Lawmakers urge President Biden to Adopt Consensus Recommendations on OTC Hearing Aids

A group of Democratic lawmakers penned a letter to President Joe Biden urging the administration to consider the consensus recommendations from several leading hearing care associations to prioritize over-the-counter (OTC) hearing aid safety and effectiveness.

The letter — spearheaded by Reps. Betty McCollum (D-MN), Rosa DeLauro (D-CT), Jan Schakowsky (D-IN), Lucile Roybal-Allard (D-CA), and Andre Carson (D-IN) — noted that devices that are currently marketed as OTC hearing aids are "nothing more than cheap amplification devices that can further damage the user's hearing." It also cites that bipartisan attorneys general from across the country and political spectrum have issued warnings about the risks of unapproved personal amplification devices that can further damage a patient's hearing. 

With respect to policy solutions, the Democratic lawmakers noted that more needs to be done to ensure patient access to a wide range of hearing health technologies, including Medicare coverage of hearing aids that are fit by audiologists and hearing instrument specialists. The Members also cited key recommendations within the hearing care associations' consensus white paper, including:

• Product requirements for appropriate OTC hearing devices targeting mild-to-moderate hearing impairment; 

• Concise, outside-of-the-box labeling appropriate for OTC with strong recommendations to consult with a hearing health care professional;
• Comprehensive, inside-the-box labeling appropriate for OTC medical devices;
• A new OTC category definition that is easily comprehensible by consumers and in line with risk class requirements for safety and effectiveness; and 
• Adequate provisions for consumer protection in coordination with the Federal Trade Commission (FTC). 

"When Congress passed legislation to allow OTC hearing devices, it did so to achieve the bipartisan goal of better serving the American public with affordable, accessible hearing technologies," the lawmakers write. "While we remain committed to that goal, we fear that unclear regulations will lead to widespread misuse of amplifiers that do not address hearing loss and can exacerbate the underlying problems due to poor self diagnosis." 

9.16.21_hearing_health_letter.pdf
File Size:	61 kb
File Type:	pdf

Download File

---