FOR IMMEDIATE RELEASE
Press Contact: Lindsay Robinson
WASHINGTON, DC (August 14, 2018) - Today, 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 in response to the U.S. Food and Drug Administration (FDA) Congressional mandate to create new regulations for over-the-counter (OTC) hearing devices. Titled "Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness", 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.
The Hearing Industries Association (HIA) endorses the five recommendations put forth in the paper and applauds the rigorous efforts by the consensus paper's Working Group to develop the unified recommendations. HIA promotes innovations in hearing health care and technology while maintaining high standards for patient safety and product effectiveness. 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.
The five recommendations set forth in the consensus paper align with HIA's mission of innovation, public safety and education. Specifically, the recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) 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 5) establishing strong consumer protection laws.
"Providing guidance to help people with a hearing loss make the best hearing health decision in this emerging environment is critically important. 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", said Kate Carr, President, Hearing Industries Association.
About Hearing Industries Association:
HIA is the trusted voice in hearing healthcare for patient safety and education, delivery care, innovation and public policy. Headquartered in Washington, DC, HIA is the national trade association of manufacturers of hearing aids, implantable hearing devices, assistive listening devices, component parts, and power sources for amplification devices. https://www.hearing.org