The two hearing aid features have been approved by the Ministry of Food and Drug Safety
Samsung’s Galaxy Buds Pro 4 (pictured) were launched alongside its Galaxy foldables
Samsung announced that it has now received approval from the South Korea's Ministry of Food and Drug Safety (MFDS). This approval follows the earlier US Food and Drug Administration (FDA) certification for its hearing aid features on its Galaxy Buds TWS earphones. The MFDS approval means that Samsung can now begin rolling out the feature for supported Galaxy Buds TWS earphone models. Samsung now claims that it will begin the rollout of its two hearing aids features starting with South Korea early next year, enabling owners to use their Galaxy Buds as hearing aid devices.
According to Samsung, the company has now obtained “medical device” approval from the Ministry of Food and Drug Safety (MFDS) in South Korea. The approval now means that Samsung can roll out its ‘Hearing Test' and ‘Hearing Aid' features to supported devices. This short list of devices as per Samsung, includes the recently launched Galaxy Buds 4 Pro and last year's Galaxy Buds 3 Pro TWS earphones.
Samsung claims that both TWS earphones will receive their hearing aid features via software updates “early next year”. The roll out of the feature is said to begin with South Korea and may expand to more countries later.
Since Samsung had earlier managed USFDA approval, we can expect the two hearing aid features to make their way to Galaxy Buds owners in the US as well. However, Samsung has not provided a defined timeline for the same.
Two features include the ‘Hearing Test' and the ‘Hearing Aid', which will basically let Galaxy Buds 4 Pro and Buds 3 Pro owners use their TWS earphones as medically approved hearing aid devices.
The ‘Hearing Test' feature lets users take a clinical-grade test to check their hearing using the TWS earphones. The test plays single tones at different frequencies and then presents an audiogram, which lets the user know which hearing loss category they belong to. Samsung says the test will put the user into one of seven hearing loss categories which include: normal, slight, mild, moderate, moderately severe, severe, and profound.
The ‘Hearing Aid' feature uses the test data and will accurately amplify the sounds that the user struggles to hear. According to Samsung, the system uses the NAL-NL2 fitting formula, recognised as a clinical standard for prescription hearing aids. The technology was developed with National Acoustic Laboratories and Samsung Medical Centre, with clinical studies carried out at the Vanderbilt University Medical Centre, San Jose State University and the University of Memphis.
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