The FDA Reauthorization Act (H.R. 2430), recently signed into law by President Donald Trump, included the Over-the-Counter (OTC) Hearing Aid Act, which requires the Food and Drug Administration (FDA) to develop regulations within three years for hearing aids to be sold over-the-counter to individuals with mild to moderate hearing loss.
The Senate passed the legislation 94-1, over the objections of several industry associations, including the Hearing Industries Association, which argued that the legislation did not provide for “the devices [to] be safeguarded, the patient [to] be protected, and the hearing care professional [to] remain involved.”
The deregulation of the hearing aid market is likely to lead to a degradation of provider services, decreased product margins and an influx of new competitors in the hearing aid market.
More important, however, the new law may signal a willingness on the part of Congress to allow greater consumer self-determination in the selection and purchase of healthcare products and services, which could have a significant impact on bypassed providers. This trend bears watching by providers.