Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass) are pressing the Food and Drug Administration (FDA) over its “lack of action on writing rules to allow the sale of over-the-counter hearing aids,” the US Senate Committee on Finance announced on its website.

The Over-the-Counter Hearing Aid Act, a bill led by Grassley and Warren, was signed into law in 2017. That law allows the FDA to promulgate regulations categorizing certain hearing aids as “over-the-counter,” and sets an August 2020 deadline for such rules.

Last October, the FDA announced that writing those rules would be a priority for the agency, but “has shown no sign of progress since,” according to the announcement.

 “…although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars. For seniors or those on limited budgets, at these prices, hearing aids may not be obtainable,” the senators wrote. 

In a letter to the Acting FDA Commissioner, the senators requested a status update on the rules and an expected date for their finalization. The write:

“It is now December of 2019 and we have yet to see these regulations come to fruition. Given the ever increasing need for these devices, we request answers to the following questions by no later than December 19, 2019:

  1. What is the status of the OTC hearing aid rules and regulations?
  2. When do you expect to finalize the OTC hearing aid rules?”

Full text of the letter from Grassley and Warren can be found HERE. HR Editor Karl Strom reported in a recent blog that the proposed regulations would probably be delayed until at least Q1 2020.

Source: US Senate Committee on Finance