EssilorLuxottica has received U.S. Food and Drug Administration (FDA) clearance in the United States and CE marking in the European Union for its Nuance Audio Glasses, allowing for their market launch in both regions. The device, which integrates hearing aid functionality into a pair of smart glasses, is designed to offer both vision and hearing support in a single product.

The glasses target individuals with mild to moderate hearing loss, which is estimated to affect 1.25 billion people worldwide, according to an EssilorLuxottica press release. They are the first FDA-cleared preset Software as a Medical Device hearing aid in the U.S., and they offer an open-ear hearing solution for comfort and visibility vs traditional hearing aids.

“Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear,” said Francesco Milleri, Chairman and CEO of EssilorLuxottica. “We didn’t just aim to combine two medical devices—we created an entirely new smart glasses form factor to support the two human senses we depend on the most.”

Sales of the product are expected to begin in the United States. in Q1. In Europe, they will be rolled out gradually, beginning with Italy in Q1, followed by France, Germany, and the United Kingdom in the first half of 2025.