FDA.reportPublic FDA data

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
75
Last updated
2026-06-13 06:05:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810046707562Grason-StadlerDiagnostic Group LLCGSI AudioHub2026-06-04
00817020020877SmartAudiometer SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8170002016-09-24
00817020020358Sound Field Connector to Amp Cable (Mono Plugs)INTELLIGENT HEARING SYSTEMS CORP.M0257012016-09-24
00817020020365Sound Field Output Cable to Amplifier (RCA Plugs)INTELLIGENT HEARING SYSTEMS CORP.M0257042016-09-24
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.Sennheiser HD280 Pro for i152026-06-02
05745000311064OscillaOscilla A/SOscilla® A50 w. H210 headset & B71 Bone C.2026-05-29
05745000311095OscillaOscilla A/SOscilla® A60 w. H210 headset & B71 Bone C.2026-05-29
05745000311156OscillaOscilla A/SOscilla® A30 w. DD65 headset2026-05-29
05745000311163OscillaOscilla A/SOscilla® A30 w. H210A headset2026-05-29
05745000311187OscillaOscilla A/SOscilla® A50 w. H210A headset & BC-2 Bone C.2026-05-29
05745000311200OscillaOscilla A/SOscilla® A60 w. H210A headset & BC-2 Bone C.2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCGSI AudioHub2026-04-06
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 SoftwareWAHTS HEARING 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 A450Natus Medical Denmark ApS8-04-14660 2022-12-28
05713315010286Madsen A450Natus Medical Denmark ApS8-04-14661 2022-12-28
05713315010293Madsen A450Natus Medical Denmark ApS8-04-14662 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