FDA.reportPublic FDA data

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
207
Last updated
2026-06-13 06:05:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00571331500960Madsen ZodiacNatus Medical Denmark ApS8-04-163212026-06-04
05713315009587Madsen ZodiacNatus Medical Denmark ApS8-04-163192026-06-04
05713315009594Madsen ZodiacNatus Medical Denmark ApS8-04-163202026-06-04
05713315009624Madsen ZodiacNatus Medical Denmark ApS8-04-163232026-06-04
05713315009426Madsen ZodiacNatus Medical Denmark ApS8-04-163032026-06-03
05713315009433Madsen ZodiacNatus Medical Denmark ApS8-04-163042026-06-03
05713315009457Madsen ZodiacNatus Medical Denmark ApS8-04-163062026-06-03
05713315009471Madsen ZodiacNatus Medical Denmark ApS8-04-163082026-06-03
05713315009488Madsen ZodiacNatus Medical Denmark ApS8-04-163092026-06-03
05713315009501Madsen ZodiacNatus Medical Denmark ApS8-04-163112026-06-03
05713315009518Madsen ZodiacNatus Medical Denmark ApS8-04-163122026-06-03
05713315009525Madsen ZodiacNatus Medical Denmark ApS8-04-163132026-06-03
05713315009532Madsen ZodiacNatus Medical Denmark ApS8-04-163142026-06-03
05713315009556Madsen ZodiacNatus Medical Denmark ApS8-04-163162026-06-03
05713315009570Madsen ZodiacNatus Medical Denmark ApS8-04-163182026-06-03
05713315009402Madsen ZodiacNatus Medical Denmark ApS8-04-163012026-06-02
00732094011968Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-06-22
00810046700013Grason-StadlerDiagnostic Group LLCGSI 392016-09-24
00810046700044Grason-StadlerDiagnostic Group LLCGSI TympStar Pro2016-11-10
00810046700112Grason-StadlerDiagnostic Group LLCGSI Allegro2018-06-29
00860007953736WavelyDx Ear Tip - Pack of 3Wavely Diagnostics, Inc.1480-032026-04-03
00860007953767WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.SWA-14882026-04-03
00860007953774WavelyDx Ear Tip - Pack of 6Wavely Diagnostics, Inc.1480-062026-04-03
00860007953781WavelyDx Ear Tip - Pack of 2Wavely Diagnostics, Inc.1538-022026-04-03
05060488902673Amplivox AMPLIVOX LIMITEDOtowave 302 2024-01-08
08054187380259FLUTEINVENTIS SRLFLUTE BASIC2016-09-17
08054187380266FLUTEINVENTIS SRLFLUTE BASIC WITH PRINTER2016-09-17
08054187380273FLUTEINVENTIS SRLFLUTE PLUS2016-09-17
08054187380280FLUTEINVENTIS SRLFLUTE PLUS WITH PRINTER2016-09-17
08054187380440FLUTEINVENTIS SRLFLUTE HF2016-09-17
08054187380457FLUTEINVENTIS SRLFLUTE HF WITH PRINTER2016-09-17
08054187380464CLARINETINVENTIS SRLCLARINET BASIC2016-09-17
08054187380471CLARINETINVENTIS SRLCLARINET BASIC WITH PRINTER2016-09-17
08054187380488CLARINETINVENTIS SRLCLARINET PLUS2016-09-17
08054187380495CLARINETINVENTIS SRLCLARINET PLUS WITH PRINTER2016-09-17
08054187381232easyTympINVENTIS SRLeasyTymp2026-04-23
08054187381249easyTymp Docking StationINVENTIS SRLeasyTymp Docking Station2026-04-23
08584270041663MaicoDiagnostic Group LLCeasyTymp2016-09-24
08584270041670MaicoDiagnostic Group LLCeasyTymp Pro Version2016-11-10
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 ZodiacNatus Medical Denmark ApS8-04-163072022-12-05
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLTIMPANI DOCKING STATION2023-01-04
00571331500946Madsen ZodiacGn Otometrics A/S8-04-163072022-12-05
05713315009419Madsen ZodiacNatus Medical Denmark ApS8-04-163022022-12-05
05713315009440Madsen ZodiacNatus Medical Denmark ApS8-04-163052022-12-05
05713315009495Madsen ZodiacNatus Medical Denmark ApS8-04-163102022-12-05
05713315009563Madsen ZodiacNatus Medical Denmark ApS8-04-163172022-12-05
05713315009648Madsen ZodiacNatus Medical Denmark ApS8-04-163252022-12-05
05713315009723Madsen ZodiacNatus Medical Denmark ApS8-04-163332022-12-05
05713315009778Madsen ZodiacNatus Medical Denmark ApS8-04-163382022-12-05
05713315009846Madsen ZodiacNatus Medical Denmark ApS8-04-163452022-12-05
00860007953705Wavely Ear TipWavely Diagnostics, Inc.1300-052022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.SWA-12622022-08-08
05713315009013MadsenNatus Medical Denmark ApS1012 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