FDA.report

Tone audiometer

Definition
An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.
GUDID devices
63
Last updated
2026-06-03 19:15:27

Related Product Codes

CodeDeviceSpecialtyClassDevices
EWOAudiometerEar, Nose, Throat258
PTOTester, Auditory Impedance, ExemptEar, Nose, Throat22
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat11
ETYTester, Auditory ImpedanceEar, Nose, Throat21
GWJStimulator, Auditory, Evoked ResponseNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B43061000060GoCheck Audiometric Headphone AssemblyGobiquity, Inc.Sennheiser HD280 Pro2024-09-23
B43056000011110GoCheckGobiquity, Inc.Hearing Mobile App V1.1.12026-01-09
B43056000011100GoCheckGobiquity, Inc.Hearing Mobile App V1.1.02025-12-02
08051597160051ResonanceM.R.S. SRLR15C2025-09-01
04260223147326nanoAudio DD45PATH medical GmbH101414-012025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbH101414-022025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbH1014202025-08-05
04260223147449nanoAudio DD45 SetPATH medical GmbH101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response ButtonPATH medical GmbH101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-WestlakePATH medical GmbH101470-032025-08-05
04260223147470nanoAudio DD65v2 SetPATH medical GmbH101470-042025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response ButtonPATH medical GmbH101470-052025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-WestlakePATH medical GmbH101470-062025-08-05
B43056000011000GoCheckGobiquity, Inc.Hearing Mobile App V1.0.02024-09-23
00860005068319Audhere SoftwareEdare LLC0.X.X2024-04-18
04260176128311BensonMAICO Diagnostics GmbHNEXT Audiometer2021-02-15
00810046700006Grason-StadlerDiagnostic Group LLCGSI 182016-11-10
00810046700075Grason-StadlerDiagnostic Group LLCGSI Pello2016-11-28
00810046700129Grason-StadlerDiagnostic Group LLCGSI Novus2017-10-24
00810046700235Grason-StadlerDiagnostic Group LLCGSI AMTAS Flex2017-07-26
00810046700266Grason-StadlerDiagnostic Group LLCGSI AMTAS Flex2017-11-29
00810046700273Grason-StadlerDiagnostic Group LLCGSI AMTAS Flex2017-11-29
00810046700488Grason-StadlerDiagnostic Group LLCGSI AudioStar Pro2018-10-22
05713315010279Madsen A450Gn Otometrics A/S8-04-14660 2022-12-28
05713315010286Madsen A450Gn Otometrics A/S8-04-14661 2022-12-28
05713315010293Madsen A450Gn Otometrics A/S8-04-14662 2022-12-28
08054187380020BELLINVENTIS SRLBELL PLUS2016-09-17
08054187380044HARPINVENTIS SRLHARP BASIC2016-09-17
08054187380051HARPINVENTIS SRLHARP BASIC WITH PRINTER2016-09-17
08054187380068HARPINVENTIS SRLHARP PLUS2016-09-17
08054187380075HARPINVENTIS SRLHARP PLUS WITH PRINTER2016-09-17
08054187380082PIANOINVENTIS SRLPIANO BASIC2016-09-17
08054187380099PIANOINVENTIS SRLPIANO BASIC WITH PRINTER2016-09-17
08054187380105PIANOINVENTIS SRLPIANO PLUS2016-09-17
08054187380112PIANOINVENTIS SRLPIANO PLUS WITH PRINTER2016-09-17
08054187380242PIANOINVENTIS SRLPIANO PLUS VRA WITH PRINTER2016-09-17
08054187380365PICCOLOINVENTIS SRLPICCOLO PLUS AERO2016-09-17
08054187380372PICCOLOINVENTIS SRLPICCOLO PLUS2016-09-17
08054187380389PICCOLOINVENTIS SRLPICCOLO SPEECH2016-09-17
08054187380396PICCOLOINVENTIS SRLPICCOLO SPEECH AERO2016-09-17
08054187380402VIOLAINVENTIS SRLVIOLA BASIC2016-09-17
08054187380426VIOLAINVENTIS SRLVIOLA PLUS2016-09-17
08054187380501CELLOINVENTIS SRLCELLO2016-09-17
08054187380518CELLOINVENTIS SRLCELLO AERO2016-09-17
08054187380563TRUMPETINVENTIS SRLTRUMPET AUD2016-09-17
08054187380570TRUMPETINVENTIS SRLTRUMPET REM & AUD2016-09-17
08054187380587BELLINVENTIS SRLBELL PLUS S2016-09-17
08054187380600TRUMPETINVENTIS SRLADDITIONAL LOUDSPEAKER FOR TRUMPET2016-11-23
08054187380914MAESTRO CONTROL PANELINVENTIS SRLMAESTRO CONTROL PANEL2022-12-16
08584270041069Grason-StadlerDiagnostic Group LLCGSI AudioStar Pro2016-11-10
08584270041106TremetricsDiagnostic Group LLCRA8002016-11-10
08584270041151MaicoDiagnostic Group LLCMA 42 2016-11-10
08584270041168MaicoDiagnostic Group LLCMA 522016-09-24
08584270041267MaicoDiagnostic Group LLCMA 272016-11-10
08584270041298MaicoDiagnostic Group LLCDigital Pilot Test 2016-11-10
08584270041311TremetricsDiagnostic Group LLCRA3002016-11-10
08584270041328TremetricsDiagnostic Group LLCHT Wizard Ultra2016-11-10
08584270041526MaicoDiagnostic Group LLCMA 12016-11-10
08584270041533MaicoDiagnostic Group LLCMA 252016-11-10
08584270041557MaicoDiagnostic Group LLCMA 412016-09-24
08584270041724TremetricsDiagnostic Group LLCRA6502016-09-24
08584270041731TremetricsDiagnostic Group LLCHT Wizard PC2016-11-10
B835SHOEBOXAUDIOMETER0SHOEBOX AudiometrySHOEBOX LtdSHOEBOXAUDIOMETER2020-05-28