OTC 101: Personal Sound Amplification Products (PSAPs) vs. Over-the-Counter Hearing Aids

What is a Personal Sound Amplification Product (PSAP)?

A Personal Sound Amplification Product, also known as a PSAP, is a wearable device that is used to amplify sounds. It is not considered a hearing aid.

One of the most important things to note about PSAPs is that these devices are intended for use by individuals who do not have hearing loss. For this reason, PSAPs do not require a prescription to purchase. PSAPs lack the more sophisticated technology found in OTC (Over-the Counter) hearing aids. PSAPs do not have directional microphones, noise management strategies, or other advanced features found in hearing aids.

Another key difference between PSAPs and OTC hearing aids is seen in how they are regulated. PSAPs are regulated as electronic devices by the FDA, not as medical devices. OTC hearing aids are regulated as medical devices by the FDA. PSAPs could be easily confused for OTC hearing aids, so it is important to check that the device you are purchasing is correct for your intended use.



What is an Over-the-Counter (OTC) Hearing Aid?

In 2022, the FDA established a new category of OTC hearing aids. This expanded the category as well as access to these medical devices for those with mild-to-moderate hearing loss.

An over-the-counter (OTC) hearing aid is a hearing aid intended for use by those who have mild-to-moderate hearing loss and are over the age of 18. OTC hearing aids do not require a prescription, which makes them convenient to purchase and use for those with mild-to-moderate hearing loss. OTC hearing aids can be purchased directly from the hearing aid brand or from a retailer that sells OTC hearing aids.

There are a couple of different types of OTC hearing aids: non-self-fitting, and self-fitting. For more in-depth information about each of these types of OTC hearing aids, check out this article. OTC 101: Self-Fitting vs. Non-Self-Fitting OTC Hearing Aids

Concha Labs’s OTC hearing aids are considered self-fitting. Self-fitting means that the user will adjust and fine-tune their hearing aid settings on their iPhone on their own. This allows users to get the hearing help they need without an audiologist appointment. Different self-fitting OTC hearing aids use different fitting technology, and not all OTC hearing aids are self-fitting. To learn more about the self-fitting technology used by Concha Labs, check out our Soundscope® page.

If You Have Hearing Loss, Should You Try a PSAP or an OTC Hearing Aid?

As previously mentioned, PSAPs are not intended for use by individuals with hearing loss. The technology used in a PSAP is not as sophisticated as the technology used in an OTC hearing aid. PSAPs will only amplify all environmental sounds. For those with hearing loss, a PSAP will not help you hear more clearly, it will only increase the volume of all sounds including background noise. A PSAP might work for you if you don't have hearing loss but want to amplify your hearing for situations such as hiking or bird watching.

If you have mild-to-moderate hearing loss, an OTC hearing aid could be a solution for you. If you want to learn more about how Concha Sol hearing aids could help you with your mild-to-moderate hearing loss, check out our Product page.
https://conchalabs.com/products/concha-sol-hearing-aids