Samsung announced on September 18, 2026 that the hearing aid feature built into its Galaxy Buds has received clearance from the U.S. Food and Drug Administration (FDA) as an over-the-counter (OTC) medical device. The feature works on two models, Galaxy Buds3 Pro and Galaxy Buds4 Pro, letting users aged 18 and older with mild to moderate hearing loss take a hearing test and use sound amplification without visiting a doctor. Availability in the U.S. is planned for the fourth quarter of 2026.

Hearing care built entirely into the Galaxy Buds

The clearance covers two features accessible from the Galaxy Buds settings menu: a hearing test and a hearing aid function. The hearing test takes about five minutes and uses software built around clinical-grade pure-tone audiometry to measure each ear separately. The results are presented as an audiogram comparable in precision to an assessment by a professional audiologist, sorting hearing ability into five categories: normal, mild, moderate, severe, and profound. The hearing test component is registered as Software as a Medical Device (SaMD), which Samsung says allows it to deliver medical-grade results.

Based on those results, the hearing aid feature amplifies sounds that are hard to hear, such as high-frequency tones, nearby whispers, and distant voices, tailored to each user's own hearing profile. It also includes noise elimination and beamforming that focus on sound coming from the front while suppressing background noise, and it applies NAL-NL2, a fitting formula used worldwide as a clinical standard for prescription hearing aids. Noise exposure levels and hearing test results can also be checked directly in the Samsung Health app, with no separate app required.

Built on work since 2020, validated across three universities

Samsung has been developing hearing support technology since 2020, when it first added a Personal Sound Amplification Product (PSAP) feature to the Galaxy Buds+. That PSAP feature was clinically validated in 2021 as an effective way to support everyday communication for people with hearing loss, and the new hearing aid feature builds on that foundation.

To develop the new feature, Samsung worked closely with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC), with clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis. Hon Pak, who leads the Digital Health team within Samsung's Mobile eXperience (MX) division, said hearing health is a vital part of overall wellbeing that has a major effect on communication and connection with others, adding that the clearance further expands access to hearing support.

Entering a market Apple already leads, as OTC hearing aids grow

In the U.S., the FDA established over-the-counter hearing aids as a distinct product category through a rule that took effect in 2022. Under that framework, Apple was first to secure FDA clearance for a hearing aid feature, on the AirPods Pro 2, in September 2024, later expanding to the U.K. in February 2025 and Australia the following month. The current AirPods Pro 3 now offers three related features: a hearing test, a hearing aid, and hearing protection. Samsung's move puts it in the position of following Apple into this category.

According to the World Health Organization, more than 1.5 billion people worldwide have some degree of hearing loss, a number expected to reach 2.5 billion by 2050. Even so, many people who could benefit from hearing aids do not use them, held back by high costs, social stigma, and limited access to specialized care. Building a hearing test and hearing aid function into an everyday device like earbuds is one way of addressing that gap.

Summary

Samsung has announced that the hearing aid feature on its Galaxy Buds3 Pro and Galaxy Buds4 Pro has received FDA clearance as an over-the-counter medical device. The feature combines a roughly five-minute self-administered hearing test with sound amplification and noise reduction tailored to the user's own hearing profile, and it connects with the Samsung Health app. Rollout in the U.S. is planned for the fourth quarter of 2026, expanding later to other regions with the necessary approvals. While Samsung is following Apple into this space, the growing global population living with hearing loss suggests real value in having more accessible options for hearing care built into everyday earbuds.