RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION is an FDA 510(k)-cleared medical device (K971605) manufactured by Resound Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 2, 1997. Regulation: 8.