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FDA Approves Over the Counter Hearing Aids, ‘A Game Changer’ For Millions

A long-awaited regulatory change was announced by the US Food and Drug Administration in August, bringing in choices for those with hearing loss that ought to be less expensive and perhaps even better.

Adults can now buy hearing aids directly from a store or online without a prescription or a personalized fitting from a hearing aids healthcare specialist. According to some experts, these over-the-counter devices could help 90% of those with hearing loss.

Due to the high cost of hearing aids, many people choose not to use them. The National Institute on Deafness and Other Communication Disorders says, just 16% of the tens of millions of people with hearing loss utilize hearing aids.

There are many people who have hearing loss. Hearing loss affects both ears in around 1 in 8 Americans aged 12 and older, and the prevalence rises sharply with advancing years. Hearing loss affects about 25% of adults between the ages of 65 and 74, increasing to 50% by 75.

According to a published survey, consumers shell out at least $4,000 out of pocket for hearing aids for both ears. Large merchants may sell a pair for around $1,400, but depending on the technology, some might cost as much as $6,000 per ear.

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