EssilorLuxottica’s Nuance Audio Glasses have received FDA approval for over-the-counter sales in the U.S.,

 

 

EssilorLuxottica’s Nuance Audio Glasses have received FDA approval for over-the-counter sales in the U.S., marking a major step in merging hearing and vision technology. With CE certification under the EU’s Medical Devices Regulation, a European launch is set for 2025, starting with Italy, France, Germany, and the UK.

 

These smart glasses blend eyewear with open-ear audio technology, offering a stylish and discreet hearing solution. As the first software-as-a-medical-device (SaMD) to get FDA approval, they tackle challenges like social stigma, comfort, and aesthetics, which have slowed hearing aid adoption.

 

With 1.25 billion people worldwide facing mild to moderate hearing loss, EssilorLuxottica plans to leverage its retail and audiology network to expand availability. This innovation signals a shift toward integrated health solutions, with the industry watching closely to see its impact.