The 411 on OTCs

According to the CDC (Centers for Disease Control), there are 40 million adults with documented hearing loss in this country.  Out of that population, only 30% (70 years of age or older) are using hearing aids.  That percentage drops to only 16% of those 20-69 years of age.  If hearing loss is so prevalent, then why are so few people treating it?  Studies have shown that untreated hearing loss can significantly impact one’s quality of life.  It has been associated with other health conditions such as depression, anxiety, dementia and an increased risk for falls.  It stands to reason that with all of these associated healthcare risks raising the overall healthcare costs for a consumer, making hearing aids more accessible and affordable should be a priority.

10/17/23 The 411 on OTCs


Hearing aids were first introduced at the turn of the century and became common-place in the 1920s.  Their technology rapidly evolved from transistor-style, to microprocessors, to microcomputers and digital sound processing.  All the while, they’ve been trying to make hearing aids smaller, faster and clearer with improved battery life and connectivity to modern electronic devices.   

Hearing aids aren’t just ‘amplifiers’.  They are actual medical devices.  They are intended to treat hearing loss and can be worn either behind or inside the ear.  Hearing aids do not restore hearing to normal levels.  The FDA (Food & Drug Administration) regulates all hearing aids to ensure safety and effectiveness for consumers.  They also ensure that companies who manufacture and sell hearing aids comply with good manufacturing practices.  Selecting a hearing aid is not a simple decision.  Hearing loss is as unique as the individual who has it.  It is important to choose a device that is not only appropriate for your hearing level, but one that is also appropriate for your  lifestyle and personal preferences.    


In October 2022, the FDA established a new category of hearing aids with the hopes of increasing public access to hearing aid technology and improving the affordability of hearing aids for the general public.  This new category would be known as “OTC (over-the-counter) hearing aids”.  It is intended for adults (18 and over) with perceived mild-to-moderate hearing loss.  Before this time, hearing aids were only dispensed by medical professionals in a clinical setting.  With OTCs, the consumer can now choose to pursue hearing aids without visiting a medical office and they have control of the hearing aids themselves, either via an on-board volume control or a mobile app on their smartphone.  OTCs are truly intended for users with mild to moderate hearing loss.  If a user has a severe to profound hearing loss, it is recommended that they consult with a licensed hearing health care provider because OTC hearing aids are not able to provide adequate benefit for those levels of hearing impairment.  OTCs are not a replacement for traditional, prescriptive hearing aids, but are an alternative to them, for the proper candidate.  Both prescriptive and OTC hearing aids help users to be better able to listen, communicate and participate in daily activities.  It takes time and practice to get used to hearing aids.  No matter what option you pursue, you should wear them regularly to become familiar with them and to train the brain to hear through amplification.          


You may have seen some products advertised as ‘amplifiers’.  These are also known as PSAPs (personal sound amplification products).  They are not hearing aids.  They are intended for people without documented hearing loss.  They help boost the user’s ability to hear in certain situations (like bird-watching, or TV-viewing), but are not hearing aids.  They are not FDA-regulated and are not intended to treat hearing loss.  Wearables are a body-worn computer, generally used for entertainment purposes.



OTC Hearing Aids

Prescriptive Aids



Type of Product

-Medical device

-Electronic device

-Medical device

-Electronic device

-Electronic device

-Electronic device

Intended User

-At least 18 yrs of age

-Mild to moderate HL

-All Ages

-Any degree of HL

-Normal Hearing



-No doctor visit or prescription required


(via onboard volume or mobile app)

-Healthcare provider ‘assistance’ available


-Prescription Fit

-Healthcare Provider treats the hearing loss

-All-inclusive hearing healthcare approach

-Not intended for treating underlying hearing loss

-Improve hearing in specific situations (hunting, TV-viewing, lectures, etc.)

-Body-worn computer

-Improve hearing for entertainment purposes (ie: AppleAirPods)

FDA regulated





Selfcare vs. Healthcare Provided


(adequate tech-savviness)


-Healthcare Provider (professional treatment)




Decision-making in regards to your healthcare should not be taken lightly.  Do your due diligence.  Research and trust your instincts.  Ensure you have the proper information in regards to what is and to what is not an actual hearing aid.  Before you pursue OTCs, ensure you are an ideal candidate.  When in doubt, visit your local hearing healthcare provider for guidance.  But ultimately, do not put off treating your underlying hearing loss.  There are many options available to ensure you are living your best life and not missing out on a thing.


Jalene Nadeau, AuD
With close to two decades of experience in ENT offices, Jalene brings invaluable expertise in audiology. Graduating with distinction in Audiology from the University of Connecticut in 2002, she has been a pioneer in the evolving field of hearing health. Jalene's dedication to staying at the forefront of modern technology has enabled her to revolutionize the remote experience of enhanced hearing for clients.
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