Nuheara IQbuds 2 PRO Hearing Aid

Nuheara IQbuds 2 PRO Hearing Aid is an FDA 510(k)-cleared medical device (K221064) manufactured by Nuheara Limited. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2022. Regulation: 8.