Medical Devices for Hearing-related Conditions:

Know what is Safe and Effective

This report was prepared in observance of the

Federal Trade Commission's

 NATIONAL CONSUMER PROTECTION WEEK

March 2022

 

Advertisements on social media, TV, print, streaming services, frequently promise quick and easy access to products which claim to test, treat, prevent hearing-related medical conditions

Some product examples:

  • Online hearing tests

  • Tinnitus treatments

  • Hearing Aids that are available ‘over-the-counter’

  • Hearing Aids claiming other functions like improved balance, fall prevention, preventing memory loss

 

Hearing loss is a medical condition and associated products are ‘medical devices’, that under the purview of the Food and Drug Administration (FDA) - Division of Ear/Nose/Throat devices

  • Reviewers have extensive device knowledge and have specified standards and testing for your safety and effectiveness

  • All products, with hearing-related claims, need to meet these standards

  • In addition, some of the products are reviewed by the FDA per current regulations

  • If reviewed, the products can claim to be ‘FDA approved’, ‘FDA cleared’, or ‘FDA authorized’

 

All medical products need to be Registered and Listed in the FDA database prior to sale - this does NOT mean FDA has reviewed all products for their claims  

You may have seen words like this with a hearing aid promotion:

  • FDA Registered

  • FDA Listed

  • FDA Certified

  • FDA Registration Certificate

  • Medical Grade

  • Premium

These are deliberately misleading to lead you to think that the FDA has reviewed these hearing aids for their safety and efficacy claims - when they have not been. Thus, they may or may not meet FDA standards to support their claims.

In addition, several products have claims such as treating tinnitus, which require FDA review - but the products may have not been submitted to the FDA!

CHECK if your product has been reviewed by the FDA.  

 

False or misleading promotions are a violation of the law

Federal organizations such as the Federal Trade Commission (FTC) and the FDA monitor and take action against businesses selling fraudulent products that often provide limited benefit but can cause serious harm.

 

You can help to fight fraud

 

1-877-FTC-HELP

ONLINE

 

 

EMAIL

ONLINE,

If you have been hurt: REPORT

 

 

 At Audition Technology, we engage with the FDA early and consistently throughout product development to meet  standards to support our claims.