Nuance Audio hearing aid glasses receive concurrent CE Mark and FDA approval

Nuance Audio pairs directional microphones with open-ear speakers. Image courtesy of EssilorLuxottica

EssilorLuxottica has received a CE Mark under the Medical Devices Regulation of the European Medicines Agency for its Nuance Audio Glasses, which integrate open-ear hearing aids into a pair of smart glasses. Concurrently, the device received The over-the-counter device received an ISO Quality Management System certification for Hearing Aids. The CE Mark was issued concurrently with medical device approval from the US Food and Drug Administration. The sweep of approvals will allow the glasses to launch in the US and Europe simultaneously.¹

“Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear," Francesco Milleri, Chairman and CEO of EssilorLuxottica, said in a press release. "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."

Nuance Audio Hearing Aid Software is the first Software as Medical Device (SaMD) to received FDA clearance in the US. The smart glasses combine stylish frames with an open-ear hearing aid, which reduces crowding around the ear that happens when using both a hearing aid and 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 press release reads.

Following the CE marking, Nuance Audio Glasses will be available in Italy in Q1 2025, then will expand to include France, Germany, UK, and additional unnamed European markets progressively over the first half of 2025. In the US, Nuance Audio Glasses will be available for over-the-counter purchase in Q1 2025 in the US.

According to the press release, EssilorLuxottica’s aim in creating Nuance Audio was to tackle hearing device disuse due to stigma, discomfort, cost, and limited accessibility. According to the World Health Organization’s 2021 World Report on Hearing, approximately 1.25 billion people worldwide experience mild to moderate hearing loss.² With the introduction of Nuance Audio, EssilorLuxottica hopes to encourage more widespread adoption of hearing aids without sacrificing visual acuity.

References

1. EssilorLuxottica receives FDA clearance and EU certifications for Nuance Audio, making it available to consumers in the U.S. and Europe. EssilorLuxottica. Press release. Published February 3, 2025. Accessed February 3, 2025. https://www.essilorluxottica.com/en/newsroom/press-releases/fda-clearance-and-eu-certifications-for-nuance-audio/

2. World Health Organization, World Report on Hearing, 2021, p. 40.