{
  "code": "EWO",
  "deviceName": "Audiometer",
  "deviceClass": "II",
  "regulationNumber": "874.1050",
  "panel": "Ear, Nose, Throat",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 235,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 20,
    "last12Months": 10
  },
  "reviewDays": {
    "median": 85,
    "sampleSize": 235
  },
  "recalls": {
    "total": 5,
    "recent": [
      {
        "resNumber": "Z-0401-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "PATH",
        "firmAsPublished": "PATH",
        "reason": "Affected lots of product may experience technical distortions to a greater extent than expected.",
        "initiated": "2023-09-26"
      },
      {
        "resNumber": "Z-0402-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "PATH",
        "firmAsPublished": "PATH",
        "reason": "Affected lots of product may experience technical distortions to a greater extent than expected.",
        "initiated": "2023-09-26"
      },
      {
        "resNumber": "Z-0403-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "PATH",
        "firmAsPublished": "PATH",
        "reason": "Affected lots of product may experience technical distortions to a greater extent than expected.",
        "initiated": "2023-09-26"
      },
      {
        "resNumber": "Z-0404-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "PATH",
        "firmAsPublished": "PATH",
        "reason": "Affected lots of product may experience technical distortions to a greater extent than expected.",
        "initiated": "2023-09-26"
      },
      {
        "resNumber": "Z-0195-2009",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Cardinal Health",
        "firmAsPublished": "Cardinal Health, Inc",
        "reason": "GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions.  \n\nA. Split Screen Field Correction:\nGSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear.   When using 2.6 software in split-screen mod",
        "initiated": "2008-09-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K234095",
      "deviceName": "OtoNova/OtoNova Pro",
      "applicant": "Otodynamics",
      "company": "Otodynamics, Ltd.",
      "decisionDate": "2024-06-21",
      "dateReceived": "2023-12-26"
    },
    {
      "kNumber": "K240430",
      "deviceName": "Otoport Pro",
      "applicant": "Otodynamics, Ltd.",
      "company": "Otodynamics, Ltd.",
      "decisionDate": "2024-03-15",
      "dateReceived": "2024-02-14"
    },
    {
      "kNumber": "K231545",
      "deviceName": "hearOAE",
      "applicant": "Hearx SA (Pty) , Ltd.",
      "company": "Hearx SA (Pty) , Ltd.",
      "decisionDate": "2023-10-27",
      "dateReceived": "2023-05-30"
    },
    {
      "kNumber": "K213345",
      "deviceName": "Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE",
      "applicant": "Path Medical GmbH",
      "company": "Path Medical GmbH",
      "decisionDate": "2022-06-22",
      "dateReceived": "2021-10-08"
    },
    {
      "kNumber": "K191372",
      "deviceName": "Lyra",
      "applicant": "Interacoustics A/S",
      "company": "Interacoustics A/S",
      "decisionDate": "2019-07-15",
      "dateReceived": "2019-05-22"
    },
    {
      "kNumber": "K180287",
      "deviceName": "GSI Corti",
      "applicant": "Grason-Stadler, Inc.",
      "company": "Grason-Stadler, Inc.",
      "decisionDate": "2018-05-11",
      "dateReceived": "2018-02-01"
    },
    {
      "kNumber": "K173567",
      "deviceName": "Sera",
      "applicant": "Interacoustics A/S",
      "company": "Interacoustics A/S",
      "decisionDate": "2018-02-14",
      "dateReceived": "2017-11-20"
    },
    {
      "kNumber": "K172403",
      "deviceName": "GSI Novus",
      "applicant": "Grason-Stadler, Inc.",
      "company": "Grason-Stadler, Inc.",
      "decisionDate": "2017-10-20",
      "dateReceived": "2017-08-09"
    },
    {
      "kNumber": "K171506",
      "deviceName": "Easyscreen",
      "applicant": "Maico Diagnostics GmbH",
      "company": "Maico Diagnostics GmbH",
      "decisionDate": "2017-08-29",
      "dateReceived": "2017-05-23"
    },
    {
      "kNumber": "K151025",
      "deviceName": "iHearTest",
      "applicant": "Ihear Medical, Inc.",
      "company": "Ihear Medical, Inc.",
      "decisionDate": "2015-12-29",
      "dateReceived": "2015-04-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Maico Hearing Instruments, Inc.",
      "count": 20
    },
    {
      "name": "Grason-Stadler, Inc.",
      "count": 12
    },
    {
      "name": "Bio-Logic Systems Corp.",
      "count": 9
    },
    {
      "name": "Otodynamics, Ltd.",
      "count": 7
    },
    {
      "name": "Tracor Instruments, Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Maico Hearing Instruments, Inc.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Grason-Stadler, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Bio-Logic Systems Corp.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Etymotic Research, Inc.",
      "count": 8,
      "spellings": 2
    },
    {
      "name": "Otodynamics, Ltd.",
      "count": 8,
      "spellings": 2
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EWO (Audiometer): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AEWO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEWO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEWO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEWO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEWO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEWO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEWO"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.695Z"
}