DAIL A HEARING SCREENING TEST

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OLYMPUS B5-2C/B7-2C BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FISCH TITANIUM MIDDLE EAR PROSTHESES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GN OTOMETRICS TYPE 1053 FREEFIT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVIS 200 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SOLACE SOUND GENERATORS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENT ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VENTILATION TUBES WITH HYDROGEL COATING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ion Endoluminal System (IF1000)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BHA100 Series Braun Clear Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WSA Self-Fitting Hearing Aid Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOTESTER SCREENING AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat