Samsung has exciting news for users experiencing mild to moderate hearing loss. The company has received approval from the US Food and Drug Administration (FDA) for a new feature on its Galaxy Buds that allows them to function as an over-the-counter (OTC) hearing aid. This development is a step towards making hearing support more accessible for individuals 18 and older.
Along with amplifying sounds, the Galaxy Buds also include a Hearing Test feature that offers users a way to gauge their hearing. This feature is registered as Software as a Medical Device (SaMD) and promises medical-grade results.
Hon Pak, Senior Vice President at Samsung Electronics, emphasized the importance of hearing health. He stated that it deeply affects how people interact with others and experience the world around them. He added that this FDA clearance allows Samsung to offer improved access to hearing support, integrating both the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.
Samsung first introduced a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+ in 2020, which was validated in 2021 for supporting daily communication for people with hearing loss.
For this new hearing solution, Samsung worked closely with the National Acoustic Laboratories (NAL) and the Samsung Medical Center (SMC). Extensive validation studies conducted at notable institutions like Vanderbilt University Medical Center and the University of Memphis back the technology. The Hearing Aid feature is designed to amplify sounds that users struggle to hear, personalizing the experience according to each individual’s hearing profile.
In addition to basic amplification, the hearing aid offers advanced features commonly found in premium devices, such as noise cancellation and beamforming. These features help to focus on sounds coming from the front while reducing background noise.
The Hearing Aid and Hearing Test features will be available on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the US and select approved markets starting in Q4 2026.
