will be able to buy a hearing aid without a doctor’s exam, prescription, or fitting adjustment.
President Joe Biden announced in 2021 he intended to allow hearing aids to be sold over the counter without a prescription to increase competition among manufacturers. Congress also passed bipartisan legislation in 2017 requiring the FDA to create a new category for hearing aids sold directly to consumers.
The new over-the-counter hearing aids will be considered medical devices. To avoid confusion, the FDA between hearing aids and personal sound amplification products . For example, PSAPs are considered electronic devices designed for people with normal hearing to use in certain situations, like birdwatching or hunting.FDA: “FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans.”
Excellent development. Well done!!
'more affordable' 🤔
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