August 14, 2018
Washington, DC: The major U.S. hearing healthcare professional associations (Associations) today announced the release of a consensus paper, "Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness." The consensus paper was developed by a working group representing all associations to provide guidance to the U.S. Food and Drug Administration (FDA) as it develops an over-the-counter (OTC) hearing device classification as mandated by the FDA Reauthorization Act of 2017 (FDARA). The consensus paper, which outlines five evidence-based recommendations related to the safety and effectiveness of this new class of devices, was jointly developed and endorsed by the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS).
The associations appreciate FDA's recent statement that Section 709 (of FDARA) reflects a careful balance between consumer affordability and access to new technologies, while providing consumer protections to assure safety and effectiveness of OTC hearing aids. The consensus paper introduction, in part, states, "[The Working Group] strongly advocates that any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimize consumers’ awareness and use of appropriate hearing care treatment."
The consensus 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.
The Associations are committed to jointly engaging with the FDA and other stakeholders in the coming months and years, during the continued development of the new OTC hearing device classification.
On the release of the consensus paper, the Association presidents made the following statements:
The consensus paper has already received endorsement by Hearing Industries Association.
To view the full consensus paper, go to www.hearabouthearing.org.