It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional (like an audiologist, otolaryngologist, or audiometrist).

[5] In the years leading up to the OTC Hearing Aid Act, the U.S. Institute of Medicine, U.S. National Academies of Science, Engineering and Medicine, President's Council of Advisors on Science and Technology, and U.S. Federal Trade Commission convened committees and workshops examining interventions to increase awareness of hearing loss as a public health problem, and improve access to acceptable, safe, and effective treatment options.

Regulations for the new class of hearing aid were originally supposed to be released by August 2020, but the FDA delayed them reportedly due to efforts focusing on COVID-19.

[2] The OTC Hearing Aid Act provisions were met with both support and concern regarding their effects on consumer safety, patient care, and hearing-related professions.

[20] Members of the public and hearing-related professional organizations expressed concerns over the prudence of creating a potentially sub-par class of devices in the absence of evidenced-based practices in patient-directed diagnosis and treatment.

[24] Critics also noted that in its current form, the Act omits support from licensed professionals, which has been found to improve patient satisfaction and product retention.