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OTC hearing aids


There are three main types of hearing devices in the U.S. – prescription hearing aids, over-the-counter (OTC) hearing aids, and personal sound amplification products (PSAPs). There are pros and cons to each, as shown in the comparison table below. In short, all three can amplify sound, but only the first two are specifically for people with hearing loss and allow for improving hearing of specific ranges of frequencies.

OTC hearing aids is the newest class of products. They are for people with mild to moderate hearing loss and are expected to be available starting in October 2022. They may be very similar to prescription hearing aids and are estimated to save the consumer over $2,800 per pair, largely because they are fitted and programmed (using an app) by the user, rather than by an audiologist. This savings is expected to make hearing aids more widely accessible, as many insurance policies, including Medicare, do not cover hearing aids, and those that do typically have deductibles, co-insurance, and/or co-payments.

Note that people with severe hearing loss who can neither hear nor discern conversation, as well as children and people who are cognitively impaired, should only consider prescription hearing aids. Also, it is best to be checked by a medical doctor before you decide on which type of hearing device to purchase, in order to rule out simple fixes (like earwax) or underlying medical issues that can be addressed, particularly if your hearing loss has come on recently, you’re having pain in your ear, hear ringing or buzzing, or you’re experiencing vertigo.

Hearing Aids & Devices Compared

Device Type and Cost



Prescription hearing aids

Appx. $1,000 - $14,000 per pair

Can boost sound more than a PSAP and have more targeted frequency-range boosts.

Fitted (including adjustments of frequencies) by professional audiologist

Regulated as a medical device regarding performance and manufacture.

Very expensive. Only available through an audiologist.

Over-the-counter (OTC) hearing aids

Expected on the market in October 2022

Expected to cost around $1,000 to $2,000 per pair

May work as well as prescription hearing aids.

No prescription.

Regulated as a medical device regarding performance and manufacture.

Not for severe hearing loss. Only for adults with mild to moderate hearing loss, suggested by:

- Trouble hearing in noisy places or on the phone

- Hard to follow speech in groups

- Listening makes you tired

- Need to turn up volume on TV or radio and others complain it’s too loud

Since self-fitted and programmed, may not be optimally adjusted and not appropriate for people with dementia.

Personal sound amplification products (PSAPs)

Typically several hundred dollars per pair



Amplify sound, and may include noise cancellation. Useful when listening to a lecture from a distant speaker or outdoors when birdwatching or hunting.

No prescription.

Relatively inexpensive.

May include noise cancellation.

Not regulated as a medical device, only as an electronic device.

Cannot amplify as much as prescription or OTC hearing aid (limited to 20 dB of gain). Amplifying broad ranges of sounds, rather than specific frequencies.

Not intended for people with hearing loss, but, in some situations, may work as well.

Sources: Federal Register Rule on OTC Hearing Aids (8/17/22); The New York Times Wirecutter (8/26/22); NPR (8/16/22).


As OTC hearing aids come to market, ConsumerLab will update this article with more product-specific information. In the interim, you may want to read a review of several existing products published by The New York Times Wirecutter (August 26, 2022).

PSAPs (personal sound amplification products)

It turns out that some PSAPs are just as good as a prescription hearing aid, while others are not, according to independent tests comparing the prescription hearing aid Oticon Nera 2 to the following PSAPs: Sound World Solutions CS50+, Soundhawk, Etymotic BEAN, Tweak Focus, and MSA 30X Sound Amplifier (Reed, JAMA 2017).

In the study, 42 older men and women (average age 72) with mild to moderate hearing loss were tested for hearing accuracy with no hearing device and with each of the PSAPs and the prescription hearing aid. Among the personal sound amplification products tested, the Sound World Solutions CS50+ and Soundhawk were the most effective, with the researchers finding just 1 and 1.8 percentage point reductions in accuracy, respectively, compared to the Oticon Nera 2 prescription hearing aid. Two of the other PSAPs were 4 to 7 percentage points lower than Oticon Nera 2 in hearing accuracy, and one, MSA 30X Sound Amplified PSAP, which cost only $30, came in much lower — just 65.3% accuracy — as shown below (as indicated in the table, some of the products in this study are no longer available).

Although there were some limitations to this study (i.e., the small number of participants and testing was conducted in a controlled environment, which may not represent all real-life auditory settings), the findings suggest that certain PSAPs offer a quality alternative to their costlier, prescription counterparts.

PSAPs Compared

Average Accuracy
Average difference in accuracy compared
to Oticon Nera 2 hearing aid
Oticon Nera 2 hearing aid
*Product no longer available on company website (6/30)
Sound World Solutions CS50+ PSAP
Soundhawk PSAP
*No longer available on company website; appears to be available from resell websites such as eBay
Etymotic BEAN PSAP
Tweak Focus PSAP
MSA 30X Sound Amplifier PSAP

Source: (Reed, JAMA 2017)

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