Samsung Galaxy Buds Gain FDA Clearance as OTC Hearing Aids
The tech giant will integrate medical-grade diagnostics and amplification into its Pro earbuds by late 2026.
Samsung Electronics has received FDA clearance to market its Galaxy Buds Hearing Aid feature as an over-the-counter (OTC) hearing aid. The move transforms compatible consumer earbuds into regulated medical devices capable of diagnosing and treating hearing deficits.
The system will be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro, targeting adults 18 and older with perceived mild to moderate hearing loss. According to Samsung, the integration includes a "Hearing Test" registered as a Software as a Medical Device (SaMD) and a "Hearing Aid" feature that provides personalized amplification. The Hearing Test can be completed in five minutes and generates an audiogram comparable to a professional evaluation. To ensure clinical accuracy, the system utilizes the NAL-NL2 clinical standard formula, the same standard used for fitting prescription hearing aids.
A Long-Term Health Strategy
This clearance is the culmination of a development cycle that began in 2020, when Samsung first introduced a Personal Sound Amplification Product (PSAP) on the Galaxy Buds+. To move from simple amplification to a regulated medical solution, Samsung collaborated with the National Acoustic Laboratories (NAL) and Samsung Medical Center. The technology underwent rigorous validation studies at several academic institutions, including San Jose State University, the University of Memphis, and Vanderbilt University Medical Center.
Lowering the Barrier to Care
By embedding medical-grade tools into a mass-market product, Samsung is directly challenging the traditional hearing aid industry and competing with Apple's recently FDA-cleared hearing aid features for AirPods Pro. The shift aims to reduce both the financial cost and the social stigma associated with hearing loss, which affects an estimated 1.5 billion people globally.
Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience Business at Samsung Electronics, stated that the FDA clearance allows the company to expand access to hearing support and make proactive care "effortless" by integrating these functions directly into the earbuds.
Market Rollout
Samsung has scheduled the official launch for the fourth quarter of 2026. The feature will first debut in the United States and other select approved markets. While the hardware is already in the ecosystem, the software rollout will mark the transition of the Galaxy Buds from a lifestyle accessory to a certified health tool.