{
  "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": "2026-07-20",
    "results": {
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    {
      "third_party_flag": "N",
      "city": "Lone Tree",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "10350 Park Meadows Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PFO",
      "openfda": {
        "device_name": "Active Implantable Bone Conduction Hearing System",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3340",
        "device_class": "2",
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      "zip_code": "80124",
      "applicant": "Cochlear",
      "decision_date": "2023-08-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App",
      "advisory_committee": "EN",
      "contact": "Denis  DiMartino",
      "expedited_review_flag": "",
      "k_number": "K231204",
      "state": "CO",
      "date_received": "2023-04-27",
      "review_advisory_committee": "EN",
      "postal_code": "80124",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}