Samsung Electronics announced that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible Galaxy Buds 1 to function as over-the-counter (OTC) hearing aids 2 for adults age 18 and older with perceived mild to moderate hearing loss....
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Clinicians should be aware that patients with self-perceived mild-to-moderate hearing loss may present having already adopted Galaxy Buds as OTC hearing aids; counselling on appropriate use, limitations, and when to seek a formal audiological evaluation remains important.
FDA clearance of a mainstream consumer earbuds brand as an OTC hearing aid significantly lowers the barrier to hearing help and intensifies competitive pressure on traditional hearing aid dispensing.
- 01Samsung Galaxy Buds received FDA clearance to function as an OTC hearing aid.
- 02Indicated for adults 18 and older with self-perceived mild-to-moderate hearing loss.
- 03No prescription or audiologist visit required under OTC rules.
- 04Samsung becomes one of the biggest consumer electronics brands with a cleared hearing aid product.
- 05Clearance reported on hearinghealthmatters.org, an independent audiology blog.
Samsung Galaxy Buds Hearing Aid feature has received FDA clearance as an OTC hearing aid for adults 18+ with mild-to-moderate hearing loss.
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