, 2017: OTC Hearing Aid Legislation Merged with FDA Bill, Now “Much More Likely” to Pass
- March 21, 2017: Over-the-Counter Hearing Aid Act Re-introduced into New Congress
- December 9, 2016: ADA Supports OTC Hearing Aid Bill; AAA Applauds FDA Decision to Eliminate Waiver
- November 7, 2016: US Senators Warren and Grassley to Introduce “Over-the-Counter Hearing Aid Act of 2016”
**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!