FDA Approves Over-the-Counter (OTC) Hearing Aids

On August 16, 2022, the FDA approved the sale of Over-the-Counter (OTC) hearing aids. Starting from mid-October 2022, these hearing aids will be available online and in stores without requiring a prescription or a visit to a hearing specialist.

A doctor holds a chart.

What Does This Mean for You?

  • Accessibility: With OTC hearing aids, you can purchase them directly from stores or online, making them much more accessible for people with mild to moderate hearing loss. You no longer need to schedule appointments with audiologists or hearing specialists just to get a hearing aid.

  • Affordability: OTC hearing aids are expected to be more cost-effective. By eliminating the need for professional fittings and tests, you save on service fees and can find a device that fits your budget. This opens up hearing aid options to a wider audience who might have previously found traditional hearing aids too expensive.

  • Convenience: Purchasing OTC hearing aids will be as straightforward as buying any other over-the-counter product. You can shop at your own pace, compare different models and prices online, read reviews, and make an informed decision without the pressure of a sales pitch.
A picture shows Bluetooth hearing aids wearing.

Key Differences from Prescription Hearing Aids

  • No Professional Fitting Needed: Traditional hearing aids require a fitting by a licensed professional to ensure they work correctly and comfortably. In contrast, OTC hearing aids are designed to be simple and easy to use right out of the box, removing the need for professional assistance.

  • Self-Adjustable: OTC hearing aids are user-friendly and come with settings that you can adjust yourself. This allows for more personalized control over your hearing experience. You can fine-tune the device to meet your specific needs, experimenting with different settings in real-life situations until you find what works best for you.

  • Wider Availability: OTC hearing aids can be purchased from various retailers, both online and in physical stores. This wider availability means you can buy them from trusted brands and retailers you already know, making the process more comfortable and familiar. Additionally, the competitive market will likely drive innovation and improvements in hearing aid technology.
  • What Levels of Hearing Loss Can Be Treated with Over-the-Counter (OTC) Hearing Aids?

    The FDA restricts over-the-counter (OTC) hearing aids to be used only for self-perceived mild to moderate hearing loss. This is to protect users from the potential dangers of over-amplification, which can lead to permanent damage and more severe hearing loss. For all levels of hearing loss, from mild to severe, it is recommended to use prescription hearing aids fitted by licensed hearing professionals.

  • Are OTC Hearing Aids Suitable for Everyone?

    Hearing is vital to daily life, especially for the elderly. Regular monitoring of your hearing health is essential to catch any changes early, which can also help prevent dementia.
    OTC hearing aids are a new option available without a prescription. While they are great for many, they may not be suitable for everyone. If your hearing loss is due to a specific medical condition, it’s best to see a doctor for a hearing evaluation before purchasing an OTC hearing aid. This ensures you get the most appropriate device for your needs.

A picture show degree of sound in different environment.

How to Determine Your Level of Hearing Loss?

Hearing loss can vary in severity, ranging from mild, moderate, severe to profound. The degree of your hearing loss is determined by your ability to hear different tones (frequencies) at various volumes (decibels, dB).

Here are the common thresholds:

  • Mild Hearing Loss: 26 to 40 dB
  • Moderate Hearing Loss: 41 to 55 dB
  • Severe Hearing Loss: 71 to 90 dB
  • Profound Hearing Loss: Greater than 91 dB


You can assess your hearing level and choose the appropriate OTC hearing aid using the image provided.

The JIUYEE OTC hearing aids come with a built-in hearing test function that meets international audiometry standards. The test results are within ±10 dB of what you would get at a hospital. Your test results are automatically uploaded to the hearing aid’s chip, enabling the device to automatically adjust to your personalized hearing needs.

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