WASHINGTON, DC — The US House of Representatives, as expected, passed the FDA Reauthorization Act today. The legislation, as reported previously, contains 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.
According to an announcement on the developments by the American Academy of Audiology, the version of the bill passed by the House of Representatives today contains additional modifications from its original language to “further ensure safety and efficacy of OTC devices, including requiring the FDA to create a Web site to report on the continued quality, safety, and effectiveness of devices with respect to servicing of OTC devices”.
The bill now heads to the Senate floor for consideration where the bill, including the OTC hearing aid provision, passed out of the HELP committee by a nearly unanimous vote in early May. The timing of the Senate vote is unknown, but is expected to happen by September.
HLAA and CTA Hail Passage of OTC Legislation
OTC Hearing Aid logo that will be found on future devices that meet the new ANSI standard developed by CTA
The Hearing Loss Association of America (HLAA) has been a strong supporter of the legislation since it was first introduced and applauded the passage in the House of Representatives today. The organization is said to be currently working with the FDA on labeling of OTC products, product safety and consumer protection.
The Consumer Technology Association (CTA), which has strongly lobbied for OTC hearing devices, also hailed the passage of the bill through the House. The organization recently unveiled a new logo for OTC hearing aids, to act as a “seal of approval”, to help consumers “distinguish high-quality hearing enhancement devices for mild to moderate hearing loss from the cheap, ineffective personal amplifiers commonly found today”.
“We applaud Reps. Marsha Blackburn, R-Tenn., and Joe Kennedy III. D-Mass., for working with House Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Ranking Member Frank Pallone. D-N.J., to successfully advance the over-the-counter provision in the broader FDA user fee legislation. With this kind of bipartisan momentum in the House, we are hopeful that the Senate will continue to push this legislation as expeditiously as possible.” –Gary Shapiro, CTA President and CEO
CTA currently represents more than 2,200 companies involved in the consumer electronics industry, including manufacturers, distributors, technology developers, retailers, dealers, and integrators.
Gun Groups Reassured After Language Change
As previously reported by HHTM, gun groups had expressed their opposition to the OTC hearing aid legislation out of fears that it would allow additional “federal regulation” of the hunting industry. The 1.5 million-member strong, Gun Owners of America, and its other allied organizations, pushed back against the bill over cocners certain hunting products could be regulated, specifically Personal Sound Amplification Products (PSAPs) which are used by many hunters to listen to game.
Following the criticism, one of the original co-sponsors of the bill, Senator Chuck Grassley, indicated the language in the bill could be modified to alleviate concerns.
According to a report in the Daily Caller, the House version of the bill that passed on July 12th included an amendment by North Carolina Republican Rep. Richard Hudson to do just that.
“Today’s bill is critical because it will keep the innovation pipeline for cures, treatments and drugs open for patients. Additionally, it includes my language that protects hearing enhancers and devices used by hunters and bird watchers from potential bureaucratic government overreach. It’s a small win for common sense, our freedoms and our Second Amendment rights” –Rep. Richard Hudson, R-NC
The full FDA Reauthorization Act of 2017 report can be read here.
**HHTM has extensively reported on the developments surrounding the Over-The-Counter Hearing Aid Act since it was first introduced. We will continue to bring you the latest news and opinion surrounding the issue of OTC hearing aids, so please stay tuned and visit often for the latest updates!
