On August 11, 2026, Samsung Electronics revealed that the ‘hearing aid’ capability of its Galaxy Buds smart earbuds has secured approval from the US Food and Drug Administration (FDA) for utilization as an over-the-counter medical assistive device. This functionality is set to debut in the US and select international markets during the fourth quarter of this year. It will be compatible with the Galaxy Buds 3 Pro and 4 Pro models, specifically catering to individuals aged 18 and older who experience mild to moderate hearing impairment. The integrated hearing test feature, classified as medical device software, is capable of conducting a comprehensive assessment within a mere 5 minutes and subsequently automatically fine-tunes the hearing aid parameters. Samsung has worked in tandem with numerous medical institutions to accomplish clinical validation, with the overarching goal of reducing the obstacles to obtaining hearing assistance and enhancing the availability of hearing aid products.