The US Food and Drug Administration (FDA) has approved a feature that allows compatible Samsung Galaxy Buds3 Pro and Galaxy Buds4 Pro wireless earbuds to be used as non-prescription hearing aids for adults with perceived mild to moderate hearing loss, according to a company announcement.
Who can use it
Samsung says the new feature applies to the Galaxy Buds3 Pro and Galaxy Buds4 Pro and is intended for users aged 18 and over. The company notes that the Hearing Aid feature can be used without a medical prescription or a prior visit to a specialist, though it is not a substitute for professional diagnosis and treatment.
How the hearing test works
The compatible earbuds also include a Hearing Test feature, allowing users to check their hearing. According to the company, the process takes around five minutes and examines each ear separately, using pure-tone audiometry. Based on the results, an audiogram is generated, and hearing is classified as normal or as mild, moderate, severe or profound loss.
How the hearing aid feature works
The hearing aid feature then adjusts amplification of specific sounds according to the user's hearing profile. Among other things, it can boost high frequencies, quiet voices and sounds coming from further away. The earbuds also support background noise reduction and beamforming technology, designed to better focus on sounds coming from the direction the user is facing.
Development and standards
According to the company, amplification is calibrated using the NAL-NL2 standard, the same standard used to calibrate conventional hearing aids. The technology was developed in collaboration with the National Acoustic Laboratories and the Samsung Medical Center, with validation studies carried out at US university institutions, the company says.
A widespread public health issue
Hearing loss is a widespread public health problem. According to World Health Organization figures cited in the announcement, more than 1.5 billion people worldwide experience some degree of hearing loss, a number estimated to reach 2.5 billion by 2050.
The Hearing Aid and Hearing Test features are expected to become available in the US and in selected approved markets in the fourth quarter of 2026.
