PARIS, FRANCE – EssilorLuxottica announced today that it has received clearance from the Food and Drug Administration (FDA) for its OTC Nuance Audio Glasses. The Group has simultaneously achieved the CE marking under the Medical Devices Regulation in the EU, alongside the development of an ISO Quality Management System certification dedicated to Hearing Aids, which will allow Nuance Audio to launch in Europe.
Nuance Audio Hearing Aid Software is the first FDA-cleared, preset Software as a Medical Device (SaMD) in the U.S., introducing a new category in the med-tech space. The software provides an open-ear hearing solution integrated into a pair of smart glasses, combining visual and auditory support in a single device.
Designed to address longstanding adoption challenges related to comfort and visibility, Nuance Audio aims to offer a functional and discreet alternative for individuals seeking both vision and hearing assistance.
US and EU Launches Planned
Nuance Audio will be available for purchase in the U.S. beginning in Q1. In the first half of 2025, it will be available in certain European countries, including France, Germany and UK, starting progressively from Italy in Q1, in parallel with U.S. market.
As part of EssilorLuxottica ’s open business model, the Group will leverage its extensive retail network, while also engaging both traditional audiology practices and optical wholesale customers to make this technology accessible to consumers wherever possible.
“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”
–Francesco Milleri, Chairman and CEO of EssilorLuxottica
The global hearing solutions market remains underserved, much like the vision market decades ago, where consumers are often hesitant to wear corrective devices due to factors such as stigma, discomfort, cost, and limited accessibility. Nuance Audio seeks to overcome these barriers, which have hindered the widespread adoption of traditional hearing aids. With the introduction of Nuance Audio Glasses, the company aims to meet the needs of approximately 1.25 billion people worldwide who experience mild to moderate hearing loss.
About EssilorLuxottica
EssilorLuxottica is a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. With a presence in 150 countries, over 200,000 employees, and a vast network of 650 operations facilities and 18,000 stores, the company generated €25.4 billion in revenue in 2023. Its mission is to help people worldwide see more and be more by addressing both vision needs and personal style aspirations.
The company is home to advanced lens technologies such as Varilux, Stellest, and Transitions, as well as iconic eyewear brands like Ray-Ban and Oakley. It also operates leading global retailers including LensCrafters and Sunglass Hut. Through its OneSight EssilorLuxottica Foundation, the company has provided sustainable vision care to over 760 million people in underserved communities. EssilorLuxottica is publicly traded on Euronext Paris and is included in the Euro Stoxx 50 and CAC 40 indices. More information is available at www.essilorluxottica.com.
Source: EssilorLuxottica
