OTC Hearing Devices

Lost, confused, unsure, or puzzled about the difference between prescription hearing devices and over the counter devices? We are here to help.

On October 17, 2022 over the counter devices (OTC) became available to the public. The bill making this possible was introduced in 2017 and finalized in August 2022. Since August, a lot of information has been circulating and it can be quite confusing. Here is what we think you should know:

For years, hearing aids (Class I & Class II FDA Medical Devices) were, and will continue to be, prescribed and professionally fit by audiologists and hearing instrument specialists based on information gathered during a full diagnostic hearing evaluation and listening needs assessment. The ruling that took effect on October 17th now allows some devices to be sold over the counter without the assistance of a licensed hearing healthcare professional. Based on the language in the ruling, OTC Devices ARE Recommended for Individuals who perceive a mild to moderate hearing loss that are over the age of 18.

OTC Devices ARE NOT Recommended for individuals:

  • With an asymmetric hearing loss (one ear hearing better than the other)
  • With a sudden change in hearing
  • Who have tinnitus – ringing, roaring, or other noise
  • Who have a history of chemotherapy and/or radiation to the head/neck
  • Who have active drainage from one or both ears
  • Who have ear pain or discomfort
  • Who have vertigo or imbalance issues

OTC devices may be a good first step for people who are just beginning to perceive a hearing loss. These devices will more than likely be appropriate for younger individuals (aged 40 – 65) who are fairly tech savvy and able to navigate the self-fitting process. However, for many this may not be a viable solution. Without a thorough audiologic evaluation, one may not know for certain that they need devices and more importantly, medical concerns could be missed and go untreated. We highly encourage anyone looking into assistance with their hearing first visit with a hearing healthcare professional for appropriate guidance. Freedom Hearing Center is dedicated to educating patients on their specific hearing thresholds and the options available to treat their hearing loss appropriately. Please use the image below for a quick reference regarding the two different types of devices now available.

For additional information on Over the Counter devices, check out the following articles: