{
  "code": "ESD",
  "deviceName": "Hearing Aid, Air-Conduction, Prescription",
  "deviceClass": "I",
  "regulationNumber": "874.3300",
  "panel": "Ear, Nose, Throat",
  "definition": "An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.",
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1367,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 76,
    "last12Months": 37
  },
  "reviewDays": {
    "median": 42,
    "sampleSize": 1367
  },
  "recalls": {
    "total": 4,
    "recent": [
      {
        "resNumber": "Z-0583-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "GN Hearing A/S",
        "firmAsPublished": "GN Hearing A/S",
        "reason": "GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users  residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.",
        "initiated": "2019-09-18"
      },
      {
        "resNumber": "Z-0584-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "GN Hearing A/S",
        "firmAsPublished": "GN Hearing A/S",
        "reason": "GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.",
        "initiated": "2019-09-18"
      },
      {
        "resNumber": "Z-0094-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Widex A/S",
        "firmAsPublished": "Widex A/S",
        "reason": "The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids.  The correct battery drawer is tamper-resistant and require a special tool to open it.",
        "initiated": "2018-08-31"
      },
      {
        "resNumber": "Z-1681-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Insound Medical, Inc.",
        "firmAsPublished": "InSound Medical, Inc.",
        "reason": "Manufacturing error could result in electrolyte leakage from the product's battery.",
        "initiated": "2010-01-19"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K232999",
      "deviceName": "Lyric4 Hearing Aid",
      "applicant": "Sonova AG",
      "company": "Sonova AG",
      "decisionDate": "2024-04-11",
      "dateReceived": "2023-09-22"
    },
    {
      "kNumber": "K130790",
      "deviceName": "LYRIC2",
      "applicant": "Phonak, LLC",
      "company": "Phonak, Inc.",
      "decisionDate": "2013-06-27",
      "dateReceived": "2013-03-22"
    },
    {
      "kNumber": "K081136",
      "deviceName": "LYRIC HEARING AID",
      "applicant": "Insound Medical, Inc.",
      "company": "Insound Medical, Inc.",
      "decisionDate": "2008-05-08",
      "dateReceived": "2008-04-21"
    },
    {
      "kNumber": "K021867",
      "deviceName": "INSOUND XT SERIES HEARING AID",
      "applicant": "Insound Medical, Inc.",
      "company": "Insound Medical, Inc.",
      "decisionDate": "2002-11-19",
      "dateReceived": "2002-06-06"
    },
    {
      "kNumber": "K003558",
      "deviceName": "TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)",
      "applicant": "Siemens Hearing Instruments, Inc.",
      "company": "Siemens Hearing Instruments, Inc",
      "decisionDate": "2001-04-24",
      "dateReceived": "2000-11-17"
    },
    {
      "kNumber": "K984518",
      "deviceName": "SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL",
      "applicant": "Sonic Innovations, Inc.",
      "company": "Sonic Innovations, Inc.",
      "decisionDate": "1999-03-12",
      "dateReceived": "1998-12-21"
    },
    {
      "kNumber": "K974751",
      "deviceName": "TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC",
      "applicant": "General Hearing Instruments, Inc.",
      "company": "General Hearing Instruments, Inc.",
      "decisionDate": "1998-03-06",
      "dateReceived": "1997-12-19"
    },
    {
      "kNumber": "K974242",
      "deviceName": "ARGOSY PROGRAMMABLE ONQUE",
      "applicant": "Argosy Electronics",
      "company": "Argosy Electronics",
      "decisionDate": "1998-01-20",
      "dateReceived": "1997-11-12"
    },
    {
      "kNumber": "K973880",
      "deviceName": "SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM",
      "applicant": "Sonix Technologies, Inc.",
      "company": "Sonix Technologies, Inc.",
      "decisionDate": "1998-01-12",
      "dateReceived": "1997-10-14"
    },
    {
      "kNumber": "K974211",
      "deviceName": "OPUS 2 - FULL CONCHA SERIES - ITE",
      "applicant": "Bernafon-Maico, Inc.",
      "company": "Bernafon-Maico, Inc.",
      "decisionDate": "1997-12-15",
      "dateReceived": "1997-11-10"
    }
  ],
  "topApplicants": [
    {
      "name": "Unitron Industries, Inc.",
      "count": 69
    },
    {
      "name": "Miracle-Ear, Inc.",
      "count": 64
    },
    {
      "name": "Electone, Inc.",
      "count": 63
    },
    {
      "name": "Oticon Corp.",
      "count": 54
    },
    {
      "name": "Widex Hearing Aid Co., Inc.",
      "count": 51
    }
  ],
  "topCompanies": [
    {
      "name": "Unitron Industries, Inc.",
      "count": 69,
      "spellings": 1
    },
    {
      "name": "Miracle-Ear, Inc.",
      "count": 64,
      "spellings": 1
    },
    {
      "name": "Electone, Inc.",
      "count": 63,
      "spellings": 1
    },
    {
      "name": "Oticon Corp.",
      "count": 63,
      "spellings": 2
    },
    {
      "name": "Widex Hearing Aid Co., Inc.",
      "count": 51,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "ESD (Hearing Aid, Air-Conduction, Prescription): 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%3AESD"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AESD"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AESD"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AESD"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AESD"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AESD"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AESD"
    }
  ],
  "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"
}