FDA.reportPublic FDA data

Tone audiometer, semi-automated

Definition
An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.
GUDID devices
103
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05407004250038Jacoti Hearing Center ProJacotiJacoti Hearing Center Pro 1.X2023-01-09
00860007826634Salux™Examinetics, Inc.SALUX-AU-022023-05-09
00860007826641Salux™Examinetics, Inc.SALUX-SW-022023-05-09
00860007826603Salux™Examinetics, Inc.SALUX-AU-012022-01-27
00860007826610Salux™Examinetics, Inc.SALUX-HP-012022-01-27
00860007826627Salux™Examinetics, Inc.SALUX-SW-012022-01-27
05713315009204MadsenNatus Medical Denmark ApS8-04-13102-CA2021-07-01
05713315009211AuricalNatus Medical Denmark ApS8-04-14530-CA2021-07-01
05713315009228MadsenNatus Medical Denmark ApS8-04-14562-CA2021-07-01
05713315002441GN Otometrics A/SNatus Medical Denmark ApSTDH 39 with cushion (contralateral earphone)2019-10-08
05713315002182GN Otometrics A/SNatus Medical Denmark ApSEartip ZO901, 10mm, 50 pcs 2019-04-08
05713315002199GN Otometrics A/SNatus Medical Denmark ApSEartip ZO901, 13mm, 50 pcs2019-04-08
05713315002205GN Otometrics A/SNatus Medical Denmark ApSEartip ZO901, 16mm, 50 pcs2019-04-08
05713315002212GN Otometrics A/SNatus Medical Denmark ApSEartip ZO901, 19mm, 50 pcs2019-04-08
05713315002229GN Otometrics A/SNatus Medical Denmark ApSEartip ZO901, 22mm, 50 pcs2019-04-08
05713315000577GN Otometrics A/SNatus Medical Denmark ApSMADSEN Astera 2, US Only2016-09-19
05713315000584GN Otometrics A/SNatus Medical Denmark ApSMADSEN Astera 2, W/O HDA, US Only2016-09-19
05713315000591GN Otometrics A/SNatus Medical Denmark ApSEartip, Earlink 3A, standard2016-09-17
05713315000607GN Otometrics A/SNatus Medical Denmark ApSEartip, Earlink 3B, small2016-09-17
05713315000614GN Otometrics A/SNatus Medical Denmark ApS Eartip, Earlink 3C, jumbo2016-09-17
05713315000621GN Otometrics A/SNatus Medical Denmark ApSHeadset Monitoring2016-09-19
05713315000638GN Otometrics A/SNatus Medical Denmark ApSHeadset ME70 (12 kHz) matched2016-09-19
05713315000645GN Otometrics A/SNatus Medical Denmark ApSBone Conductor w/ headband and cable2016-09-17
05713315000652GN Otometrics A/SNatus Medical Denmark ApSMonitor Headset w/cable2016-09-19
05713315000669GN Otometrics A/SNatus Medical Denmark ApSHeadset ME70 (12 kHz) matched2016-09-19
05713315000676GN Otometrics A/SNatus Medical Denmark ApS Insert Phone Stereo (10 ohm)2016-09-19
05713315000683GN Otometrics A/SNatus Medical Denmark ApS TO/TB Sound Tube2016-09-19
05713315000690GN Otometrics A/SNatus Medical Denmark ApS Headset HDA 3002016-09-19
05713315000706GN Otometrics A/SNatus Medical Denmark ApS Microphone w/ table stand (jack)2016-09-19
05713315000720GN Otometrics A/SNatus Medical Denmark ApSPatient Responder (Blue)2016-09-19
05713315000737GN Otometrics A/SNatus Medical Denmark ApSPatient Responder (Grey)2016-09-17
05713315000805GN Otometrics A/SNatus Medical Denmark ApSMonitor Speaker Kit2016-09-19
05713315000911GN Otometrics A/SNatus Medical Denmark ApSHeadphone (customer)2016-09-17
05713315001031GN Otometrics A/SNatus Medical Denmark ApSREM Tube, Blue Handle (50 pcs.)2016-09-17
05713315001048GN Otometrics A/SNatus Medical Denmark ApSEAR tone, Tube Niples2016-09-17
05713315001291GN Otometrics A/SNatus Medical Denmark ApSMADSEN Capella2, TE2016-09-19
05713315001314GN Otometrics A/SNatus Medical Denmark ApSOAE Test Cavity2016-09-19
05713315001321GN Otometrics A/SNatus Medical Denmark ApS Eartip 3-6mm Yellow, 100 Pcs.2016-09-19
05713315001338GN Otometrics A/SNatus Medical Denmark ApS Eartip 4mm Red, 100 Pcs.2016-09-19
05713315001345GN Otometrics A/SNatus Medical Denmark ApSEartip 5mm Blue, 100 Pcs2016-09-19
05713315001352GN Otometrics A/SNatus Medical Denmark ApSEartip 6mm Green, 100 Pcs.2016-09-19
05713315001369GN Otometrics A/SNatus Medical Denmark ApSEartip 7mm Yellow, 100 Pcs.2016-09-19
05713315001376GN Otometrics A/SNatus Medical Denmark ApSEartip 8mm Red, 100 Pcs2016-09-19
05713315001383GN Otometrics A/SNatus Medical Denmark ApS Eartip 9mm Blue, 100 Pcs.2016-09-19
05713315001390GN Otometrics A/SNatus Medical Denmark ApS Eartip 10mm Green, 100 Pcs.2016-09-19
05713315001406GN Otometrics A/SNatus Medical Denmark ApSEartip 14mm Foam, 50 Pcs.2016-09-19
05713315001413GN Otometrics A/SNatus Medical Denmark ApSStarter Kit2016-09-19
05713315001420GN Otometrics A/SNatus Medical Denmark ApSProbe Cleaning Tool2016-09-19
05713315001437GN Otometrics A/SNatus Medical Denmark ApSProbe Cover Tip 4 Pcs.2016-09-19
05713315001444GN Otometrics A/SNatus Medical Denmark ApS Etymotics 10D OAE Probe2016-09-19
05713315001468GN Otometrics A/SNatus Medical Denmark ApSTest Cavity Seal, White2016-09-19
05713315001499GN Otometrics A/SNatus Medical Denmark ApSMADSEN Itera II, US Only2016-09-17
05713315001505GN Otometrics A/SNatus Medical Denmark ApSMADSEN Itera II, US Only2016-09-17
05713315001512GN Otometrics A/SNatus Medical Denmark ApSMADSEN Itera II, US Only2016-09-17
05713315001529GN Otometrics A/SNatus Medical Denmark ApS Headset Monitoring w/ boom mic2016-09-17
05713315001536GN Otometrics A/SNatus Medical Denmark ApS Accessory Kit for sound box installation (US)2016-09-17
05713315001543GN Otometrics A/SNatus Medical Denmark ApSStereo Microphone Kit2016-09-17
05713315001550GN Otometrics A/SNatus Medical Denmark ApSMicrophone, w. table stand ''jack''2016-09-17
05713315002090GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 6MM 50PCS2016-09-19
05713315002106GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 7MM 50PCS2016-09-19
05713315002113GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 8MM 50PCS2016-09-19
05713315002120GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 9.5MM 50PCS2016-09-19
05713315002137GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 11MM 50PCS2016-09-19
05713315002144GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,12,5MM 50PCS2016-09-19
05713315002151GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,14 MM 50PCS2016-09-19
05713315002168GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,16 MM 50PCS2016-09-19
05713315002175GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,18 MM 50PCS2016-09-19
05713315003318GN Otometrics A/SNatus Medical Denmark ApSREM Tube, Blue Handle (50 pcs.)2018-09-05
05713315003325GN Otometrics A/SNatus Medical Denmark ApSSILICONE TUBES, 50 PCS2016-09-19
05713315003660GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 6MM 50PCS2018-07-31
05713315003677GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 7MM 50PCS2018-07-31
05713315003684GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 8MM 50PCS2018-07-31
05713315003691GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 9.5MM 50PCS2018-07-31
05713315003707GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT, 11MM 50PCS2018-07-31
05713315003714GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,12,5MM 50PCS2018-07-31
05713315003721GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,14 MM 50PCS2018-07-31
05713315003738GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,16 MM 50PCS2018-07-31
05713315003745GN Otometrics A/SNatus Medical Denmark ApS1022, EAR TIP KIT,18 MM 50PCS2018-07-31
05713315004001GN Otometrics A/SNatus Medical Denmark ApS"""MADSEN XETA, US Only"2016-09-17
05713315004032GN Otometrics A/SNatus Medical Denmark ApSPatient Signal Switch (grey)2016-09-17