Who are OTC hearing aids for?

January 17, 2023

OTC hearing aids have been sold directly to customers since the middle of October. But questions remain as to what they are, who they would benefit from, and who would be advised to stick with regular prescription hearing aids. Let's try to clear some things up.

What is an OTC hearing aid?

As the name implies, over-the-counter hearing aids can be set up, calibrated, and changed by the user and are offered directly by manufacturers and on medical websites (that is, no in-person doctor or audiologist visits are required).

Personal sound amplification products (PSAPs), a subpar class of amplifying equipment you may buy without a prescription or seeing a healthcare provider, should not be confused with over-the-counter (OTC) hearing aids. PSAPs are not regulated as medical devices by the FDA, but the FDA regulates OTC hearing aids as medical devices for people with hearing loss.

OTC hearing aids will vary from OTC hearing aids in the following ways:

  • They'll be cheaper
  • They won't require a hearing test to buy
  • They will likely lack cutting-edge hearing aid features like activity tracking and artificial intelligence.
  • They will only be suitable for those with mild to moderate hearing loss.


The new OTC hearing aids category has garnered much interest, but the ruling is still divisive. The purchase and use of over-the-counter hearing aids by consumers without first undergoing a hearing examination done by a hearing health specialist concerns certain members of hearing health industry groups. They are concerned that consumers may have ear damage from excessive amplification or be unsatisfied with the device's performance and stop using hearing aids entirely, which might have severe social and medical repercussions.

Who would benefit from an OTC hearing aid?

Those with mild-moderate hearing loss.

If your hearing loss isn't too severe and you don't have any health conditions that may complicate things, OTC hearing aids can be a smart solution.

Here are a few signs that you may have mild to moderate hearing loss:

  • Syllables and high-frequency consonants go unheard. For instance, you might hear the word 'cat' instead of 'sat.'
  • You regularly ask others to repeat themselves.
  • When someone whispers to you, such as in a movie theater or auditorium, it's difficult for you to understand what they're saying.
  • You've begun to change your behavior in public, such as moving closer to the lecturer during each week's session or requesting that your spouse stop speaking to you in another room since you can't hear them.

Those who value convenience highly.

OTC hearing aids can be obtained without the hassle and cost of obtaining a prescription from a physician or audiologist. Going the over-the-counter route is an excellent option if you don't have many providers nearby or can't quickly get to and from an audiology office.

Those on a limited budget.

The cost of OTC hearing aids will be lower than prescription hearing aids. Because of cost concerns, they appeal to individuals who have been hesitant to treat hearing loss.

Cons of OTC hearing aids

Children, those with profound or severe hearing loss, those unable to communicate or make medical decisions on their own, and those whose needs cannot be met by OTC hearing aids should consider prescription hearing aids.

Consult a hearing health professional if you have trouble hearing conversations in quiet environments or if you have difficulty hearing loud noises, such as those made by cars or trucks, noisy appliances, or loud music. These are indications that your hearing loss may be more severe and that over-the-counter hearing aids won't be effective for you.

If a prescription hearing aid or another device can improve your hearing, a hearing health professional can assist you in making that determination.

OTC hearing aids can also not identify or address the underlying cause of hearing loss. You must visit an audiologist for that.

OTCs may be less expensive, but this comes with a lack of additional assistance, such as professional setup or maintenance of the hearing aid. This is significant because the success of using hearing aids often depends on the professional fitting of the device as well as routine follow-up visits to the hearing specialist for adjustments and guidance.

OTC hearing aids may be beneficial in the short term, but they may only discourage users from seeking medical attention for their hearing loss.

The arrival of OTC hearing aids into the market is excellent news for people with hearing loss, but not everyone should use them. To find out whether an OTC or prescription hearing aid would best meet your needs, schedule an appointment with us today!

Written by
Reviewed by
Dr. Emma Durazzo
Owner & Doctor of Audiology
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With years of experience and continued professional training, Emma Durazzo (formerly Emma McCue) has developed her expertise in a variety of subspecialties within the scope of audiology.