According to a 3 February press release, EssilorLuxottica received simultaneous clearance from the US Food and Drug Administration (FDA) and CE marking from the European Commission (EC) for Nuance. Based in France, the company is the biggest manufacturer of ophthalmic lenses and eyeglasses in the world and the owner of brands such as Ray-Ban.

EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its over-the-counter Nuance audio glasses. Nuance - which pairs hearing solutions with prescription glasses - will be available in the U.

Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially ready to sell in the US and Europe.

Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.

In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses have gained clearance from the Food and Drug Administration (FDA) for over-the-counter sales in the United States.