Due to the large number of hearing loss patients in the USA, FDA established a category of OTC hearing aids to further promote public health. FDA believes this measure will improve the benefits of deaf or hearing-impaired individuals, especially the old or debilitated. The policy is based on FDA’s Reauthorization Act of 2017 (FDARA), requirements for OTC hearing aids, including reasonable assurance of safety and effectiveness, and Federal preemption provisions. 

The new definition of OTC  hearing aids is as follows:
The device is provided to adults (over 18), and to those with hearing loss which is mild to moderate. Moreover, FDA gives several limits regarding the devices:

  1. 1. Output limits: The general limit will be 111 decibels of sound pressure level (dB SPL), with 117 dB SPL allowable for devices while input-controlled compression is activated.
  2. 2. Labeling limits: Allowing non-expert hearing aid users to understand.
  3. 3. Design limits: The device has volume controls to allow users to adjust as needed.
  4. 4. Quality system requirements: Required to match 21 CFR Part 820 compliance for medical devices.
  5. 5. Technical/Standard limit: Required to match ANSI/CTA-2051:2017.

In addition, FDA specified the difference between hearing aids and personal sound amplification products (PSAP). That is, hearing aids focus on assisting hearing loss patients [1], but PSAPs are not intended to aid or compensate for impaired hearing [2].

FDA is further planning the 510(k)-clearance requirements for the new OTC hearing aid category.




  1. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
  2. Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products