The FDA Will Soon Allow Adults to Act as Adults

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At least on one issue.

A hearing-aid disruption is under way, with inexpensive hearing aids heading to drugstores and other retailers sometime next year. But if you’re experiencing hearing loss, doctors and hearing experts say it isn’t wise to just wait for them to arrive.

The Food and Drug Administration is expected in the next few months to finalize a rule it proposed in October allowing people to buy hearing aids without getting a medical exam first. The rule would take effect 60 days after it’s published, following a public comment period that ends next month.

This is from Julie Jargon, “Over-the-Counter Hearing Ads are Coming. Here’s How to Get Ready,” Wall Street Journal, December 11, 2021.

People would be allowed to buy something based on their own judgment? Watch for chaos to follow.

Jargon goes on to say that this could reduce the price of hearing aids from thousands to hundreds of dollars. It’s not clear from her article why this is so. For that, you need to go to her link to the FDA news release. Here’s one excerpt from that release:

Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.

Today’s action follows President Biden’s July Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter. This effort also builds on the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering medical care costs for the American public.

Score one for Biden.

I still wonder, though, why this would lead to such a substantial decline in price. Google “hearing aids” and you find lots of choices already available now for just hundreds of dollars. This one at Amazon is priced at under $100.

When I post on FDA restrictions on people’s freedom to choose their own health care, I often get pushback from defenders of FDA’s tight regulations. I’m wondering if they would say that the FDA should have had those restrictions on hearing aids as long as they did and if they would say that even if the FDA restrictions should be eliminated, the rule should take 60 days to take effect.

HT2 regular reader Mark Barbieri.

This article appeared firshere

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