Dive Brief:
- The Food and Drug Administration’s final guidance on the regulatory requirements for hearing-aid devices and personal sound amplification products has taken a step toward publication. The guidance would create a new category of over-the-counter hearing aids, after Congress passed a law in 2017 requiring the FDA to allow for retail sales of the devices for adults with mild- to moderate-hearing loss.
- On Friday, the Office of Information and Regulatory Affairs completed its review of the guidance. The OIRA found the document to be consistent with the principles set out in an executive order on regulatory planning, while changes have been made since the FDA sent it for review.
- At this stage, the nature and extent of the changes are not known publicly. The FDA is under pressure from lawmakers who want it to swiftly sign off on retail sales of hearing aids.
Dive Insight:
The FDA submitted the guidance to the OIRA on July 8. Later that month, representatives of the OIRA, the FDA and other bodies met to discuss the regulatory requirements. The OIRA delivered its verdict on Aug. 5, less than 30 days after receiving the guidance. An executive order that sets out the role of the OIRA gives the office as many as 90 days to review regulations.
Few details on the review have been provided so far other than the guidance was coded as “consistent with change.” According to the Center for Effective Government, the term means “OIRA generally agreed with the intent of the rule, but made some substantive changes.”
The Government Accountability Office wrote in a report in 2003 that the term “does not indicate whether the changes made to agencies’ rules during the formal review process had been 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 to accuse manufacturers of hearing aids of running “astroturf campaigns.” The accusation was underpinned by an analysis that found 40% of the comments sent to the agency were form letters.
