EWO
AUDIOMETER
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 235
Adverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code EWO
1–100 of 235- K234095 — OtoNova/OtoNova Pro
- K240430 — Otoport Pro
- K231545 — hearOAE
- K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
- K191372 — Lyra
- K180287 — GSI Corti
- K173567 — Sera
- K172403 — GSI Novus
- K171506 — Easyscreen
- K151025 — iHearTest
- K150491 — ER36 Series OAE Test System
- K141524 — NEURO-AUDIO
- K143395 — Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
- K133012 — SENTIERO
- K130795 — TITAN
- K123624 — OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
- K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
- K121512 — SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
- K112992 — EARLOGIC OAE TESTER
- K112247 — A BAER WITH ABAER I/O FUNCTION
- K111618 — AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
- K112733 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM
- K103298 — ACAM 5 AUDIOMETER SYSTEM
- K092089 — CLARUJUST
- K092244 — MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
- K092111 — ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
- K090406 — EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
- K081234 — GN OTOMETRICS INSERT EARPHONES
- K072033 — OTODYNAMICS OTOPORT
- K070880 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM
- K063452 — MA 55 MAESTRO
- K070118 — OTOGRAM, CA3350
- K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
- K061744 — COCHLEA-SCAN / COCHLEA-SCAN PLUS
- K060883 — PILOT TEST OR DETECTIVE AUDIOMETERS
- K060885 — MODEL MI 44 TYMPANOMETER
- K060539 — DPOAE20 , ECLIPSE
- K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
- K052562 — ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
- K043219 — AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
- K033108 — VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
- K031713 — AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
- K031986 — ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
- K031352 — BIO-LOGIC INSERT EARPHONES
- K030016 — TEOAE25
- K024205 — AUDIOSCREENER OAE+ABR
- K023859 — SMARTTROAE
- K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
- K011135 — GSI AUDERA
- K003364 — VIVO 200 DPS VIVOSCAN
- K011114 — ETYMOTIC RESEARCH ER-10D OAE PROBE
- K011181 — ICS MEDICAL CHARTR OAE WITH TYMP
- K003913 — HINT AUDIOMETER, OR HINT
- K010165 — ERO SCAN OAE TEST SYSTEM
- K002200 — CAPELLA
- K001058 — AUDIOSCREENER OAE + ABR
- K994033 — HORTMANN ECHOMASTER OAE ANALYZER
- K000184 — AUDIOSCREENER OAE
- K984547 — DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
- K983915 — AMPLAID A315 AND A319
- K983851 — CAPELLA COCHLEAR EMISSIONS ANALYZER
- K983712 — AMPLAID A311 SERIES
- K983350 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983351 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983352 — ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
- K983048 — AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K982878 — EARSCAN 3
- K982723 — MAICO MA42
- K982566 — AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
- K982642 — ECHO-SCREEN
- K982441 — CCA-220
- K982249 — INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
- K981511 — OTO WIZZARD
- K981439 — CCA-200
- K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM
- K981327 — INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
- K981142 — MAICO MA53
- K980505 — HORTMANN AMDIS-OAE OAE ANALYZER
- K980533 — ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
- K973377 — SIBELMED AC50D
- K974237 — GSI 70 AUDIOPATH SCREENER
- K974076 — SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
- K973320 — ARTICULATE FITTING SYSTEM
- K972862 — AMPLAID 171S
- K972221 — K 15 AUDIOMETER
- K971747 — AMPLAID 460
- K971080 — MAICO MA52
- K964132 — MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
- K970279 — RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
- K970555 — IL0292 DP ECHOPORT
- K964426 — SMARTOAE
- K962995 — ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
- K964340 — PORTAREM-3000, PFS-6000
- K963681 — CCA-100 (MODIFIED)
- K962275 — MAICO MA25 SERIES II WITH SPEECH
- K962012 — ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
- K961447 — SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
- K953814 — OTOSCAPE
- K953684 — GSI 61 CLINICAL AUDIOMETER
- K953884 — PROPHET
Data sourced from openFDA. This site is unofficial and independent of the FDA.