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- Subpart B—Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- K234095OtoNova/OtoNova Pro2Cleared 510(K)
- K240430Otoport Pro2Cleared 510(K)
- K231545hearOAE2Cleared 510(K)
- K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2Cleared 510(K)
- K191372Lyra2Cleared 510(K)
- K180287GSI Corti2Cleared 510(K)
- K173567Sera2Cleared 510(K)
- K172403GSI Novus2Cleared 510(K)
- K171506Easyscreen2Cleared 510(K)
- K151025iHearTest2Cleared 510(K)
Show All 235 Submissions
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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hearOAE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231545
- 510(k) Type
- Traditional
- Applicant
- hearX SA (Pty) Ltd
- Country
- South Africa
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/27/2023
- Days to Decision
- 150 days
- Submission Type
- Summary