Cleared for sale in the US

  • FDA 510(k) clearance received July 18, 2014

  • Includes software, ear buds and Apple® mobile digital devices

  • Among the first to clear Apple® hardware as a medical device

Cleared for sale in the EU and Canada

  • CE Mark received March 24, 2014

  • Licensed by Health Canada

Entire system is CSA Certified

  • Includes software, hardware & Apple® mobile digital devices

  • IEEE Third Edition Medical Device Electrical Safety 60601-1-1

ISO 13485 2016 edition, for the design and manufacture of medical devices

  • Otoharmonics is ISO 13485 Certified

  • All development was done under ISO 13485 standards