What's The Difference? - PSAP vs OTC vs RX

What's The Difference? - PSAP vs OTC vs RX

So you've decided (or someone told you!) that you need hearing aids. You soon found yourself online - shopping around - becoming more and more confused. You've found out-of-date info and new classifications of devices as well as descriptions of products that contain medical terminology and all kinds of acronyms... you can quickly become lost in a task that did not originally seem daunting. Let's break down the 3 main categories of electronic hearing devices and what exactly they mean!

PSAP - Personal Sound Amplification Products

Let's start with the simplest and somewhat misleading category of products right off the bat. PSAP or personal sound amplification products are not hearing aids in the traditional sense of the term. While they do technically "aid in hearing" they are not medical devices. You can think of these as devices to augment the hearing of a person above what is considered "normal." These devices are often used by birdwatchers or hunters in order to better hear the creatures and critters they are searching for. You may also see directional microphones hooked up to headphones at sporting events... or in spy movies. These are PSAP's and are not intended to alleviate any level of hearing loss.


RX - Prescription Hearing Aids

Moving on to the more traditional hearing aids that you've seen for ages. There are many different types of hearing aids for different levels of hearing loss. They come in various shapes and sizes with varying levels of features. At the end of the day, they all require a trip to a medical professional to have a test done and a prescription before they can be purchased. Up until recently, all hearing aids fell into this classification from the FDA. 


OTC - Over-the-Counter Hearing Aids

In the fall of 2022 (read more about the introduction of the OTC option here), the FDA ruled that mild to moderate hearing loss could be alleviated without the intervention of a medical professional. Technology within the hearing aid market has advanced far enough that mild to moderate hearing loss in many - though certainly not all - people can be corrected by a product that allows for a basic hearing test on a mobile device (often called "self-fit"). The results from the test that you can take from the comfort of a quiet room in your own home are then wirelessly loaded onto the OTC hearing aid and a profile is created for that user's unique hearing.


 For the visual learners among us, here's a helpful table describing the differences between these devices courtesy of the FDA.

OTC RX PSAP
Stands For Over-the-Counter Prescription Personal Sound Amplification Products
Product Classification Medical device Medical device Consumer Electronic
Age Range 18 and older Any age Any age
Intended User(s) People with perceived mild to moderate hearing loss People with any degree of hearing loss, including severe People with normal hearing to amplify sounds in certain environments
Conditions for Sale
  • User must be 18 years old
  • No medical exam
  • No prescription
  • No fitting by audiologist
  • No need for licensed seller
  • Prescription needed
  • Must purchase from licensed seller in most states
  • Fitting and follow up(s) with medical professional often required
Not intended to correct hearing loss; no applicable FDA requirements regarding the sale and use

 

Back to blog