According to data from the National Center for Health Statistics, approximately 15% of American adults have hearing issues [1]. Fortunately, for those with mild or moderate hearing loss, there is now an affordable new type of over-the-counter (OTC) self-fitting hearing aid available, without the need for a prescription from a hearing healthcare professional. These non-prescription devices, developed by some well-known sound and hearing technology manufacturers, offer an opportunity for people to access the necessary hearing care at a more affordable price compared to traditional prescription hearing aids.


 Why are some hearing aids available without a prescription?

 Hearing loss significantly impacts the quality of life for tens of millions of adults in the United States, leading to high medical costs. Untreated hearing loss can result in isolation and is associated with serious conditions such as depression, anxiety, low self-esteem, dementia, mobility issues, and falls. However, only a quarter of adults with hearing loss have ever used hearing aids. Making hearing healthcare more accessible and affordable is a primary public health goal, especially with the continued growth of the elderly population in the United States.

The FDA's OTC Policy:

In 2017, the FDA Reauthorization Act empowered the U.S. Food and Drug Administration (FDA) to create a regulatory framework for over-the-counter (OTC) hearing aids. This was a significant development aimed at increasing accessibility and affordability of hearing aids for individuals with mild to moderate hearing loss.


Key points of the FDA's OTC hearing aid policy include:

 Creation of a New Category:

The FDA was directed to establish a new category of OTC hearing aids to make these devices more widely available without the need for a prescription.

Safety and Effectiveness Standards:

While the goal is to increase accessibility, the FDA maintains standards for safety and effectiveness. OTC hearing aids must adhere to specific criteria to ensure their safety and provide the expected benefits.

Consumer Education:

The FDA's approach not only involves making OTC hearing aids available but also emphasizes the importance of consumer education. Users are encouraged to understand their own hearing health, the functionality of the devices, and when it is appropriate to seek professional advice.

Collaboration with Audiologists:

The FDA encourages collaboration with audiologists and hearing healthcare professionals. Even with OTC options, individuals are advised to consult with these professionals to determine the most suitable solution for their specific hearing needs.

Implementation and Compliance:

The FDA is committed to implementing and enforcing these policies to ensure that OTC hearing aids in the market adhere to established standards.

OTC Hearing Aids: Who are they Suitable for?

OTC hearing aids are suitable for adults (18 years and older) who perceive themselves to have mild to moderate hearing loss, even if they have not undergone a hearing examination. If you experience the following, you may have mild to moderate hearing loss: 

  • Speech or other sounds seem muffled.
  • Difficulty hearing in a group, in noisy environments, on the phone, or when unable to see who is speaking.
  • Needing others to speak slower, louder, or repeat what they said.
  • Adjusting the volume of the TV, radio, or music higher than others prefer.
  • Difficulty hearing conversations in quiet environments or loud sounds, such as cars or trucks, noisy appliances, or loud music. These signs indicate potential hearing loss. Of course, you can seek advice and undergo a checkup from a professional ENT doctor!

Some ear problems require treatment. Seek prompt medical attention if you experience:

  • Discharge of fluid, pus, or blood from your ear in the past 6 months.
  • Ear pain or discomfort.
  • Excessive earwax or suspect an object in the ear canal.
  • Sudden dizziness (severe vertigo) accompanied by hearing loss.
  • Sudden onset of hearing loss or rapid deterioration.
  • Hearing loss worsened then improved in the past 6 months.
  • Hearing loss or ringing in only one ear, or significant difference in hearing between both ears.

If you are struggling with hearing loss, you now have more options: you can purchase hearing aids over the counter without dealing with the barriers associated with buying them through a doctor. Non-prescription hearing aids are relatively new, but there are already many choices available.

 Our company offers a variety of over-the-counter(OTC) hearing aids, including BTE hearing aids, ITC hearing aids and cic hearing aids styles. Each type of OTC hearing aid has differences in functionality and technology: some devices feature directional microphones, like the V402R from chosgo hearing, while others can directly stream music and phone calls to your hearing aids, such as the K23 product from chosgohearing. It is crucial to consider your lifestyle and prioritize which features are most important to you before making a purchase.

When purchasing the best OTC hearing aids, please consider the following factors: 

  • FDA Approval:

Ensure the hearing aid is FDA-approved. This ensures it meets certain safety and effectiveness standards.

  • Sound Quality:

Carefully consider sound quality, a crucial factor affecting the overall effectiveness of OTC hearing aids. Clear and accurate sound reproduction is vital for improving the auditory experience. Devices like SmartU from chosgohearing and eargo 7, utilizing advanced chips and expertise from audiology professionals, are recommended for their high sound quality.

  • User Reviews:

Look for reviews from other users to understand performance and user satisfaction.

  • Battery Life:

Battery life is another important consideration, directly impacting the convenience and overall effectiveness of OTC hearing aids. Consider your average waking, busy, or enhanced hearing time to determine the minimum required battery life. Some OTC hearing aids offer up to 12 hours of power, so if your activities extend beyond that, you may need devices with longer battery life.

  • Hearing Aid Styles:

Various styles are available in the OTC market, including traditional behind-the-ear, in-ear, and in-canal options. Choose based on your lifestyle and preferences.

  • App Connectivity:

OTC hearing aids are convenient, but the degree of dependence on applications should be considered. Many users value remote adjustments via smartphones, but if you prefer using device buttons for adjustments, choose devices that do not heavily rely on apps.

  • Price:

OTC hearing aids are generally more affordable than prescription ones. However, as a new market, insurance coverage may be limited. Prices vary, and financing options are available to make them more affordable.

  • Features:

Consider the features provided by the hearing aid, such as noise reduction, feedback suppression, and customizable settings.

  • Warranty and Support:

Warranty and support are crucial considerations for overall user experience and product reliability. A robust warranty provides a safety net, reflecting the manufacturer's confidence in the durability and performance of their product. Open and accessible support channels are vital for resolving challenges users may face during setup, usage, or maintenance.

  • Return Policy:

Check the return policy to ensure you can return the device if it does not meet your expectations. A trial period is essential, similar to trying out any product you purchase online. All products in our list offer a trial period.

About OTC Hearing Aids, Most Concerned Questions and Answers: 

  • How does insurance work with OTC hearing aids?

Your coverage depends on your plan, but many plans do not cover the cost of OTC hearing aids. The OTC market is still young, and it's currently unclear whether insurance companies will cover them in the future; this is still under consideration. Even without insurance, many companies offer monthly financing options, making OTC hearing aids more economically accessible.

  • Do I need to see a doctor to get OTC hearing aids?

You don't need to visit a doctor's office for a hearing assessment to purchase OTC hearing aids. However, if you have the means, visiting an audiologist to assess your needs, determine the degree of your hearing loss, and identify potential causes is still a good idea. 

  • Are non-prescription hearing aids as good as prescription ones?

A study published in the Journal of the American Medical Association Otolaryngology-Head & Neck Surgery found no significant difference in performance between OTC hearing aids and prescription ones. This suggests that seeing a doctor for fitting may not be absolutely necessary. However, OTC hearing aids are still a relatively new phenomenon, and more research is needed to comprehensively investigate performance differences based on hearing aid types and technologies.

When you get prescription hearing aids, they are fully customized to your preferences as you work with an audiologist to find them. For OTC, while many companies have robust online support, you largely rely on yourself. They may not completely substitute in-person assistance depending on your needs.