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!
Without an appropriate case history, otoscopic exam, hearing evaluation, and professional guidance there is no safety, there is no efficacy, there is nothing of value to the hearing impaired consumer. From the start this was a Trojan Horse built on falsehoods and oversimplifications. The rate of hearing aid market penetration is actually closer to 60% of the real market–the 15% figure is totally made up and without foundation. Not every hearing impaired person is in “the market” for a hearing aid.
And with hearing centers distributed in every nook and cranny in the United States, accessibility has never been an issue. PCAST members have fed the public a bill of goods on that one.
Cost? You can buy a solid, basic hearing aid WITH everything that is missing in this bill (hearing test etc.) for the price of what the OTC Hearing Aids will cost. With all of the charitable programs, low cost instruments from licensed professionals available, this, too, has been one huge lie.
Now, the elephant in the living room is this: The dastardly ignoramuses who are shoving this awful legislation down our throats are hell-bent on unleashing an army of unlicensed dispensers on an unsuspecting public to compete with the licensed professional. Why bother with licensing when you can fit 85% of the hearing impaired without it? And you don’t have to do a thing but hand over the merchandise and collect the money. What a crooked scheme that is. Japan’s and China’s experience is about to become ours!
So, while the smug proponents treat this issue as business as usual, the valiant professionals who built their practices by the rules are about to be thrown to the wolves. Already many are complaining about prospects being told to wait until the cheapies are available at their local Wal-Mart. There go a lot of jobs and a lot of small businesses. And where does the money go? Overseas to the electronic giants that bribed our senators and congressmen to not listen to the reasoned arguments put forth against this awful bill. Corruption at its best.
But the fight is not over. We can still stop this thing with an informed White House before it’s signed into law.
I agree one hundred percent! And the sad truth is that Audiologist that spent 8 years getting a doctorate degree to provide the hearing impaired public with an educated professional are now thrown in the same arena as untrained dispensers selling the general public OTC products that are not viable products.
Hearing healthcare is more complicated than purchasing an amplifier. It is about testing and diagnosing the patient’s hearing loss and finding the correct treatment and recommendations for that patient. If the patient does not need a referral for medical treatment, then the audiologist must find the “appropriate” product for the patient and validate that the hearing aid is fit correctly.
We already have entry level technology that is available to our patients and we fit and support these aids to make sure our patients are successful we these products. I have to question the real reason that this bill needs to be passed?
In addition, there are personal sound amplifiers that are already being sold on the market, so why do we need this bill? The only reason I can see is to promote these products for the companies that are manufacturing them. They want another “arena” to move their products, so instead of selling them at Best Buy or Walmart they can now promote them in professional offices even though the end product has not improved!