Samsung's Galaxy Buds recently received FDA approval as over-the-counter hearing aids, following Apple's AirPods getting similar clearance in 2024. The piece explains the 2022 FDA framework that created the OTC hearing aid category, distinguishing true hearing aids from simple sound amplifiers (PSAPs) by their ability to selectively adjust frequency output. It covers the technical requirements the FDA mandates (air-conduction, adjustable output) and discusses how smartphone integration lets these devices offer audio profile switching and even built-in hearing tests, suggesting lessons for open-source hearing aid hackers even though FDA approval isn't their goal.
Source: https://hackaday.com/2026/08/18/smartphones-and-the-next-generation-of-hearing-aids. 8 Sync News only summarizes and links out; content copyright belongs to the authors and original sources.
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