WASHINGTON, DC — Prominent US Senators, Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), announced today that they will introduce the Over-the-Counter Hearing Aid Act of 2016 when the US Senate returns to session.
Citing recommendations from the recent PCAST and NAS reports on hearing aid accessibility and affordability, the bipartisan legislation would 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”.
Major Changes Proposed for Hearing Aid Industry
According to the press release, the Over-the-Counter Hearing Aid Act of 2016 would allow hearing aids that are “intended to be used by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. Furthermore, it would also eliminate the requirement that people get a medical evaluation or sign a waiver in order to obtain hearing aids.
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regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).
“If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. More consumer choice and convenience are what we want to accomplish with this legislation.
This won’t affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted. The over-the-counter option is for those who would benefit from a simpler device.”
—Sen. Chuck Grassley (R-Iowa)
Over-the-Counter Hearing Aid Act of 2016
According to a Fact Sheet released by the Senator’s office, the proposed legislation seeks to make hearing aids more accessible and affordable for millions of Americans with hearing loss by taking the following steps:
- Make hearing aids intended to be used by adults to compensate for mild to moderate hearing impairment available over the counter.
- Remove requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid.
- Require the FDA to issue regulations containing safety and labeling requirements for new category of OTC hearing aids.
- Require the FDA to update its draft guidance on Personal Sound Amplification Products (PSAPs), which are consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing.
***Please stay tuned for more on this developing story!