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OTC Hearing Aids:
What You Need to Know

Are OTC hearing aids for you? CHC can help.

On August 16, 2022, the FDA issued their final rule regarding the sale of over-the-counter (OTC) hearing aids which are a new class of lower-priced, self-fit hearing aids.


The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Those with greater than this degree of hearing loss or children under the age of 18 years of age are not included in these new regulations and would still purchase prescription hearing aids with the support of an audiologist.


The effective date for the final rule following this announcement is in 60 days and so we anticipate that by mid-to-late October, OTC hearing aids will be available through pharmacies, big box stores, online and perhaps at CHC.


At CHC, we are here to guide our clients in identifying the best type of hearing device for them. Currently, there are a wide range of options, from assistive hearing devices to traditional amplification. OTC hearing aids may prove to be a viable new option for some.  

There is still a great deal not known about the regulations for OTC hearing aids. At this time, this is what we do and do not know.

OTC Hearing Aids Basics


  • OTC hearing aids are only for adults age 18 and older who have a perceived mild-to-moderate hearing loss

  • They may not be purchased for children

  • They will not help anyone with greater than a moderate hearing loss

  • They are not expected to be covered by insurance, but this is a big unknown

Role of Hearing Testing


The FDA guidelines do not require that a hearing test be conducted prior to purchasing an OTC hearing aid. However, we do not believe that an appropriate recommendation for amplification can ever be made without the completion of a full hearing test; without a hearing test, we cannot determine if you have a hearing loss that could be helped with OTC hearing aids. 

Therefore, at CHC we will not make a recommendation for any type of amplification or help to program a device without a hearing test. Your hearing test can either be done here at CHC or elsewhere by another licensed audiologist and then submitted to CHC. As part of any hearing test, we will always partner with you and help you find the best technology solution that's right for you. Shortly, that may include OTC options.

OTC Hearing Aids Setup and Adjustments

OTC hearing aids are designed to be purchased, programmed, and adjusted on your own without the support from a hearing care professional. We expect many OTC hearing aids will require use of a smartphone. 

We know that many individuals may desire help from an audiologist to program and adjust an OTC hearing aid purchased. So we're prepared to provide support. Once OTC hearing aids are available for sale, check back with us to learn about the different ways we can help.


Address Your Hearing Needs Promptly

If you have concerns about your hearing, we recommend not waiting until OTC hearing aids launch. A CHC clinician can help you with determining the best solution to help you get back to enjoying all the things you love. Reach out to us and set up a time with a CHC audiologist. Or, as a first step, try our online hearing screening tool.

For more information about CHC, hearing health topics and more, sign up for our e-newsletter

The Buzz. And be sure to check out our other content on OTC hearing aids.

CHC's Comments to FDA on OTC Hearing Aid Draft Regulations (Jan '22)

OTC Hearing Aids: What You Need to Know (Dec '21)

OTC Hearing Aids: FAQs (Jan '22)