The FDA gave Samsung Electronics the go-ahead for the latest software features that allow its Galaxy Buds earphones to act as an OTC hearing aid that also allows users to diagnose their hearing.
The hearing test feature is registered as a software for medical device and provides medical-grade results, the company said in an August. 11 press release.
More than 1.5 billion people globally have some degree of hearing loss, which the World Health Organization forecasts will grow to 2.5 billion by 2050, according to Samsung.
“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,” Hon Pak, senior vice president and head of Samsung’s digital health team for its mobile experience unit, said in a statement.
The approved features are part of the device and don’t require a separate app, allowing users to navigate the Galaxy Buds menu in settings where they can run a complete hearing test in five minutes.
Samsung first offered its personal sound amplification product (PSAP) in its Galaxy Buds+ product in 2020. The following year it was clinically validated as an effective support for hearing loss.
The latest features were the result of a collaboration with National Acoustic Laboratories of Australia and the Samsung Medical Center in Seoul. Clinical validation was conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
The new features are expected to be available in the U.S. and select approved markets by the end of the year.
Just under two years ago, the FDA gave its first de novo approval for OTC hearing aid software features to Apple for use in its premium AirPods. The regulatory agency officially opened the door to prescription-free hearing aid tech in 2022.
https://www.fiercebiotech.com/medtech/samsung-hearing-aid-features-its-ear-buds-garner-fda-clearance
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