EssilorLuxottica Receives FDA Clearance for Nuance Audio Smart Glasses
Conexiant
February 3, 2025
EssilorLuxottica received FDA clearance and CE marking for its Nuance Audio Glasses, enabling market launch in the U.S. and EU.
The Nuance Audio Glasses integrate hearing aid functionality into smart glasses, providing vision and hearing support.
These glasses target individuals with mild to moderate hearing loss, affecting an estimated 1.25 billion people globally.
They are the first FDA-cleared preset Software as a Medical Device hearing aid in the U.S., offering an open-ear solution.
Sales in the U.S. are expected to begin in Q1, with a gradual rollout in Europe starting with Italy in Q1 2025.
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