Samsung Electronics today announced that its Galaxy Buds Hearing Aid feature has received U.S. The feature enables compatible Galaxy Buds 1 to serve as an over-the-counter (OTC) hearing aid, 2 offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss — which may be indicated by difficulty following conversations in noisy environments — without a prescription or clinic visit.
What happened
Food and Drug Administration (FDA) clearance. Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.
Where the sources line up
“Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world,” said Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics. “With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.
Practical impact for readers
Hearing loss is incredibly common, yet it remains one of the most overlooked health conditions worldwide. The World Health Organization (WHO) estimates that globally, more than 1. 5 billion people experience some degree of hearing loss — a figure projected to reach 2. 5 billion people by 2050. Despite this, many people who could benefit from hearing aids do not use them due to high cost, social stigma or limited access to professional care.
Who should pay attention now
Samsung has been committed to advancing hearing support technologies for consumers since 2020. That year, the company introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+.
What is still unclear
The PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss, building the foundation for the Hearing Aid feature. To develop this new OTC solution, Samsung collaborated closely with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The resulting technology is backed by robust clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Latest comments
0No comments yet. You can start the conversation.