US Food and Drug Administration Finalizes Rules for Over-the-Counter Hearing Aids
Five years after the original OTC hearing aid act was signed into law on August 18, 2017, the US Food and Drug Administration (FDA) issued a final rule establishing Over-the-Counter (OTC) hearing aids. The FDA also issued the final Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, clarifying the differences between hearing aids, which are medical devices, personal sound amplification products, and the new category of OTC hearing aids, which can be purchased directly from stores or online.
