President Biden issued an executive order directing the FDA to implement immediately the FDA Reauthorization Act in 2017.
This act customers access to affordable devices without a doctor’s visit or prescription, and the Food and Drug Administration (FDA) finalized its decision to create a new category of over-the-counter hearing aids.
In the United States, almost 30 million adults today require hearing aids due to some degree of hearing loss. But since they typically cost between $4,000 and $6,000 per pair, not everyone can afford to own one.
A medical examination, prescription, and fitting by an audiologist are necessary before purchasing a hearing aid. The 2017 FDA Reauthorization Act requires a new category of over-the-counter hearing aids.
But the three-year window that was first specified passed without a new decision. Therefore, President Biden signed an executive order in July 2021 directing the FDA to start enforcing the 2017 mandate right away, according to the Benzinga report.
The FDA delivered its final decision in August 2022 in accordance with the executive order, allowing OTC hearing aids to be marketed for the first time in stores and online without a prescription or medical exam.
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Over-the-Counter Hearing Aids
A new line of over-the-counter (OTC) rechargeable hearing aids was introduced by InnerScope Hearing Technologies in December 2022 on CVS.com, the online storefront for CVS Health Corp. Just a few weeks have passed since the FDA finalized its decision to create a new category of over-the-counter hearing aids before the launch.
With the introduction of the iHEAR OTC Hearing Aids on CVS.com, InnerScope now has access to a considerably larger market and distribution network through CVS Health, the biggest chain of pharmacies in the United States.
The most recent in hearing aid technology is available with InnerScope’s iHEAR OTC Rechargeable Hearing Aids, which include models with Bluetooth wireless app control via a smartphone or tablet.
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