At a time of widespread political disagreement, there seems to be consensus on at least one thing: Congressional lawmaking is moving at a plodding pace. From healthcare to infrastructure to tax reform to essentially every other national priority, we are seeing, to date, mostly incremental progress. Knowing this, it’s quite surprising to watch legislation I believe will jeopardize medical care and increase costs for millions of people move to President Trump’s desk with blinding speed.
The issue is Senate Bill 670, the Over-the-Counter Hearing Aid Act of 2017, authored by Sen. Elizabeth Warren, D-Mass. This bill means what it says – it would make hearing aids available over the counter – but it fundamentally fails the test of regulatory reliability and, most importantly, patient safety.
Warren’s bill would allow the selling of hearing aids over the counter without the aid of licensed hearing aid dealers or audiologists and outside of the purview of a medical product. At the same time, the bill will regulate (read: significantly increase bureaucratic burdens and raise prices on) personal sound amplification products (PSAPs).
For their part, PSAPs are already available over the counter, but not for use as medical hearing aids. Why? Government policy correctly recognizes they are not appropriate medical treatments for moderate hearing loss, which is defined as being unable to hear sounds softer than 40–70 dB, like a casual conversation or a ringing cellphone.
As a doctor specializing in these conditions, I am very concerned that PSAP manufacturers are seeking these new regulations to put their products on a level playing field with traditional hearing aids. PSAPs are not equivalent to the process of getting hearing aids and should not be given the veneer of such.
Here’s why: The first step in assessing whether someone should get a hearing aid is to make a diagnosis. Hearing health professionals (otolaryngologists and audiologists) do a history, physical exam and a comprehensive audiogram to help determine the cause of hearing loss. Some causes of hearing loss are progressive and preventable, some are completely reversible and others are harbingers of serious medical problems.
Second, hearing aids are highly customizable, based on the unique shape of a patient’s ear, severity of hearing loss, their audiometric configuration (low frequency hearing loss vs. mid-frequency loss vs. high frequency loss, or combinations thereof) and the molding of the hearing canal.
Finally, OTC hearing aids will inevitably lead to a lot of mis-fitted hearing aids – leading to wasted money, patient frustration and loss of confidence in our profession.
So why is this happening? The Warren bill isn’t being advanced by the medical community or hearing specialists. It’s the brainchild of the technology sector and the precision audio industry. And it’s being sold as a far-reaching and helpful “disruption” – as if treating a medical condition was the same as making a better set of Beats headphones.
That might explain why it’s moving so quickly, having already cleared the supposedly gridlocked Senate and making quick inroads in the House of Representatives. That’s where my Rep. Steve Scalise, R-La., from my home state, can now make a difference.
He should know that Louisiana is regulating the right way. While the state doesn’t mandate physician clearance for hearing aids, it does require dealer certification of anyone who fits a hearing aid – both audiologists and hearing aid dealers. Also, there is a mandatory 30-day trial period where patients can obtain a refund on any hearing aid.
Interestingly, Sam’s Club and Costco have started selling hearing aids, but products that are at least one generation behind other independent dealers. And even with their considerable purchasing power, they’re still not making a huge dent into prices or market share.
As the House majority whip and third-highest ranking Republican, Scalise is tasked with counting votes and understanding the mood of members on legislation. Here’s hoping he will learn of the risks involved in taking medical doctors and board-certified specialists out of the hearing aid process, and replacing them with Best Buy clerks, Target salesmen, and one-size-fits-all products that merely pump up the volume in what may be a uniquely damaged ear.
SB 670 may be moving like Louisiana lightning, but it needs a thorough review on behalf of every patient who stands to get hurt by its precarious provisions. Bottom line: This bill will not improve hearing healthcare, it won’t improve hearing aid prices, but it will increase the cost of PSAPs.
Gerard Gianoli (@gerardgianoli) is a contributor to the Washington Examiner’s Beltway Confidential blog. He is a physician specializing in neuro-otology and skull base surgery at the Ear & Balance Institute in Covington, La.
If you would like to write an op-ed for the Washington Examiner, please read our guidelines on submissions here.
