#FDA #Samsung #Galaxy Buds

Samsung Galaxy Buds Earn FDA Approval for Hearing Aid Feature

In an exciting development for auditory health, Samsung Electronics has announced that its Galaxy Buds have received approval from the U.S. Food and Drug Administration (FDA) to function as over-the-counter (OTC) hearing aids. This innovative feature allows users with mild to moderate hearing difficulties to utilize the Galaxy Buds as hearing support devices, making auditory assistance more accessible and convenient than ever.

The Galaxy Buds can now be used by individuals aged 18 and above who experience challenges in noisy environments, such as struggling to listen to conversations without the need for prescriptions or professional medical consultations. Moreover, users can assess their hearing capabilities directly through the built-in audiometry feature, which has been registered as Software as a Medical Device (SaMD), ensuring that they receive accurate, medical-grade results.

Revolutionizing Hearing Support

Hon Pak, Vice President and Head of the Digital Health Team at Mobile eXperience (MX) within Samsung, expressed the importance of auditory health, stating: "Hearing health is a crucial aspect of our overall well-being, significantly impacting communication, connections with loved ones, and social engagements. With this FDA approval, we will broaden access to hearing support, making preventive care much easier to engage in."

Hearing impairment is an incredibly common condition, yet it remains a largely underappreciated health issue globally. The World Health Organization (WHO) estimates that over 1.5 billion individuals suffer from some form of hearing loss, a number that is forecasted to reach 2.5 billion by 2050. Alarmingly, many could benefit from hearing aids but are deterred by high costs, social stigmas, and limited access to specialized care.

Samsung has been dedicated to advancing consumer hearing support technology since 2020, launching the Personal Sound Amplification Product (PSAP) feature with the Samsung Galaxy Buds+. This PSAP feature was clinically validated in 2021 as an effective means to assist daily communication for those with hearing challenges. The newly developed OTC hearing aid function builds upon this foundation through close collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC), with its efficacy supported by rigorous clinical studies conducted at esteemed institutions like Vanderbilt University Medical Center and San Jose State University.

Seamless User Experience

Samsung's comprehensive hearing healthcare experience is built around two primary features embedded in the Galaxy Buds, which do not require users to download any additional applications. Users can undergo a self-administered hearing test in about five minutes via the Samsung Galaxy Buds settings menu. A clinically precise pure-tone hearing test software measures each ear individually, identifying the user's unique auditory profile. Following the test, an audiogram, comparable to evaluations by certified audiologists, is provided, classifying the results as