otc hearing aids fda rule

Final OTC Hearing Aid Regulations Inch Closer to Reality After White House OMB Concludes Review

The long-awaited Over the Counter (OTC) hearing aid regulations appear to have taken a step closer to reality this past week. On August 5th, the White House Office of Management and Budget’s OIRA department (Office of Information and Regulatory Affairs) completed its review of the final rule.

According to OIRA, the final OTC rule was found to be consistent with the principles set forth in President Biden’s Executive Order last July.

Many within the industry are anticipating the FDA to put forth the final rule soon, perhaps within days.

 

OTC Hearing Aids Poised to Change the Industry

 

First introduced in 2016 by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), Congress ultimately passed a bill in 2017 directing the U.S. Food and Drug Administration (FDA) to develop regulations for a new category of OTC hearing aids.

The OTC provision of the legislation, better known as the Over-The-Counter Hearing Aid Act, would allow hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. Additionally, the bill directed the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids within the next three years. However, the FDA failed to meet the 2020 deadline and has yet to issue the proposed rules, which prompted criticism from Senators Warren and Grassley, as well as number of consumer advocacy groups.

In October 2021, the FDA released a draft OTC rule and opened a comment period for stakeholders to provide the FDA with feedback on potential changes to the bill. Many are anticipating the final rule will be similar to the draft proposal. 

The draft OTC hearing aid rule was discussed at length at the 2021 Academy of Doctors of Audiology conference, and the presentation by Dr. Tom Tedeschi can be viewed below for interested readers:

 


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