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FDA allows access to over-the-counter hearing aids

Updated: Sep 24, 2022

The U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. 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.

A new class of hearing aids

While OTC hearing aids won’t require consultation with a medical professional or a hearing test, pharmacists will play an important role in ensuring their safe and effective use.

Pharmacists will now be able to help people who need it, the right hearing aid. Pharmacists are among the most accessible health care providers, trained to identify, prevent, and resolve Over the Counter (OTC) problems. Pharmacists have also long helped patients buy medical devices and equipment without a prescription, so this is not a new challenge for them.

These medical devices are approved by the FDA and their regulation is strict, helping to ensure patient safety.

If you are a manufacturer of hearing aids, now is the best time to register your medical device with the FDA.

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