Samsung will receive FDA approval: Galaxy Buds will become hearing aids
- The FDA has approved the hearing aid function in Galaxy Buds 3 Pro and Buds 4 Pro.
- Testing and setup are available to users 18+ with moderate hearing loss
- The update will be released in the fourth quarter of 2024
Samsung Electronics has received permission from the U.S. Food and Drug Administration (FDA) to use its wireless earbuds as a medical device. The 'Hearing Aid' feature will be available only for the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro models and will appear after a software update scheduled for the last quarter of 2024.
According to FDA regulations, this feature will be available to U.S. citizens over the age of eighteen who have been diagnosed with moderate or mild hearing loss. The built-in 'Hearing Test' allows the user to assess their hearing acuity independently, and the system automatically adjusts amplification levels based on individual hearing system characteristics.
Technical details and requirements
For the full functionality, the Samsung Health app and One UI version 8 or higher are required. The software is capable of amplifying high frequencies, whispers, and voices at a distance, as well as supporting active noise cancellation and directional sound isolation.
Developers emphasize that the setup takes about five minutes: the user selects the desired mode, takes a test, and receives personalized amplification. Meanwhile, the headphones continue to perform their usual functions – playing music, making calls, and working with voice assistants.
Samsung's initiative began in 2020 when the company started exploring the potential of its audio devices in a medical context. By 2021, clinical trials conducted in collaboration with independent laboratories were completed, confirming the safety and effectiveness of the sound processing algorithms.
According to the World Health Organization, more than 1.5 billion people worldwide are experiencing hearing loss, and by 2050 this number could rise to 2.5 billion. The high cost of traditional hearing aids, stigma, and limited access to medical services leave a large portion of those in need without assistance.
The introduction of the feature in consumer headphones may lower the financial barrier and expand access to basic audio support. Users who already own Galaxy Buds 3 Pro or Buds 4 Pro will have the opportunity to turn them into a medical device without additional costs for a separate device.
Experts note that this approach opens new prospects for the integration of technology in healthcare, but emphasize the importance of quality control and compliance with regulatory requirements. Currently, the feature is only available in the USA, but Samsung plans to expand it to other markets after obtaining the necessary certifications.
Source: 3DNews
