
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…

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