- Galaxy Buds gain FDA approval as over-the-counter (OTC) headphones hearing aid for mild to moderate hearing loss.
- They integrate clinical-grade audiometry and NAL-NL2 algorithms directly into the hearing aid hardware without the need for separate applications.
- The feature will be gradually released in the fourth quarter of 2026 in select markets, revolutionizing hearables.
The 1,5 billion people and the stigma
The FDA ’s decision to approve the Galaxy Buds as an OTC assistive device isn’t just another regulatory feat. According to the World Health Organization , more than 1,5 billion people worldwide experience some form of hearing loss. But the market for traditional hearing aids has been stuck for decades at prices that prohibit access for lower-income people.
This is where Samsung Electronics, in collaboration with National Acoustic Laboratories , steps in . Instead of paying thousands of euros for specialized medical devices, you turn your everyday gadget into a health tool. The social stigma is broken when your headset looks exactly like the common wireless headphones you wear to listen to music at work or on the subway.
How the NAL-NL2 algorithm works
Hardware alone is not enough to replace an otolaryngologist. The system is based on the NAL-NL2 standard, the global clinical reference formula for adjusting medical devices. During the five-minute hearing test, the SaMD software scans each ear individually with pure tone audiometry. As confirmed by clinical trials conducted at Vanderbilt University , the accuracy of the audiogram is comparable to professional clinic equipment.
Then, beamforming and noise-cancelling algorithms take over to selectively boost the high frequencies and whispers lost in the street noise. It’s not just a simple volume boost, but dynamic equalization tailored to your individual hearing profile. You can read more about the developments in connected wearables in our analysis of smart network accessories.
Our opinion at TechNoid
We at TechNoid believe that this move by Samsung is a game-changer in the hearables industry. Medical technology should be accessible and invisible, away from bulky designs that scream “disability.” However, we have a slight reservation about how the general public will interpret the results of the self-administered test. Ease of use should not completely replace medical advice in more serious cases. If you have mild to moderate hearing loss, the Galaxy Buds are the way to go. But if symptoms persist, no software upgrade can replace a doctor.
| Feature | Galaxy Buds (Hearing Aid Mode) | Traditional OTC Headphones |
|---|---|---|
| Price / Access | Integrated into an existing gadget | High purchase cost |
| Social Stigma | Zero (looks like regular headphones) | Visible medical device |
| Clinical Standard | NAL-NL2 & FDA Cleared SaMD | Varies depending on brand |
Frequently Asked Questions about the Hearing Aid feature on Galaxy Buds
Which Galaxy Buds models support hearing aid mode?
The feature is supported on Galaxy Buds3 Pro and Galaxy Buds4 Pro after the relevant upgrade.
Do I need a prescription for activation?
No, the operation is FDA-approved as an over-the-counter (OTC) solution.
What ages is the service aimed at?
Use is intended for adults aged 18 years and older with mild to moderate hearing loss.
How long does it take to get a hearing test?
The self-administered hearing test is completed in just five minutes directly from the settings.
Is a separate mobile app required?
No, the setup is done internally through the Galaxy Buds menu and is integrated into Samsung Health.
When will the feature be available in the market?
Launch is expected in the fourth quarter of 2026 in the US and select approved markets.
What clinical formula is used for sound?
The system leverages the global clinical standard NAL-NL2 for ultimate personalization.
