FDA hearing aid guidelines allow regulatory review amid pressure from lawmakers for over-the-counter sales


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Diving Brief:

  • The Food and Drug Administration’s final guidance on regulatory requirements for hearing aids and personal sound amplification products has taken a step towards publication. The guidelines would create a new category of over-the-counter hearing aids, after Congress passed a law in 2017 requiring the FDA to allow the devices to be sold at retail for adults with mild to moderate hearing loss.
  • On Friday, the Office of Information and Regulatory Affairs finished his exam guidance. The OIRA found the document consistent with the principles set out in a regulatory planning executive order, while changes have been made since the FDA sent it for review.
  • At this stage, the nature and extent of the changes are not publicly known. The FDA is under pressure lawmakers who want him to quickly approve retail sales of hearing aids.

Overview of the dive:

The FDA submitted the guidelines to OIRA on July 8. Later that month, representatives from OIRA, the FDA and other agencies met to discuss regulatory requirements. OIRA issued its verdict on August 5, less than 30 days after receiving the advice. An executive decree that defines the role of the OIRA give the office up to 90 days to review settlements.

Few details of the review have been provided so far other than that the guidelines have been coded as “compatible with change”. According to the Center for Effective Government, the term means “OIRA generally agreed with the intent of the rule, but made some substantial changes.”

The Government Accountability Office wrote in a report in 2003 that the term “does not indicate whether changes made to the agencies’ rules during the formal review process were suggested by OIRA or the agencies, or whether the changes were substantive or editorial in nature.”

The FDA proposed the creation of a new category of over-the-counter hearing aids in October. Earlier this year, Senators Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa wrote to the agency accusing hearing device manufacturers of running “astroturf campaigns.” The accusation was supported by an analysis which found that 40% of the comments sent to the agency were form letters.


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