ASHA and three other professional hearing care organizations are advocating to include appropriate labeling and adequate consumer-protection provisions in regulations for a new over-the-counter (OTC) hearing aid category.
These and other recommendations are included in “Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness,” a consensus paper developed by representatives from ASHA, the Academy of Doctors of Audiology (ADA), the American Academy of Audiology (AAA) and the International Hearing Society (IHS).
Under the OTC Hearing Aid Act of 2017, the U.S. Food and Drug Administration must establish a new category of OTC hearing aids available for sale without the involvement of a licensed professional. However, the major professional hearing care organizations emphasize that along with consumer affordability and access to new technologies, the category must also maintain consumer protections and ensure the safety and effectiveness of this new class of hearing aids.
The paper includes five key recommendations that the FDA:
- Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate hearing impairment.
- Define concise, outside‐of‐the‐box labeling appropriate for OTC devices, with strong recommendations to consult with a hearing health care professional.
- Define comprehensive, inside‐the‐box labeling appropriate for OTC medical devices.
- Define the new OTC category so that it is easily understood by consumers and aligns with risk-class requirements for safety and effectiveness.
- Ensure adequate provisions for consumer protection, in coordination with the Federal Trade Commission (FTC).
The document provides the scientific evidence and data to substantiate and support the recommendations, and also suggests how the FDA can incorporate and detail the recommendations in the final regulations. The four associations are committed to advocating together with the FDA and other stakeholders as the OTC hearing device classification is developed.