Cochlear confirms FDA clearance for Osia 2 System

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Cochlear (ASX:COH) has announced it has received FDA clearance for its Osia 2 System. The system is indicated and approved in the US for adults and children (12 years and older) with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness.

The Osia 2 System is the world’s first active osseointegrated steady-state implant, using digital piezoelectric stimulation to bypass damaged areas of the natural hearing system and send sound vibrations directly to the cochlea.

Cochlear said it will commence the commercial rollout of the system in the US during the second half of FY20, with availability in other countries subject to regulatory approvals.