
Widex USA
Free shipping on orders over $99 · 30-day returns
IE-ZEN (IN CLEAR SERIES HEARING AID) is an FDA 510(k)-cleared medical device (K110973) manufactured by Widex USA. 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 May 4, 2011. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

Ohmeda Medical
SKU K871399

Insulet Corporation
SKU K182630