EssilorLuxottica’s Nuance Audio receives FDA clearance

EssilorLuxottica has secured clearance from the Food and Drug Administration for its over-the-counter Nuance Audio glasses, alongside CE marking under the Medical Devices Regulation in the EU.

In addition, the group has developed an ISO Quality Management System certification specifically for hearing aids, paving the way for the product’s European launch.

‘Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear,’ said Francesco Milleri, chairman and CEO of EssilorLuxottica.

‘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 was the first FDA-cleared, preset Software as Medical Device (SaMD) in the US, offering an open-ear hearing solution integrated into a pair of smart glasses.