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EssilorLuxottica ‘hearing glasses’ Nuance Audio receive FDA approval and EU certifications

by Rob Mitchell
February 4, 2025
in Artificial Intelligence, Business, Company updates & acquisitions, International, News, Smart glasses
Reading Time: 3 mins read
A A
The glasses have a number of microphones built into the frames. Image: Nuance Audio.

The glasses have a number of microphones built into the frames. Image: Nuance Audio.

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EssilorLuxottica’s Nuance Audio Glasses – spectacles incorporating hearing aids – have received approval for use and sale in the US and European markets, with plans to make them available in its own retail network, to traditional audiology practices and optical wholesale customers.

The company is marketing its Nuance Audio Glasses as a “breakthrough 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.

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.

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.

More reading

Nuance Audio glasses create plenty of buzz at CES tech show

EssilorLuxottica to acquire EyeQ Optometrists

EssilorLuxottica reveals Nuance Audio integrating open-ear hearing technology into eyewear

 

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