{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "PFO",
      "openfda": {
        "k_number": [
          "K260902",
          "K220922",
          "K183373",
          "K240155",
          "K231204",
          "DEN170009",
          "K191457",
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          "K191921",
          "K200504",
          "K201983",
          "K240614"
        ],
        "registration_number": [
          "3009092818",
          "3032579106",
          "3013177549",
          "3009307953",
          "9710014",
          "9616024",
          "3006405073",
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        "fei_number": [
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      },
      "review_panel": "EN",
      "medical_specialty": "EN",
      "device_name": "Active Implantable Bone Conduction Hearing System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Ear, Nose, Throat",
      "device_class": "2",
      "definition": "An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.",
      "regulation_number": "874.3340",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}