The FDA Highlights Hearing Aids - New Site on What You Should Know - You Don't Need a Prescription for OTC Hearing Aids

Mark Hake

The Food and Drug Agency (FDA) recently created a new website on What You Should Know about Hearing Aids.

The site says that 30 million Americans have some degree of hearing loss. But only about 20% of those who could benefit from a hearing aid seek intervention.

Over-the-Counter (OTC) Hearing Aids Don't Require a Prescription

For example, not many people know that the FDA established a new category of over-the-counter (OTC) hearing aids for adults 18 years of age and older with perceived mild to moderate hearing loss.

This OTC category went into effect on October 17, 2022, and means that pharmacies and stores can sell OTC hearing devices without a prescription. In effect, you don't need a prescription anymore to buy an OTC hearing aid.

This is for adults with signs of mild to moderate hearing loss, for example, if you

  • have trouble hearing speech in noisy places
  • find it hard to follow speech in groups
  • have trouble hearing on the phone
  • get tired just listening
  • need to turn up the volume on the TV or radio, and other people complain it’s too loud

OTC hearing aids are limited in their maximum output and may not be adequate to treat more severe hearing loss. 

OTC hearing aids amplify (via air conduction) sound into the ear canal. They help sound waves move through the eardrum and three tiny bones in the middle ear. It then reaches the inner ear, where it’s processed and sent to the brain.

However, for those who can't hear sound even when the room is quiet and/or those who can't hear loud sounds well, they should not use an OTC device. They need to seek medical help to potentially get a surgical ear plant.

The bottom line - the FDA wants the public to know that OTC devices are now available online and in stores for adults with hearing aid issues.


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Mark R. Hake, CFA, writes articles on national and local news, stocks, and market events at,,, and as well as TalkMarkets.

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Mark Hake is a financial analyst, investor, and Chartered Financial Analyst (CFA). He writes about US and foreign stocks as well as cryptos, hedge funds, and private equity. He previously ran his own hedge fund, investment research firm, and acted as CFO for a fintech startup. He focuses on finding value, arbitrage, and hidden asset opportunities.

Phoenix, AZ

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