How do over-the-counter (OTC) hearing aids compare to prescription hearing aids?

Answer:

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.

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.

OTC Hearing Aids

OTC hearing aids is the newest class of products. They are for people with mild to moderate hearing loss and first became available in the U.S. in October 2022. They 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.

There is evidence that self-fitted OTC hearing aids may be similar in effectiveness to the same hearing aid that is fitted by an audiologist for people with mild to moderate hearing loss. A study in South Africa among 64 people (average age 64) with self-reported mild to moderate hearing loss showed that those who used a self-fitted OTC hearing aid (Lexie Lumen by Lexie Hearing) for 6 weeks reported similar hearing aid benefit and speech-in-noise benefit (i.e., the ability to hear spoken words when background noise is present) as those who received the same hearing aid fitted by an audiologist who also fine-tuned it after the first 2 weeks. Those given the OTC hearing aid were provided with instructional material to help set up the device using the Lexie app and the option to contact remote support for adjustments or troubleshooting after the first 2 weeks (De Sousa, JAMA Otolaryngol Head Neck Surg 2023). Follow up with participants in this study 8 months after the initial fitting continued to show no significance difference between the groups in terms of overall hearing aid benefit, and the self-fitted group gave slightly higher scores than the audiologist-fitted group on satisfaction with the device (De Sousa, JAMA Otolaryngol Head Neck Surg 2024).

As more OTC hearing aids are investigated in clinical research, ConsumerLab will update this article with more product-specific information, including how the products compare to prescription devices. In the interim, you may want to read reviews of several existing products published by The New York Times Wirecutter (Updated September 17, 2025) or Consumer Reports (Updated March 16, 2025).

If you're considering an app-based hearing aid, be sure the app is compatible with your mobile device, e.g., some only work on iPhones.

Be aware that people with the following conditions should see a healthcare professional such as an ear-nose-throat doctor before getting an OTC hearing aid, as an OTC device may not be the best option for these individuals (FDA, 5-3-23):

• Difficulty hearing even if the room is quiet
• Difficulty hearing loud sounds
• Ear has a birth defect, unusual shape, or was injured or deformed in an accident
• Blood, pus, or fluid has come out of the ear within the last 6 months
• Ear feels painful
• Having ear wax or feeling like something is in the ear
• Dizziness or feeling a spinning (vertigo)
• Hearing changed suddenly within the last 6 months
• Hearing gets worse then gets better
• Hearing loss is worse in one ear
• Ringing or buzzing is heard in only one ear

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). (Note: Many of the PSAPs tested in this study are no longer available as of July 11, 2024).

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 significantly less than other PSAP devices, came in much lower — just 65.3% accuracy.

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.