Samsung Galaxy Buds Are Getting FDA-Cleared Hearing Aid Feature

Samsung has gained FDA clearance to introduce an over-the-counter hearing aid feature for its Galaxy Buds lineup. The company plans to roll out this update later this year for the Galaxy Buds 4 Pro and Buds Pro 3.

This development puts Samsung in direct competition with Apple, which added a similar hearing aid mode to the AirPods Pro 2 in late 2024. This trend shows that premium earbuds are increasingly functioning as medical-grade devices, but without the hefty price tag usually associated with them.

Understanding FDA Clearance

FDA clearance means the U.S. Food and Drug Administration has officially reviewed a product and confirmed its safety and effectiveness for a specific medical use. This isn’t just Samsung labeling its earbuds as “hearing helpers” — it means the feature has received approval to function as an over-the-counter (OTC) hearing aid. You can purchase this type of device without a prescription or a trip to an audiologist.

The OTC hearing aids category became legal in the U.S. in 2022 when the FDA opened the market to devices meant for adults with mild to moderate hearing loss. Before this change, obtaining hearing aids required a doctor’s visit, a professional fitting, and often cost thousands of dollars. The introduction of the OTC category aimed to make hearing aids more accessible.

According to 9to5Google, Samsung’s feature will work alongside a hearing test integrated into the Galaxy wearables app. You can run the test through your phone, and the buds will adjust their audio output based on your specific hearing profile. Essentially, they’ll act like a personalized hearing aid just for you.

Which Devices Will Get This Feature?

As reported by Android Authority, both the Galaxy Buds 4 Pro and the older Buds Pro 3 will support this hearing aid mode. This is great news for those who invested in Samsung’s premium earbuds a generation ago, as they won’t miss out on this new feature.

Samsung hasn’t shared a specific release date yet, only stating that it will come “later this year.”

Daily Use of the Feature

Imagine this: instead of wearing hearing aids that look like traditional devices and cost between $2,000 and $5,000, you could use earbuds you may already have or purchase for a few hundred dollars. These earbuds will help with mild to moderate hearing loss.

Here’s how it would typically work: open the Galaxy wearables app on your Android phone, complete an on-device hearing test (similar to the tone-based tests audiologists use), and the software will adjust your Buds to enhance the specific sound frequencies you’re missing. When you’re not using them for hearing assistance, they still work as normal earbuds.

Engadget mentions that the FDA approval and hearing test will come together, indicating Samsung aims to make the experience feel medically grounded rather than just a simple software toggle.

The Impact of This Development

According to the CDC, around 30 million American adults experience some level of hearing loss, but most of them don’t use hearing aids. Cost and stigma are the main barriers. A feature integrated into earbuds that millions already use really changes the equation.

If you have mild hearing loss and own Galaxy Buds 4 Pro or Buds Pro 3, this update could be incredibly beneficial at no extra cost. For those shopping for earbuds, it gives a compelling reason to choose Samsung’s top models over competitors lacking FDA-cleared hearing support.

However, keep in mind that OTC hearing aids are specifically designed for adults with mild to moderate hearing loss. If you have severe hearing loss or haven’t had your hearing assessed, visiting an audiologist is still the best first step. This feature is intended to complement, not replace, professional care for more serious conditions.

Community Feedback

“This is genuinely useful for people in their 40s and 50s who have mild high-frequency loss but aren’t ready to deal with traditional hearing aids. If it works as well as Apple’s implementation, this is a big deal.”

“Cool feature but we need to know how well the hearing test actually works before getting excited. Apple’s version got mixed reviews from audiologists when it launched.”

What to Keep an Eye On

• Release Timing: Samsung mentioned “later this year” but hasn’t set a specific date. Look out for a software update announcement related to the Galaxy Buds app, likely in fall 2026.
• Audiologist Response: When Apple launched its hearing aid feature, some professionals praised the accessibility while others questioned the accuracy of the tests. Expect a similar discussion when Samsung’s feature debuts.
• Expansion to Other Buds Models: Currently, only the Buds 4 Pro and Buds Pro 3 are confirmed. It’ll be interesting to see if Samsung adds support for mid-range Galaxy Buds models in future updates.
• Google’s Move: With Apple and Samsung now in the OTC hearing aid space, many are curious to see if Google will seek FDA clearance for Pixel Buds in 2026 or 2027.