Samsung’s Galaxy Buds Hearing Aid feature receives FDA clearance as an OTC hearing aid for adults with perceived mild to moderate hearing loss.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Samsung Electronics has received U.S. Food and Drug Administration clearance for its Galaxy Buds Hearing Aid feature, allowing compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids for adults aged 18 years and older with perceived mild to moderate hearing loss. The clearance expands the role of wireless earbuds from consumer audio devices to regulated hearing-support technology that can be accessed without a prescription or clinic visit.
FDA Clearance Expands Access to Hearing Support
The FDA established the OTC hearing-aid category in 2022 for adults with perceived mild to moderate hearing loss, allowing eligible consumers to purchase hearing aids without a medical examination, prescription or professional fitting.
Samsung’s Hearing Aid feature operates directly through compatible Galaxy Buds. The company says the technology can help users who struggle to follow conversations in noisy environments, hear distant voices or distinguish quieter sounds.
The feature builds on Samsung’s earlier work in consumer hearing support. The company introduced a Personal Sound Amplification Product (PSAP) feature with Galaxy Buds+ in 2020 and reported clinical validation of the technology in 2021.
Five-Minute Hearing Test Generates an Audiogram
Samsung’s hearing-health system combines two functions: Hearing Test and Hearing Aid. The Hearing Test is registered as Software as a Medical Device (SaMD) and uses pure-tone audiometry to assess each ear independently.
Users can complete the self-administered assessment in about five minutes through the Galaxy Buds settings. The software generates an audiogram and categorizes hearing as normal or as mild, moderate, severe or profound loss.
Samsung says the test produces results comparable in accuracy to a professional audiological assessment. However, the FDA continues to recommend professional evaluation when symptoms suggest more serious hearing problems or an underlying medical condition. OTC hearing aids are intended only for adults with perceived mild to moderate hearing loss and are not intended to treat severe or profound hearing loss.
Personalized Amplification Uses NAL-NL2
The Hearing Aid feature uses the individual’s hearing profile to adjust amplification. Samsung says it can increase audibility of high-frequency sounds, quieter voices and distant speech while incorporating noise reduction and beamforming to improve speech focus in challenging listening environments.
The system uses NAL-NL2, a widely used hearing-aid fitting prescription, to personalize amplification according to the user’s hearing profile.
Development involved collaboration with the National Acoustic Laboratories and Samsung Medical Center. Clinical validation studies were also conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Hearing Data Integrated into Samsung Health
The company is also integrating hearing-related information into Samsung Health. Users can access Hearing Test results and information such as environmental noise exposure alongside other wellness data.
Hon Pak, senior vice president and head of the Digital Health Team at Samsung Electronics’ Mobile eXperience business, said the FDA clearance broadens access to hearing support by bringing hearing assessment and amplification functions directly into Galaxy Buds.
A Broader Shift Toward Consumer Hearing Devices
The clearance reflects the expanding role of consumer electronics in hearing care following the FDA’s creation of the OTC category. By removing prescription and professional-fitting requirements for eligible adults, the regulatory framework has opened the market to self-fitting and digitally enabled hearing devices.
For Samsung, integrating hearing assessment and amplification into an existing earbud platform could further reduce practical barriers to hearing support. The immediate regulatory indication remains limited to adults with perceived mild to moderate hearing loss, while users with sudden, asymmetric or medically concerning hearing changes should seek evaluation by a healthcare professional.
Reference
Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA – Samsung Global Newsroom
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.
