The Food and Drug Administration has at last finalized a rule that allows the sale of over-the-counter hearing aids. This is a big f+#$king deal. Until now, Americans with hearing loss have had to see an audiologist and pay a king’s ransom in order to hear better. Most people could not afford the cost or the hassle.
The final FDA rule to allow the sale of over-the-counter hearing aids will help meet the needs of people with mild to moderate hearing loss. They would no longer need a prescription or a visit to the audiologist to get the hearing aid. These hearing aids will be available in October 2022 when the law takes effect.
The new rule should force more competition in the hearing aid marketplace. With 38 million people saying they have some hearing loss, the market is huge. President Biden believes the cost of hearing aids will drop enormously. And, the technology will become more sophisticated.
It’s baffling that it has taken the FDA so many years to finalize the rule on over-the-counter hearing aids. The policy has been around for some time now. Congress directed the FDA to propose a rule in 2017 and gave it three years. The FDA missed the deadline.
It’s not unlikely that hearing aid manufacturers exercised their leverage to stall the FDA rule-making process. For sure, when Senator Bernie Sanders was leading the charge to include a hearing benefit in Medicare last year, the hearing aid industry in collaboration with the White House and many Democrats insisted that the benefit pay a non-discounted rate for hearing aids, driving up costs and helping to kill the benefit.
Democratic members of Congress would not agree to Medicare’s bulk purchasing of hearing aids. The VA does bulk purchasing and pays about $500 for a pair of hearing aids. Lawmakers also would not agree to competitive bidding for hearing aids. Insanity.
Note: For information on hearing aid options, check out this article in the New York Times WireCutter. If you need a hearing aid and cannot afford one, there are free and low-cost options for addressing hearing loss. Also, keep in mind that personal sound amplification devices (PSAPs) are already available but are different from hearing aids. Hearing aids amplify sounds in more targeted ways that tend to work a lot better.
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