FDA Clears Sale Of Over-the-counter Hearing Aids This Fall

With a long-pending rule getting the clearance on Tuesday, millions of Americans will now be able to purchase hearing aids without a prescription later this fall.

The Food and Drug Administration or FDA said that the new regulation reduces red tape by creating a new class of hearing aids, which do not need a medical examination, a prescription and any other specialty evaluations. Instead, the devices will now be sold online or over-the-counter at pharmacies and other retail stores.

The devices are meant for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. The FDA first proposed the rule in last October and it will be effective from mid-October.

The Biden administration highlighted the potential cost savings of the new rule. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra, said in a statement.

The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.

The cost of hearing aids is a big concern nowadays as between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests.

The new over-the-counter status will not be applicable for more severe hearing loss, which will remain prescription only.

The FDA said that it altered several parts of its initial proposal in response to public comments, including clarifying on how the federal rule will impact state regulations on hearing aids.

Once the federal rule takes effect, traditional manufacturers are expected to begin selling cheaper, direct-to-consumer models. Eventually, advocates predict the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.

Tuesday’s announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices.

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