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FDA Listens to Calls for Affordable Hearing Aids

The FDA has issued a game changing rule that allows people with mild to moderate hearing loss to buy hearing aids over the counter rather than with a prescription.

The process started in 2015 during the Obama Administration and unfortunately progressed at a slow pace as the FDA missed deadlines. Finally, President Biden issued an executive order last year to move the agency along. That edict seems to have been heard.

Now that the medical devices will be available as OTC devices, the market will likely see a huge shift. In the next few years there will be a race as tech companies compete try to develop new hearing aids and clear their inventions through the 510(k) process. The Biden administration expects the cost of hearing aids to decrease by thousands which would make them a viable purchase to many more Americans.

See the FDA Release below.

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA

This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.