Nuheara Gets FDA Approval of OTC Hearing Aid

Nuheara has gained FDA clearance for its HP Hearing Pro, meeting both FDA Class II and OTC requirements for hearing aids in a wireless ear bud design.

The company has a worldwide licensing agreement with Hewlett Packard to market the device as HP Hearing PRO and plans to sell it in Best Buy stores and on amazon.com at an expected price of $699.

The device has been clinically proven to be substantially equivalent to a professionally fit hearing aid, the company said. To calibrate the device, users must first download the HP Hearing application onto an iOS or Android phone or tablet and connect the app to the hearing device. The app will then test the wearer’s individual hearing thresholds from low frequency to high frequency in each ear and adjust the device’s sound levels.