BTE Hearing Aids and 'FDA'


Type 'hearing aid' and your page is filled with products claiming to be the best for you, the most advanced...along with mentions of 'FDA'. Terms like smart technology, hearable, hearing technology, AI, OTC, all claiming to hep you hear better, are plentiful. So are the invites for easy, quick, online hearing tests that determine the perfect matching hearing aid for you. So what is the FDA oversight and what does it mean for your product quality and its ability to meet your day-to-day needs?


Here are some quick takes and resources for you to help decide for yourself

I. Regulations - simplified


Hearing Aids*

  • Medical devices as they are intended to treat hearing loss and are under FDA purview

  • Different levels of FDA review for performance, safety and effectiveness depending on the technology

  • Code of Federal Regulations (CFR) dictate product requirements that need to be followed by manufacturers and FDA

Common CFRs relevant to your Hearing Aids

  1. Digital (air conduction) Hearing Aids (i.e. most BTEs) 21CFR874.3300 : No FDA submission - but manufacturers need to perform performance (e.g. electroacoustic) and safety testing and follow basic 'controls' such as good manufacturing practice, no false advertising, monitor safety and complaints, recordkeeping, repair, replacement, refund provisions

  2. Digital, Wireless Hearing Aids 21CFR874.3305 : No FDA submission - but manufacturers need to perform additional testing and follow more controls such as additional safety testing, wireless technology testing, providing detailed instructions and safety information to the user

  3. Digital, Wireless, Self-fitting Hearing Aids 21CFR874.3325 : Requires FDA submission and review - and manufacturers need to perform further testing and follow additional controls such as clinical testing, more safety and usability testing, more detailed instructions to the user

Note: FDA is working on the OTC Rule; there are no OTC Hearing Aids meeting FDA standards until Rule finalization. Also claims of 'AI' with respect to Hearing Aid functioning need to be reviewed and authorized the FDA.


PSAPs: Personal Sound Amplification Product

  • Not a medical device as it is intended for persons with normal hearing

  • No FDA review and not registered or listed in FDA database

  • Manufacturers do not follow hearing aid controls

Note: PSAPs are frequently marketed with descriptions other than 'hearing aids' but with features suggesting use by those with hearing loss


Hearing Tests*:

  • Medical devices as they are intended to diagnose hearing loss and other otologic disorders and are under FDA purview

  • Audiometer 21CFR874.3305 : No FDA submission - but devices consist of calibrated earphones and software application for testing accuracy based on World Health organization (WHO) guidelines for hearing loss and safety; need to follow basic controls