The Hearing Industries Association (HIA) has announced its endorsement of the five recommendations in the paper, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness,” and applauds the rigorous efforts by the consensus paper’s Working Group to develop the unified recommendations.
A consensus paper developed by the American Academy of Audiology (AAA), Academy of Doctors of Audiology (ADA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS) was released earlier today in response to the US Food and Drug Administration (FDA) Congressional mandate to create new regulations for over-the-counter (OTC) hearing devices. According to HIA, the paper seeks to find a careful balance between issues of consumer access and affordability while ensuring safety and effectiveness in all hearing aid devices.
As detailed in an article in The Hearing Review, the five recommendations set forth in the consensus paper address:
- The product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment;
- Outside-of-the-box labeling appropriate for medical devices sold over-the-counter;
- Comprehensive inside-the-box labeling;
- Naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and
- Establishing strong consumer protection laws.
Kate Carr
HIA says the above recommendations align with HIA’s mission of innovation, public safety and education. Specifically, the recommendations promote innovations in hearing health care and technology while maintaining high standards for patient safety and product effectiveness, says the organization which is the major US trade association for hearing aid and device manufacturers. Since the passage of the OTC Hearing Aid Act of 2017, HIA and its members have closely monitored activity on OTC solutions to ensure the safety and effectiveness of all products, including those in this new category the FDA must define by August 2020.
“Providing guidance to help people with a hearing loss make the best hearing health decision in this emerging environment is critically important,” said HIA President Kate Carr. “Many people do not recognize or act on their hearing loss until it negatively impacts their personal or professional lives. We endorse the recommendations set forth by this group of esteemed hearing care professionals and hope that the new category to be defined by the FDA will promote more accessible hearing health for all.”
Source: HIA
