Summary:
EssilorLuxottica has received FDA clearance and CE marking for its Nuance Audio Glasses, a smart eyewear solution featuring integrated open-ear hearing aid technology, set to launch in the U.S. and Europe in 2025.
Key Takeaways:
- Regulatory Approvals & Market Entry – Nuance Audio Glasses have secured FDA clearance in the U.S. and CE marking in the EU, paving the way for their global launch.
- Innovative Smart Glasses – The product combines vision correction with hearing aid functionality in a sleek, comfortable design to address long-standing adoption barriers.
- Global Accessibility – EssilorLuxottica will leverage its retail network and audiology partnerships to make the technology widely available, targeting over 1.25 billion people with mild to moderate hearing loss.
EssilorLuxottica 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.
Paving the way for a new category in the med-tech space, Nuance Audio Hearing Aid Software is the first FDA cleared, preset Software as Medical Device (SaMD) in the United States. It delivers a novel open-ear hearing solution seamlessly integrated into a pair of stylish smart glasses. After decades of adoption barriers ranging from comfort to visibility, the company says consumers will finally be able to see clearly and hear clearly with a single product that is designed to be both beautiful and highly functional.
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 the UK, starting progressively from Italy in Q1, in parallel with the 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,” says said Francesco Milleri, Chairman and CEO of EssilorLuxottica. “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.”
According to 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 billion1 people worldwide who experience mild to moderate hearing loss.
Notes:
1 World Health Organization, World Report on Hearing, 2021, p. 40.