
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing solutions with prescription lenses.
According to a 3 February press release, EssilorLuxottica received simultaneous clearance from the US Food and Drug Administration (FDA) and CE marking from the European Commission (EC) for Nuance.
Based in France, the company is the biggest manufacturer of ophthalmic lenses and eyeglasses in the world and the owner of brands such as Ray-Ban.
According to EssilorLuxottica, the software housed in the glasses – called Nuance Audio Hearing Aid Software – is the first FDA-cleared, preset Software as Medical Device (SaMD) in the US. The glasses will launch in the US at the beginning of Q1 2025, with the European rollout expected to begin in the first half of 2025. The company said it would use its retail network to distribute the glasses, along with engaging both traditional audiology practices and optical wholesale customers.
EssilorLuxottica’s venture into the hearing loss market started with the acquisition of Nuance Hearing in 2023. The company has integrated the audio component into the glasses in a “completely invisible” manner, which it says will help remove a psychological barrier devices such as hearing aids have. Nuance uses speakers embedded in the frame near the ears to amplify sounds around the user.
EssilorLuxottica’s CEO Francesco Milleri said: “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.
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By GlobalData“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 company bolstered its audio platform after acquiring French startup Pulse Audition last month. Pulse Audition had developed AI-based speech enhancement software.
EssilorLuxottica is targeting the 1.25 billion people around the world who experience mild to moderate hearing loss. Traditionally, hearing aids have been the devices used to treat patients who are hard of hearing. While OTC hearing aids have helped improve accessibility, the stigma around the visibility of hearing aids remains.
Research published by the UK’s Royal National Institute for Deaf People (RNID) in September 2024 demonstrates that public perceptions of hearing aids are important in using the devices. In a poll of 2,768 members of the public, the RNID found that more than one in three people would try to hide hearing aids if they needed them.
A significant moment in the space came courtesy of tech giant Apple when it gained FDA clearance for its hearing aid software to be used in its earphone product Airpods, designed usually to listen to music and podcasts. Similar to Apple, EssilorLuxottica is combining hearing solutions into an everyday piece of technology – an approach that analysts predict will transform hearing loss treatment.