fda otc hearing aid rule

Senator’s Investigative Report Alleges Major Hearing Aid Companies ‘Efforts to Undermine’ OTC Hearing Aid Regulations

WASHINGTON, D.C. – U.S. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) released the findings of their new bipartisan investigative report: Loud and Clear: Why Americans Want Effective and Affordable Over-the-Counter Hearing Aids – and How Powerful Special Interests are Trying to Undermine Them. 

According to the news release from the senators, the report details dominant hearing aid manufacturers’ efforts “to undermine” the Food and Drug Administration’s (FDA) proposed rule for Establishing Over-the-Counter Hearing Aids and “diminish the effectiveness of over-the-counter (OTC) hearing aids”.

The senators sent a copy of their new report and highlighted its key findings in a letter to Robert Califf, Commissioner of the FDA, and called on the FDA to review their findings and adopt a final rule that promotes competition, reduces prices, and meets high standards of safety and effectiveness. 

“Our bipartisan investigation reveals that powerful stakeholders, including dominant manufacturers in the highly-concentrated hearing aid industry, are using astroturf lobbying tactics to weaken the FDA’s proposed rule, harming American consumers. We support the FDA’s proposed rule, which will expand access, reduce costs, and ensure a robust new market for safe and effective OTC hearing aids – and urge the FDA to finalize a robust rule that is consistent with the intent of our Over-the-Counter Hearing Aid Act 

–Sen. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) 

In 2017, the Over-the-Counter Hearing Aid Act, introduced by Senators Warren and Grassley, was signed into law. The legislation’s goal was to “remove outdated regulations that block consumer access to hearing aids and allows certain types of hearing aids to be made available over-the-counter”.

The FDA was responsible for implementing this law, and in October 2021, it issued a proposed rule for “Establishing Over-the-Counter Hearing Aids.”

Over the course of a 90-day public comment period. FDA received approximately 1,100 comments on the proposed rule. To understand the public’s response, the senators conducted a comprehensive review of these comments. 

Findings from the report:

  • Americans Believe OTC Hearing Aids Will Have Significant Benefits: Nearly 38 million Americans experience hearing loss, “yet because of high costs only one in five people who would benefit from a hearing aid use one”. In the public comments, Americans shared their personal stories and explained what accessible, affordable, safe, and effective OTC hearing aids would mean to them and their loved ones.
  • Key Health Care Professional Groups Support FDA’s Proposed Rule: Many comments submitted by health care professionals, including the Academy of Doctors of Audiology, indicated support for the proposed rule and affirmed that it would allow for safe and effective OTC hearing aids.
  • Dominant Hearing Aid Manufacturers Are Seeking to Weaken FDA’s Proposed Rule: The “Big Five” hearing aid manufacturers control more than 90 percent of the highly-concentrated market, which is a contributor to the high price of hearing aids. According to the senators, “these dominant hearing aid manufacturers benefit from the status quo and oppose key provisions of the FDA’s proposed rule.”
  • Dominant Hearing Aid Manufacturers and Aligned Groups Backed ‘Astroturf Campaigns’ to Weaken FDA’s Proposed Rule and ‘Distort Public Perception’: According to the senators, stakeholders “benefiting from the status quo launched letter-writing campaigns that generated over 400 comments, nearly 40 percent of all publicly available comments that the FDA received, which – in whole or in part – appeared to be form letters rather than the independent views of those who sent them.”

The senators are calling on the FDA to review the findings of their report when analyzing the public comments and to finalize a rule that ensures safe, effective, accessible, and affordable OTC hearing aids. 

Since the senators’ legislation was signed into law, they have been leading the effort to implement the legislation and “create an affordable and effective OTC hearing aid market”.

In April 2022, Senators Warren and Grassley introduced new legislation that would require the FDA to issue a final rule regarding OTC hearing aids within 30 days of the enactment of the bill. 

**Read the full report here.

**Read the letter sent to FDA commissioner Califf here.

 

Source: Office of Sen. Warren 


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