EssilorLuxottica's Nuance Audio Glasses Receive FDA Clearance and EU Certifications
EssilorLuxottica announced on February 3, 2025, that its Nuance Audio smart glasses software has received FDA clearance in the U.S. and CE marking in the EU, paving the way for consumer availability.
EssilorLuxottica announced on February 3, 2025, the receipt of clearance from the U.S. Food and Drug Administration (FDA) for its OTC Nuance Audio glasses software. The company also achieved the CE marking under the EU's Medical Devices Regulation and developed an ISO Quality Management System certification for Hearing Aids, enabling the product's launch in Europe.
The Nuance Audio solution integrates hearing assistance into smart glasses for an open-ear experience. It is described as the first FDA-cleared, preset Software as a Medical Device (SaMD) in the U.S. The product aims to address barriers such as stigma, comfort, and aesthetics that have historically hindered the adoption of traditional hearing aids.
Nuance Audio glasses are scheduled for release in the U.S. in the first quarter of 2025. European availability will commence progressively in the first half of 2025, starting in Italy during Q1, followed by launches in France, Germany, and the UK.
The company intends to leverage its extensive retail network and collaborate with audiology practices and optical wholesale customers to distribute the product. This initiative targets the estimated 1.25 billion people worldwide experiencing mild to moderate hearing loss.