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title: Smartphones And The Next Generation Of Hearing Aids
description: Samsung&#x27;s Galaxy Buds recently received FDA approval as over-the-counter hearing aids, following Apple&#x27;s AirPods getting similar clearance in 2024. The piece...
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og:description: Samsung&#x27;s Galaxy Buds recently received FDA approval as over-the-counter hearing aids, following Apple&#x27;s AirPods getting similar clearance in 2024. The piece...
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# Smartphones And The Next Generation Of Hearing Aids

**[Hackaday](https://daily.dev/sources/hackaday)** · 7 min read · 0 upvotes · 0 comments

## Summary

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.

## Full article

daily.dev links to this article rather than hosting it. Read it at the original source: <https://hackaday.com/2026/08/18/smartphones-and-the-next-generation-of-hearing-aids>

## Questions this post answers

### What did the FDA approve for Samsung Galaxy Buds regarding hearing aids?

The FDA cleared Samsung's Galaxy Buds hearing aid feature to be sold as an over-the-counter hearing aid, following a similar approval for Apple's AirPods in 2024. This means owners can enable the hearing aid functionality via a software update rather than buying a separate dedicated device, since Galaxy Buds already meet the FDA's OTC hearing aid technical requirements.

_Track how major platforms turn consumer earbuds into regulated medical devices by following daily.dev._

### What technical requirements must a device meet to be classified as an OTC hearing aid by the FDA?

An FDA-compliant OTC hearing aid must use air-conduction, meaning a speaker inserted into the ear canal rather than bone conduction, and must let users adjust output to match their needs, typically through selectable pre-defined audio filter profiles rather than a bespoke audiologist-programmed response. Wireless connectivity to a companion device, like a smartphone, is also explicitly permitted under the 2022 FDA framework.

_Developers building assistive audio software can follow evolving OTC hearing aid standards on daily.dev._

### What is the difference between a hearing aid and a Personal Sound Amplification Product (PSAP)?

A hearing aid selectively amplifies specific frequencies tailored to a wearer's measured hearing loss, typically based on an audiogram from an audiologist, while a PSAP simply amplifies all incoming audio indiscriminately without any frequency-specific tuning. Since the 1980s, digital hearing aids have used this targeted frequency approach, whereas older or budget devices behave more like PSAPs.

_Engineers exploring assistive audio hardware can dig into these distinctions via daily.dev._

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