Nuance Audio's GlassesNuance Audio’s Glasses. © EssilorLuxottica

Nuance Audio’s Glasses would change the way people see and hear.

EssilorLuxottica has received FDA approval for its over-the-counter Nuance Audio Glasses. At the same time, the company has secured CE marking in the EU under Medical Devices Regulation and developed an ISO-certified Quality Management System for Hearing Aids, paving the way for a European launch.

Nuance Audio's Glasses (6)Nuance Audio’s Glasses. © EssilorLuxottica

Nuance Audio Hearing Aid Software is the first FDA-cleared, preset Software as a Medical Device (SaMD) in the U.S., offering an innovative open-ear hearing solution built into stylish smart glasses. This breakthrough product overcomes long-standing barriers like comfort and visibility, allowing users to both see and hear clearly with a single, elegant device.

Nuance Audio's Glasses (5)Nuance Audio’s Glasses. © EssilorLuxottica

Nuance Audio will be available in the U.S. starting in Q1 and will roll out in select European markets, including France, Germany, and the UK, in the first half of 2025. The launch will begin in Italy in Q1, alongside the U.S. release.

Nuance Audio's Glasses (4)Nuance Audio’s Glasses. © EssilorLuxottica

As part of its open business model, EssilorLuxottica will use its extensive retail network and collaborate with audiology practices and optical wholesalers to make this technology widely accessible.

Nuance Audio's Glasses (3)Nuance Audio’s Glasses. © EssilorLuxottica

“Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear. 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. It is not only groundbreaking, but also incredibly accessible. We’re pleased now to turn our focus to getting this life-changing technology into the hands of people around the world who truly need it,” said Francesco Milleri, Chairman and CEO of EssilorLuxottica.

Nuance Audio's Glasses (3)Nuance Audio’s Glasses. © EssilorLuxottica

Nuance Audio's Glasses (2)Nuance Audio’s Glasses. © EssilorLuxottica

Nuance Audio's Glasses (1)Nuance Audio’s Glasses. © EssilorLuxottica

source EssilorLuxottica