On July 9th, 2021, The White House Briefing Room made the announcement that a new executive order had been set in motion with the intention to promote competition throughout the US economy.
Within this order, President Biden has directed the Department of Health and Human Services (HHS) to “consider issuing proposed rules within 120 days” in relation to over-the-counter (OTC) hearing aids.
“Today’s historic Executive Order established a whole-of-government effort to promote competition in the American Economy. The Order includes 72 initiatives by more than a dozen federal agencies to promptly tackle some of the most pressing competition problems across our economy,” the announcement read.
Among the initiatives outlined, the executive order incorporates mandates to ban and limit occupational licensing agreements and non-compete agreements, lower prescription medication prices, ban excessive internet service-related early termination fees, and make it significantly easier to switch banks. The mandates also address the long-neglected issue of accessibility when it comes to OTC hearing aids.
Breaking up anti-competitive markets
The Biden administration is arguing that a select few large market players have been controlling too much of the sector in areas such as hearing aids, internet services, and prescription drugs.
The administration has also made the prediction that the availability of OTC hearing aids will “save Americans with hearing loss thousands of dollars by allowing hearing aids to be sold over the counter at drug stores.”
The new mandates argue that a considerable cost to the consumer is unnecessary when it comes to acquiring hearing aids from doctors or specialists, as experts agree that such medical evaluation is not typically necessary. As such, this drawn-out and expensive process is only serving as an unnecessary, red-tape barrier when it comes to more companies being able to manufacture and sell hearing aids. Currently, the four largest manufacturers of hearing aids control a massive 84% of the market.
OTC hearing aid market accessibility
The direct-to-consumer (DTC) marketplace for hearing aids is certainly alive and well. One quick google search like ‘online FDA hearing aids’ will bring up a myriad of accessible options, both with and without any remote, licensed practitioner support. Simply put, this market is actually highly unregulated, and it is already quite easy to access alternative products to the traditional practitioner route.
Incidentally, the incredibly popular Apple Airpods Pro already features hearing-aid style controls, such as background noise reduction and personalized amplification, with an additional hyper-directional beamforming microphone feature in the pipeline. While they are limited in their capabilities for amplification, the Airpods Pro retail at around $249, with hundreds of millions of units sold.
Meanwhile, Bose hearing aids have recently been launched and FDA-approved, available directly to consumers. Called the Bose SoundControl, this product has been approved under a new product classification for hearing aids that are self-fitted. Many industry experts are predicting that the FDA’s new OTC rules for hearing aids will closely resemble these guidelines.
Enhancing OTC hearing aid regulations
It may be a surprise to learn that many DTC hearing aid products are already registered with the FDA under medical-model-related classifications for hearing aids. If the FDA enforces that any DTC sellers must reclassify their hearing aid products to a new OTC class and thus require new product clearance, many of the current FDA-approved, DTC hearing aids available may be temporarily pulled from the market.
Ultimately, this could be a good thing for hearing aid consumers, as it would lead to an enhanced quality of FDA protection, with manufacturers being required to prove both the safety and effectiveness of their devices. By removing audiologists from the process of expertly fitting patients themselves, the FDA should assume a greater level of responsibility when it comes to vetting any new products before allowing them to be sold, but only time will tell if this will come to fruition.
How long before the final regulations will be released?
A change to these regulations has gone through a series of fits and starts ever since President Trump originally signed the Over the Counter Hearing Aid Act back in August 2017, but this latest announcement does indicate that it is likely to proceed quickly from here on out.
Hearing Industries Association (HIA) President, Kate Carr, commented that “once the draft is released, we anticipate a public comment period, followed by further FDA review.” She went on to estimate that it could take a further nine months or more before the final regulations are formally released.
This isn’t the first time that the FDA has scheduled to work on these rules - they have planned to do so five times before. That said, this latest announcement direct from the Whitehouse is as clear an indication as any that this time the session will hold firm.
If you hold shares in any of the largest hearing aid manufacturing companies, you may not be rejoicing, with Sonova, the sector’s largest player, announcing a 7% drop in share prices following the announcement. But, if you’re in the market for hearing aids, it should only be a relatively short period of time before buying quality, FDA-approved OTC hearing aids becomes a reality.
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