FDA.report

Pure-tone audiometer

Definition
An electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.
GUDID devices
164
Last updated
2023-07-04 08:41:06

Related Product Codes

CodeDeviceSpecialtyClassDevices
EWOAudiometerEar, Nose, Throat288
IYEAccelerator, Linear, MedicalRadiology275
ETYTester, Auditory ImpedanceEar, Nose, Throat21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08059300420010OtoPad AMPLIFON SPA2.02023-06-26
05713315009969Bone Conductor (BC-2)Gn Otometrics A/S0415452023-03-09
05713315010101Bone Conductor (BC-2)Gn Otometrics A/S0415462023-03-09
00810046701690Grason-StadlerDiagnostic Group LLCGSI AMTAS Flex2023-03-07
00810044583045MedRxMEDRX, INC.MedRx AWRC2022-09-01
04260176127444MaicoMAICO Diagnostics GmbHMA 422022-06-15
04260176129431MaicoMAICO Diagnostics GmbHeasyTone2022-06-15
00810044582963MedRxMEDRX, INC.MedRx Kiosk2022-02-25
04260176127628BensonMAICO Diagnostics GmbHCCA-100 Mini Audiometer2021-02-15
04260176127635BensonMAICO Diagnostics GmbHCCF-200 Fit Test2021-02-15
04260176127659BensonMAICO Diagnostics GmbHCCA-200 Mini Audiometer2021-02-15
04260176127666BensonMAICO Diagnostics GmbHCCA-200 Mini 2021-02-15
04260176127673BensonMAICO Diagnostics GmbHCCA-200 Mini Audiometer2021-02-15
04260176127697BensonMAICO Diagnostics GmbHCCA-100 Mini Audiometer2021-02-15
04260176127703BensonMAICO Diagnostics GmbHCCA-100 Mini Audiometer2021-02-15
04260176127727BensonMAICO Diagnostics GmbHNEXT Audiometer2021-02-15
04260176127734BensonMAICO Diagnostics GmbHCCF-200 Fit Tester2021-02-15
04260176127741BensonMAICO Diagnostics GmbHCCF-200 Fit Tester2021-02-15
00860005068302WAHTSEdare LLCAC 12021-01-31
05713315008603Natus Gn Otometrics A/S8-31-1902020-12-16
05713315008610Natus Gn Otometrics A/S8-31-2002020-12-16
05713315008627Natus Gn Otometrics A/S8-31-190022020-12-16
04260176127369TREMETRICSMAICO Diagnostics GmbHRA3602020-07-08
04260223145285Senti Desktop FlexPATH medical GmbH100470-SC2020-06-27
00860003469811hearXHEARX GROUP (PTY) LTDhearTest2020-05-04
04260176120377MaicoMAICO Diagnostics GmbHMA 252020-04-17
04260176120704MaicoMAICO Diagnostics GmbHMA 412020-04-17
04260176120858MaicoMAICO Diagnostics GmbHMA 12020-04-17
04260176120865MaicoMAICO Diagnostics GmbHMA 272020-04-17
04260176120902MaicoMAICO Diagnostics GmbHMA 422020-04-17
04260176121961MaicoMAICO Diagnostics GmbHMA 332020-04-17
04260176126935MaicoMAICO Diagnostics GmbHPilot Test2020-04-17
05713557000014OscillaInmedico A/SSM9102016-09-21
05713557000021OscillaInmedico A/SSM910-B2016-09-21
05713557000045OscillaInmedico A/SSM9302016-09-21
05713557000052OscillaInmedico A/SSM9502016-09-21
05713557000069OscillaInmedico A/SSM950-S2016-09-21
05713557000076OscillaInmedico A/SSM960-C2016-09-21
08054187380778TRIANGLEINVENTIS SRLTRIANGLE2020-03-06
00810044580006MedRxMEDRX, INC.Avant A2D+2016-09-24
00810044580013MedRxMEDRX, INC.Avant ARC2016-09-24
00810044580044MedRxMEDRX, INC.Avant Stealth Audiometer2016-09-24
00810044580082MedRxMEDRX, INC.Tinnometer2017-08-28
00810044580112MedRxMEDRX, INC.Avant AIR+ 2017-12-12
04260223142505Senti DesktopPATH medical GmbH1004332020-01-20
04260223142987Senti Desktop Flex (Basic Set)PATH medical GmbH1004702020-01-20
57135570000025OscillaInmedico A/SSM910-B2016-09-21
57135570000049OscillaInmedico A/SSM9302016-09-21
57135570000056OscillaInmedico A/SSM9502016-09-21
57135570000063OscillaInmedico A/SSM950-S2016-09-21
57135570000070OscillaInmedico A/SSM960-C2016-09-21
06009900487816KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Prime2019-05-02
06009900487823KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Plus2019-05-02
06009900487830KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Pro2019-05-02
06009900487847KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Prime TMP2019-05-02
06009900487854KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Plus TMP2019-05-02
06009900487861KUDUwaveEMOYODOTNETZA (PTY) LTDKUDUwave Pro TMP2019-05-02
57135570000001OscillaInmedico A/SSM9102016-09-21
57135570000002OscillaInmedico A/SSM910-B2016-09-21
57135570000004OscillaInmedico A/SSM9302016-09-21
57135570000005OscillaInmedico A/SSM9502016-09-21
57135570000006OscillaInmedico A/SSM950-S2016-09-21
57135570000007OscillaInmedico A/SSM960-C2016-09-21
B348SHOEBOXAUDIOMETER0SHOEBOX AUDIOMETRYSHOEBOX LtdSHOEBOXAUDIOMETER2016-09-20
04260176121114MaicoMAICO Diagnostics GmbHMA 282017-07-27
04260176121190MaicoMAICO Diagnostics GmbHRA6602017-07-27
04260223142529SentiPATH medical GmbH1000972018-05-14
04260223142963Senti Set 2PATH medical GmbH1004502018-05-14
04260223142970Senti Set 3PATH medical GmbH1004602018-05-14
04260223143151Senti Set 1PATH medical GmbH1003302018-05-14
05060488901027AmplivoxAMPLIVOX LIMITEDModel 2602016-09-24
05060488901034AmplivoxAMPLIVOX LIMITEDModel 2402016-09-24
05060488901102AmplivoxAMPLIVOX LIMITEDModel 2702016-09-24
05060488901164AmplivoxAMPLIVOX LIMITEDModel 1702016-09-24
05060488901171AmplivoxAMPLIVOX LIMITEDModel 1162016-10-06
05420028702178Orfit IndustriesOrfit Industries NV600032018-05-08
05420028702758Orfit IndustriesOrfit Industries NV35779/2MI/EM2018-05-08
05420028703205Orfit IndustriesOrfit Industries NV35799/2MI/R2018-05-08
05420028703229Orfit IndustriesOrfit Industries NV35799/2MI/L2018-05-08
05420028703335Orfit IndustriesOrfit Industries NV600982018-05-08