FDA.report

Impedance audiometer

Definition
An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.
GUDID devices
168
Last updated
2025-09-09 19:02:55

Related Product Codes

CodeDeviceSpecialtyClassDevices
ETYTester, Auditory ImpedanceEar, Nose, Throat2147
EWOAudiometerEar, Nose, Throat215
PTOTester, Auditory Impedance, ExemptEar, Nose, Throat26
PTPTympanometer, ExemptEar, Nose, Throat22
NASTympanometerEar, Nose, Throat21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08051597160099ResonanceM.R.S. SRLR16M2025-09-01
05713315009389Madsen ZodiacNatus Medical Denmark ApS0364332022-12-12
05713315009396Madsen ZodiacNatus Medical Denmark ApS0364342022-12-15
05713315009907Madsen ZodiacNatus Medical Denmark ApS8-35-100012022-12-15
05713315009914Madsen ZodiacNatus Medical Denmark ApS8-35-100022022-12-15
00732094140637Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-23
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094084795Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094085006Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094085013Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
00732094085020Welch Allyn, Inc.WELCH ALLYN, INC.9010012023-08-17
08054187380419VIOLAINVENTIS SRLVIOLA BASIC WITH PRINTER2016-09-17
08054187380433VIOLAINVENTIS SRLVIOLA PLUS WITH PRINTER2016-09-17
05713315009464Madsen ZodiacGn Otometrics A/S8-04-163072022-12-05
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLTIMPANI DOCKING STATION2023-01-04
00571331500946Madsen ZodiacGn Otometrics A/S8-04-163072022-12-05
05713315009419Madsen ZodiacGn Otometrics A/S8-04-163022022-12-05
05713315009440Madsen ZodiacGn Otometrics A/S8-04-163052022-12-05
05713315009495Madsen ZodiacGn Otometrics A/S8-04-163102022-12-05
05713315009563Madsen ZodiacGn Otometrics A/S8-04-163172022-12-05
05713315009648Madsen ZodiacGn Otometrics A/S8-04-163252022-12-05
05713315009723Madsen ZodiacGn Otometrics A/S8-04-163332022-12-05
05713315009778Madsen ZodiacGn Otometrics A/S8-04-163382022-12-05
05713315009846Madsen ZodiacGn Otometrics A/S8-04-163452022-12-05
00860007953705Wavely Ear TipWavely Diagnostics, Inc.1300-052022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.SWA-12622022-08-08
05713315009013MadsenGn Otometrics A/S1012 OTOflex Cavity set2021-08-11
05711117180282InteracousticsInteracoustics A/SMT102021-06-03
00732094012651Welch Allyn, Inc.WELCH ALLYN, INC.9010352021-05-07
00732094300642Welch Allyn, Inc.WELCH ALLYN, INC.9010332021-05-06
00732094300659Welch Allyn, Inc.WELCH ALLYN, INC.9010332021-05-06
00732094301069Welch Allyn, Inc.WELCH ALLYN, INC.9010332021-05-05
00732094083798Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
04260176120834MaicoMAICO Diagnostics GmbHeasyTymp2020-04-17
00732094085037Welch Allyn, Inc.WELCH ALLYN, INC.9010352019-09-03
04260223143694nanoTympPATH medical GmbH1009482020-01-31
04260223143731nanoTymp SetPATH medical GmbH100948-SET2020-01-31
05713315002267GN Otometrics A/S Gn Otometrics A/SAdult headset with TDH, HL calibration: HL2019-04-24
05713315002274GN Otometrics A/S Gn Otometrics A/SAdult headset with TDH, SPL calibration: SPL2019-04-24
05713315002281GN Otometrics A/S Gn Otometrics A/SAdult probeset with contra insert, insert earphone2019-04-24
05713315002298GN Otometrics A/S Gn Otometrics A/SAdult probeset with contra insert, insert earphone2019-04-24
05713315002311GN Otometrics A/S Gn Otometrics A/SAdult IPSI probeset, SPL. Calibration: SPL2019-04-24
05713315008252GN Otometrics A/SGn Otometrics A/SInsert Earphone Tube Tips2019-04-24
05713315002304OtometricsGn Otometrics A/SAdult IPSI probeset, HL. Calibration: HL2019-04-23
08054187380747TIMPANIINVENTIS SRLTIMPANI2019-04-16
04260176121046Maico DEMAICO Diagnostics GmbHtouchTymp2016-12-23
05060488901003AmplivoxAMPLIVOX LIMITEDOtowave 2022016-09-24
05060488901010AmplivoxAMPLIVOX LIMITEDOtowave 1022016-09-24
05060488901386AmplivoxAMPLIVOX LIMITEDOtowave 3022017-08-08
05711117180251InteracousticsInteracoustics A/SAT2352016-10-27
05713315001635GN Otometrics A/SGn Otometrics A/S"MADSEN OTOflex 100 Diagnostic2016-09-17
05713315001642GN Otometrics A/SGn Otometrics A/S"MADSEN OTOflex 100 Quick Check2016-09-17
05713315001666GN Otometrics A/SGn Otometrics A/S"Infant eartips (50 pcs.)2016-09-17
05713315001673GN Otometrics A/SGn Otometrics A/S"Infant eartips (50 pcs.)2016-09-17
05713315001680GN Otometrics A/SGn Otometrics A/S"Infant eartips (50 pcs.)2016-09-17
05713315001697GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001703GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001710GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001727GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001734GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001741GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001758GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001765GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001772GN Otometrics A/SGn Otometrics A/S"Regular eartips (50 pcs.)2016-09-17
05713315001789GN Otometrics A/SGn Otometrics A/S"Screening eartips (50 pcs.)2016-09-17
05713315001796GN Otometrics A/SGn Otometrics A/S"Screening eartips (50 pcs.)2016-09-17
05713315001802GN Otometrics A/SGn Otometrics A/S"Screening eartips (50 pcs.)2016-09-17
05713315001819GN Otometrics A/SGn Otometrics A/S"Screening eartips (50 pcs.)2016-09-17
05713315001826GN Otometrics A/SGn Otometrics A/S"Screening eartips (50 pcs.)2016-09-17
05713315001833GN Otometrics A/SGn Otometrics A/SEartip Box, Large2016-09-17
05713315001840GN Otometrics A/SGn Otometrics A/S"Shoulder Harness2016-09-17
05713315001864GN Otometrics A/SGn Otometrics A/S"Immittance Probe Complete 2016-09-17
05713315001871GN Otometrics A/SGn Otometrics A/S"Probe Tip Kit 2016-09-17
05713315001888GN Otometrics A/SGn Otometrics A/S"Probe Tip Kit2016-09-17