FDA.report

Evoked-potential audiometer

Definition
An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
GUDID devices
573
Last updated
2026-02-06 21:47:17

Related Product Codes

CodeDeviceSpecialtyClassDevices
GWJStimulator, Auditory, Evoked ResponseNeurology2331
EWOAudiometerEar, Nose, Throat2210
ETYTester, Auditory ImpedanceEar, Nose, Throat213
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat19
IKDCable, ElectrodePhysical Medicine27
GWFStimulator, Electrical, Evoked ResponseNeurology21
GXYElectrode, CutaneousNeurology21
OMCReduced- Montage Standard ElectroencephalographNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
05713315012068Echo-Screen IIINatus Medical Denmark ApS0135702026-01-29
05713315012013Echo-Screen IIINatus Medical Denmark ApS0091492026-01-28
05713315012037Echo-Screen IIINatus Medical Denmark ApS0109992026-01-28
05713315012051Echo-Screen IIINatus Medical Denmark ApS0126252026-01-28
05713315011436ALGO ProNatus Medical Denmark ApS0361772026-01-23
05713315011443ALGO ProNatus Medical Denmark ApS0362442026-01-23
05713315011450ALGO ProNatus Medical Denmark ApS0362342026-01-23
05713315011467ALGO ProNatus Medical Denmark ApS0362352026-01-23
05713315011474ALGO ProNatus Medical Denmark ApS0362362026-01-23
05713315011481Algo ProNatus Medical Denmark ApS0362372026-01-23
05713315011498ALGO ProNatus Medical Denmark ApS0420552026-01-23
05713315011504ALGO ProNatus Medical Denmark ApS0415542026-01-23
05713315011511ALGO ProNatus Medical Denmark ApS0362432026-01-23
05713315012075OAE EartipsNatus Medical Denmark ApS2032012025-12-22
05713315012082OAE EartipsNatus Medical Denmark ApS2032022025-12-22
05713315012099OAE EartipsNatus Medical Denmark ApS2032082025-12-22
05713315012105OAE EartipsNatus Medical Denmark ApS2032092025-12-22
05713315012112OAE EartipsNatus Medical Denmark ApS2032102025-12-22
05713315012129OAE EartipsNatus Medical Denmark ApS2032112025-12-22
05713315012136OAE EartipsNatus Medical Denmark ApS2032122025-12-22
05713315012143OAE EartipsNatus Medical Denmark ApS2032182025-12-22
05713315012150OAE EartipsNatus Medical Denmark ApS2032192025-12-22
05713315011726Algo 3iNatus Medical Denmark ApS0306972025-12-17
05713315012211Algo 3iNatus Medical Denmark ApS0406562025-12-17
05713315012228Algo 3iNatus Medical Denmark ApS0107242025-12-17
05713315012235Algo 3iNatus Medical Denmark ApS0107262025-12-17
05713315012242Algo 3iNatus Medical Denmark ApS0407402025-12-17
05713315011702FlexicouplerNatus Medical Denmark ApS0114452025-12-11
05713315011979 ALGONatus Medical Denmark ApS0405322025-12-11
05713315011986FlexicouplerNatus Medical Denmark ApS0405462025-12-11
05713315011993FlexicouplerNatus Medical Denmark ApS0406702025-12-11
05713315011733Jelly Tab SensorsNatus Medical Denmark ApS0405872025-12-02
05713315011740Jelly Tab SensorsNatus Medical Denmark ApS0405172025-12-02
05713315012006Jelly Tab SensorsNatus Medical Denmark ApS1016612025-12-02
05713315012167ALGO 5Natus Medical Denmark ApS0006962025-12-02
05713315012174ALGO 5Natus Medical Denmark ApS000698C2025-12-02
05713315012181ALGO 5Natus Medical Denmark ApS0009542025-12-02
05713315012198ALGO 5Natus Medical Denmark ApS0111202025-12-02
05713315012204ALGO 5Natus Medical Denmark ApS0409512025-12-02
04260223147418Sentiero Screening 3PATH medical GmbH100098-S32025-08-05
04260223147630Sentiero Screening3 DPOAE SetPATH medical GmbH100250-SC3-D-LT2025-08-05
04260223147647Sentiero Screening3 TEOAE SetPATH medical GmbH100250-SC3-T-LT2025-08-05
04250307604517ISISinomed Medizintechnik GmbH5403402022-09-16
04260223144783Headphone DD-65 v2PATH medical GmbH1010442024-09-17
04260223147272QScreen SetPATH medical GmbH101275-AS-ECC2024-09-17
04260223147289QScreen SetPATH medical GmbH101275-AS-EP2024-09-17
04260223147296QScreen SetPATH medical GmbH101275-AS-IP2024-09-17
04260223147302QScreen SetPATH medical GmbH101275-AS-HP2024-09-17
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProOTODYNAMICS LIMITEDNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProOTODYNAMICS LIMITEDNPRO-TEC2024-08-20
05060396173127OtoNova Pro Screener AABROTODYNAMICS LIMITEDNPRO-SCR-A2024-08-20
05060396172373ABR Electrode Cable V2 (SNAP) for Otoport V2/ProOTODYNAMICS LIMITEDOPRO-SEC2024-07-17
05060396172380ABR Electrode Cable V2 (TAB) for Otoport V2/ProOTODYNAMICS LIMITEDOPRO-TEC2024-07-17
05060396173066ABR Electrode Cable V2 (NHSP) for Otoport V2/ProOTODYNAMICS LIMITEDOPRO-NEC2024-07-17
05060396173097Otoport Pro OAE+AABR instrumentOTODYNAMICS LIMITEDOPRO-O+A2024-07-17
05060396173219Otoport Pro Screener AABROTODYNAMICS LIMITEDOPRO-SCR-A2024-07-17
05060396173226Otoport Pro Screener DP+AABR OTODYNAMICS LIMITEDOPRO-SCR-DA2024-07-17
05060396173233Otoport Pro Screener TE+AABR OTODYNAMICS LIMITEDOPRO-SCR-TA2024-07-17
05060396173448Otoport Pro OAE instrumentOTODYNAMICS LIMITEDOPRO-O2024-07-17
05060396173455Otoport Pro AABR instrumentOTODYNAMICS LIMITEDOPRO-A2024-07-17
04260223142994Sentiero Desktop DiagnosticPATH medical GmbH1004972024-05-22
04260223147210Ear Tip PM009H Pack/100 pcs.PATH medical GmbH100767-PH-1002024-05-22
04260223147227Ear Tip PM010H Pack/100 pcs.PATH medical GmbH100768-PH-1002024-05-22
04260223146572Ear Tip ET-LT40G Pack/100 pcs.PATH medical GmbH101365-1002023-11-14
04260223146596Ear Tip ET-LT45G Pack/100 pcs.PATH medical GmbH101366-1002023-11-14
04260223146619Ear Tip ET-LT50G Pack/100 pcs.PATH medical GmbH101367-1002023-11-14
04260223146633Ear Tip ET-LT60M Pack/100 pcs.PATH medical GmbH101368-1002023-11-14
04260223146961Accessory Box AB09PATH medical GmbH101379-PS2023-11-14
04260223146978Ear Tip PM007H Pack/100 pcs.PATH medical GmbH100765-PH-1002023-11-14
04260223146985Ear Tip PM011H Pack/100 pcs.PATH medical GmbH100769-PH-1002023-11-14
04260223146992Ear Tip PM012H Pack/100 pcs.PATH medical GmbH100770-PH-1002023-11-14
04260223147005Ear Tip PM013H Pack/100 pcs.PATH medical GmbH100771-PH-1002023-11-14
04260223147012Ear Tip PM014H Pack/100 pcs.PATH medical GmbH100772-PH-1002023-11-14
04260223147029Ear Tip PM016H Pack/100 pcs.PATH medical GmbH100773-PH-1002023-11-14
04260223147036Ear Tip PM018H Pack/100 pcs.PATH medical GmbH100774-PH-1002023-11-14
04260223146251QScreen SetPATH medical GmbH101275-T-A-ECC2023-05-19
04260223146268QScreen SetPATH medical GmbH101275-A-ECC2023-05-19
04260223146275QScreen SetPATH medical GmbH101275-A-IP2023-05-19
04260223146282QScreen SetPATH medical GmbH101275-D2023-05-19
04260223146299QScreen SetPATH medical GmbH101275-D-A-ECC2023-05-19