Samsung secures FDA clearance for Galaxy Buds hearing aid feature

Samsung has received approval from the US Food and Drug Administration (FDA) for a hearing aid feature integrated into its Galaxy Buds 3 Pro and Galaxy Buds 4 Pro earbuds. The clearance allows the South Korean electronics manufacturer to market the devices as over-the-counter hearing aids for adults aged 18 and over who experience mild to moderate hearing loss.

The feature is scheduled to launch later this year in the United States and select international markets. It introduces a five-minute hearing test tool that users can initiate directly from the Galaxy Buds settings on a compatible Galaxy smartphone. The test evaluates hearing across four distinct stages: normal, mild, moderate, severe, or profound.

Once the assessment is complete, users can view their results within the Samsung Health application. The hearing aid functionality then utilises these results to amplify specific frequencies that the wearer may struggle to hear, such as whispers, distant voices, and high-pitched sounds. This personalised audio adjustment aims to improve clarity without requiring a prescription.

The amplification technology is designed to work in tandem with the earbuds’ existing noise elimination and beamforming capabilities. By combining these systems, the earbuds can focus on audio sources positioned in front of the wearer while suppressing background noise, a configuration similar to the hearing aid features currently available in Apple’s AirPods Pro.

This regulatory milestone underscores Samsung’s expansion into the consumer health sector, leveraging its position in the wearable audio market to offer accessible hearing assistance. The FDA’s approval signifies that the device meets the necessary safety and efficacy standards for marketing as a hearing aid in the United States, distinguishing it from standard consumer audio products.