According to EssilorLuxottica, the software housed in the glasses – called Nuance Audio Hearing Aid Software – is the first FDA-cleared, preset Software as Medical Device (SaMD) in the US. The ...

Nuance Audio showcased its glasses with built-in hearing aids at CES 2025. Now that the product is FDA-approved, it will be available in the US in the coming months.

EssilorLuxottica's Nuance Audio Glasses receive FDA clearance for OTC sales in the US, revolutionizing hearing solutions with smart glasses.

The Nuance Audio hearing aid smart glasses have received FDA clearance and a CE marking in the EU, clearing the way for a Q1 launch.