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Hearing Services - OTC and Much More

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Get the Facts

Red Flags

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What Are Over-the-Counter (OTC) Hearing Aids?

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Over-the-counter hearing aids are devices that consumers can buy directly from traditional retailers and pharmacies without the need for a visit to a hearing health professional.

Why Are Hearing Aids Now Being Offered Over the Counter?

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In 2017, Congress passed bipartisan legislation requiring the U.S. Food and Drug Administration (FDA) to create a category of OTC hearing aids, but it was not fully implemented until now, with OTC hearing aids available in traditional retail and drug stores as soon as October 17, 2022, when the rule took effect.

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Who Is a Good Candidate for OTC Hearing Aids versus Prescription Hearing Aids?

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OTC hearing aids are for adults 18 years of age or older who think they have mild-to-moderate hearing loss. You may have mild-to-moderate hearing loss if, for example:

  • Sounds or speech seem quiet or muffled to you.

  • You have difficulty hearing in a group setting, with background noise (e.g., restaurant), speaking on the phone, or need to face people when talking to understand them.

  • You ask others to repeat themselves or speak more loudly.

  • People complain that you turn up the TV or radio too high. aid.

Can Children Use OTC Hearing Aids?

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Currently, the FDA regulations state that OTC hearing aids are for adults (18 years of age or older). Children should see a hearing health professional for evaluation and obtaining a hearing aid.

What Are FDA "Red Flag" Conditions and What Do They Mean?

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The list below describes conditions that need medical attention to prevent additional problems and complications. You should see a doctor—preferably an ENT specialist—if you have any of these red flag conditions indicating that there is a medical condition causing your hearing loss, including:

  • Your ear has a birth defect or an usual shape or your ear was injured or deformed in an accident.

  • You have had blood, pus, or fluid coming out of your ear during the past six months.

  • Your ear feels painful or uncomfortable.

  • You have a lot of ear wax, or you think something could be in your ear.

  • You feel dizzy or have a feeling of spinning or swaying (called vertigo).

  • Your hearing changed suddenly in the past six months.

  • Your hearing gets worse then gets better again.

  • You have worse hearing in one ear.

  • You hear ringing or buzzing in only one ear.

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Who Should I Talk to If I Have Questions About OTC Hearing Aids?

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If you need help deciding if you have hearing loss, if OTC hearing aids are right for you, or if you need prescription strength hearing aids, a hearing specialist—ENT specialist or an audiologist—can help you. Tell them if you are experiencing any red flag conditions listed above. And be sure you know the return policy of the OTC hearing aid you are considering.

What Technological Issues Should I Consider?

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Different OTC hearing aids will offer different features, may be programmable, and will likely be offered at different price points, but most OTC hearing aids will probably be compatible with other devices. If compatibility is important to you, be sure to check if your OTC hearing aids will work with your smart phone before purchasing them.



Audiologists are doctoral-level healthcare professionals who are certified and licensed in the practice of audiology. Degree requires four years of full-time study beyond the bachelor's degree. Audiologists work with ENT Doctors and Audio Technicians to get a complete view of your audio health.


Audio Tech

According to the American Academy of Audiology, the minimum educational requirement for audiology technicians is generally a high school diploma. This could include on-the-job training or training through a formal educational program. 


Retail Sales Person

A degree is not required for any position. Sales people need a fantastic attitude, attentiveness and empathy for the client, and an ability to key in transactions to a computer, or through a kiosk. 

Are There Other Types of Hearing Devices I Should Consider?

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For people with the type of hearing loss that would benefit from OTC hearing aids, there are additional options you may consider:

  • A personal amplification device may be helpful and possibly less expensive than OTC hearing aids. These devices are typically a “boxy” receiver attached to headphones and are therefore bulkier than what you would expect from hearing aids. One example is a pocket talker.

  • Personal sound amplification products (PSAPs) amplify sound for the user but are intended for people with normal hearing to amplify sounds in certain situations, such as recreational activities like birdwatching, according to the FDA. PSAPs are regulated as consumer electronics and not medical devices.

  • Traditional prescription hearing aids from an ENT specialist or audiologist are a good choice if you are not getting the boost you would like from OTC hearing aids. OTC devices are not tuned to a hearing test, but prescription hearing aids are tuned to your exact level of hearing.

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