Industry News
EssilorLuxottica Secures Regulatory Clearance for Nuance Audio Glasses
EssilorLuxottica has announced that its Nuance Audio Glasses have received clearance from the U.S. Food and Drug Administration (FDA) as an over-the-counter (OTC) hearing aid solution. Simultaneously, the company has secured CE marking under the European Union’s Medical Devices Regulation, paving the way for a European launch in 2025.
Nuance Audio represents a groundbreaking innovation in the med-tech space, introducing the first FDA-cleared preset Software as a Medical Device (SaMD) hearing aid solution in the U.S. The technology integrates open-ear hearing enhancement into a sleek and stylish pair of smart glasses, addressing long-standing barriers to hearing aid adoption, such as comfort and visibility. Nuance Audio allows consumers to enjoy clear vision and improved hearing in a single, aesthetically designed product.
The company has outlined its phased rollout strategy, with Nuance Audio becoming available for purchase in the U.S. starting in the first quarter of 2025. The European launch will follow shortly, beginning in Italy in Q1 and expanding to key markets such as France, Germany, and the UK in the first half of the year.
“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.
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.
This launch marks a significant milestone in the convergence of eyewear and hearing solutions, reinforcing EssilorLuxottica’s position as an innovator in both industries. As the global population ages and demand for discreet, multifunctional assistive devices rises, Nuance Audio is poised to redefine the hearing aid market.
