Ray-Ban owner EssilorLuxottica has received clearance from the Food and Drug Administration (FDA) for the non-prescription sale of its Nuance Audio Glasses, a new technology that combines hearing solutions with prescription glasses.
On Monday, the group announced that it had also been CE-marked under European medical device legislation and certified under the ISO Quality Management System for Hearing Aids, a set of standards designed to help organisations ensure compliance with customer and regulatory requirements by continuously improving their processes, which means its new glasses will be made available in Europe.
The product, which invisibly integrates an open-ear hearing solution into a pair of smart glasses, is now the first FDA-certified SaMD (Software as a Medical Device) in the US.
EssilorLuxottica is a French-Italian multinational company formed from the merger of Essilor and Luxottica in 2018. Its product base covers a wide range of products including ophthalmic lenses, optical equipment, prescription glasses, and sunglasses.
The company owns several well-known brands including Ray-Ban, Persol, and Vogue Eyewear.
With the move, Nuance Audio will be available in the US and Italy from the first quarter of the year. It will then be available in some European countries, including France, Germany and the UK, within the next six months.
EssilorLuxottica said its next steps will involve focusing on using its extensive network of hearing aid channels and optical customers to make the glasses accessible to a wider audience, with a goal of meeting the needs of the approximately 1.25 billion people suffering from mild to moderate hearing loss.
Francesco Milleri, president and chief executive of EssilorLuxottica, said that the idea of creating Nuance Audio Glasses was born two years ago, with the aim of removing the barriers that hindered the adoption of traditional hearing aids.
“From today, we will work to spread this technology with the potential to change the lives of anyone in the world who may need it,” he added.
“Finally, after decades of resistance to the adoption of traditional hearing solutions due to reduced comfort or visibility, consumers will be able to see and hear clearly thanks to a single product,” the Group said in a statement.
Over the past two years, the Group has been actively involved in new tech developments and partnerships.
In September 2024 EssilorLuxottica and Meta entered a long-term contract extending into the 2030s to develop multi-generational smart eyewear products, with a focus on developing augmented reality (AR) glasses.
This partnership aims to integrate advanced technology into stylish eyewear, making products like the Ray-Ban Meta glasses, which offer features such as making phone calls, capturing photos and videos, listening to music, and livestreaming content.
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