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What Are OTC Hearing Aids?

Updated: Nov 10, 2022

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Over-the-counter (OTC) hearing aids are devices that make sounds louder.

OTC hearing aids:

  • Are approved for adults 18 years of age and older

  • Are indicated for individuals with mild to moderate hearing loss

  • Are available in stores or online and the consumer is responsible for setting up the device, including fitting and tuning the sound

  • Do not require a hearing exam or prescription from a physician or a hearing-health-care professional

Although not required, any consumer can get a hearing test from an audiologist before buying OTC hearing aids. The key benefit is finding out if an OTC hearing aid device can be useful for the consumer’s hearing loss. Not all hearing loss is the same. Through an office visit (which is usually not covered by insurance), the audiologist also can provide support on how to use the OTC hearing aids.

OTC hearing aids are meant to be less expensive than professionally fitted hearing aids. Reasons for lower cost include technology differences and buying only the device and not any professional services. Current estimates are that OTC hearing aids will cost between $300 and $600 per device.

Why Are Hearing Aids Being Offered Over the Counter?

The Food and Drug Administration (FDA) Reauthorization Act of 2017 directed the FDA to establish and develop regulations for a class of OTC hearing aids in response to demands by consumers and other government agencies for affordable and accessible hearing aids in the United States. The FDA is in the process of finalizing regulations that will apply to this new class of amplification devices. These rules will include the following:

  1. How loud these devices can be,

  2. What labeling will be required on the outside and inside of the box that these devices come in, and

  3. What requirements are related to the sale of these devices.

What is the benefit of having OTC hearing aids available? Studies show that the average person waits 7–10 years after first experiencing symptoms before seeking professional hearing help. Studies also link untreated hearing loss with an increased risk of depression, falls, and earlier onset of decline in thought processes. One goal of OTC hearing aids is to provide more timely access to lower-cost hearing aids.

OTC hearing aids may be a good first step in getting people situational hearing help earlier; however, when individuals need a more customized solution, have complex medical needs (e.g., difficulty using hands or problems with thought processes), or have an increasing degree of hearing loss, they need to involve an audiologist to create a comprehensive plan of care.

Who Is a Good Candidate for OTC Hearing Aids?

OTC hearing aids are approved for use only in adults 18 years of age and older who have mild to moderate hearing loss.

It is advised that individuals receive a hearing test from an audiologist to find out the level of hearing loss and know that they are candidates for this type of hearing aid. However, because a hearing test is not required, individuals could instead consider the following questions to identify mild to moderate hearing loss:

  1. Are you able to hear easily in quiet, one-on-one situations?

  2. Are there a few difficult listening situations where you think you would want to wear the OTC hearing aids as opposed to feeling like you would need it in most communication situations?

  3. Does turning up the volume on the phone or TV just slightly help you hear better (this level might be considered a little loud by others but not extremely loud as opposed to needing to turn these devices up quite a bit to a level that bothers others)?

If you answered yes to these questions, you may have mild to moderate hearing loss. People with more severe hearing loss have difficulty in these situations as well, but they have difficulty more consistently across many situations as identified by themselves or by those around them.

OTC hearing aids require that the user can follow instructions to fit the device to their ear and tune the sound of the device. An automated hearing test that requires responses to sounds may be offered. The process also could include managing a volume control or app-based program that has the user change the bass (low pitches) and treble (high pitches) to find a sound combination that seems to be helpful.

Can Children Use OTC Hearing Aids?

No. OTC hearing aids are approved only for individuals 18 years of age and older. Due to the medical nature of childhood hearing loss and the importance of accurate sound delivery for the developing brain, OTC hearing aids are not appropriate for children.

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