Eyewear company Essilor Luxottica has announced that its ‘hearing glasses’ – spectacles that include hearing aids – have received approval from the FDA and EU certifications enabling them to be sold in America and Europe.
The company is marketing its Nuance Audio Glasses, which it states audiology practices can access, as a “breaththrough in hearing technology” and an “over-the-counter (OTC) hearing aid integrated into smart glasses for perceived mild to moderate hearing loss in adults aged 18 and over”.
The audio component is invisible as it is embedded within the spectacle frames. Optional lens upgrades, which are not required for use, include customising the glasses with the client’s preferred optical lenses, whether they need a prescription, Transitions lenses or blue light filtering. The product includes a wireless charging pad.
A companion app personalises the listening experience, the company said, while the glasses’ “open-ear design and directional microphones ensure comfort and clarity in challenging auditory environments, such as noisy trains, busy offices, or lively restaurants”.
EssilorLuxottica announced in Paris on 3 February 2025 that it had received clearance from the Food and Drug Administration (FDA) for its OTC Nuance Audio Glasses. The group 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 disruptive 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 US,” EssilorLuxottica said in a statement.
“It delivers a groundbreaking open-ear hearing solution seamlessly integrated into a pair of stylish smart glasses. After decades of adoption barriers ranging from comfort to visibility, consumers will finally be able to see clearly and hear clearly with a single product that is both beautiful and highly functional.”
The glasses will be available for purchase in the US in Q1, and in the first half of 2025, they will be available in European countries including France, Germany and UK, starting progressively from Italy in Q1.
Access for audiology practices
“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,” the company said.
Mr Francesco Milleri, chairman and CEO of EssilorLuxottica, said that two years ago, the business 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.”
The product was recognised as an honoree in the digital health category of the 2025 Consumer Electronics Show (CES) Innovation Awards in Las Vegas from 9 to 12 January, attended by 141,000 people.
“Nuance Audio blends cutting-edge audio software engineering, world-class smart eyewear design, and user-friendly technology to deliver a superior auditory experience,” EssilorLuxottica said.
Start-up delivering AI-based noise reduction
EssilorLuxottica announced on 2 January 2025 that it had acquired Pulse Audition, a French start-up delivering AI-based noise reduction and voice enhancement through algorithms allowing people with hearing impairment to better understand speech, even in noisy environments.
By integrating its proprietary technologies, expertise in AI software development, embedded AI, and audio signal processing, EssilorLuxottica said it would complement proprietary hardware and software to improve the quality of its products and solutions.
The buy aligns with the group’s strategy in the hearing solutions space, marking a natural evolution in the journey started in 2023 with the acquisition of Nuance Hearing, it said. Milleri and Mr Paul du Saillant, EssilorLuxottica deputy CEO, said it reinforced their commitment to advancing the next category of computing platforms.
In July 2023 the company, which has spent more than 60 years in eyewear, announced its plans to expand into hearing solutions by buying Nuance Hearing. EssilorLuxottica’s Super Audio Division comprising sound engineers and in-house R&D resources introduced the “integrated technology at the intersection of vision and sound”.
