Samsung is one of the companies integrating Auracast into its ecosystem, notably its phones and earbuds. Now it has gone a step further and received approval for its Galaxy Buds to be used as a hearing aid in the United States. The country’s Food and Drug Administration (FDA) has to give permission for companies to retail products as health devices, and they have given the green light to let Samsung sell compatible...
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Signed responses from readers of the wire.
No actionable change to clinical practice; audiologists should be aware that another major consumer-electronics brand has entered the OTC hearing aid market, which may prompt patient questions about suitability compared to prescription devices.
Samsung's FDA-cleared OTC hearing aid entry accelerates the convergence of consumer electronics and regulated hearing care, expanding access while intensifying competitive pressure on traditional hearing aid dispensers.
- 01Samsung Galaxy Buds have received FDA clearance to function as OTC hearing aids in the U.S.
- 02Auracast Bluetooth audio-broadcasting technology is integrated, enabling direct streaming from compatible public venues.
- 03OTC status means adults with mild-to-moderate hearing loss can purchase without a professional fitting or prescription.
- 04This marks a major consumer-electronics brand formally entering the regulated OTC hearing aid space.
- 05The in-app hearing test displays results as a basic audiogram and prompts hearing aid setup directly on the device.
Samsung Galaxy Buds have received FDA approval (clearance) to function as an over-the-counter hearing aid in the United States.
press releasesupportedAuracast wireless audio broadcasting technology is integrated into the Galaxy Buds hearing aid feature.
press releasesupported