As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness” products such as earbuds that can also amplify and clarify surrounding speakers’ voices and regulated medical devices such as conventional hearing aids. On January 6, 2026, the U.S. Food and Drug Administration issued new guidance documents clarifying how it interprets existing law for the review of wearable and AI-assisted devices. The first document, for general wellness, specifies that the FDA will interpret noninvasive sensors such as sleep trackers or heart rate monitors as low-risk wellness devices while treating invasive devices under conventional regulations.…