{
  "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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  "results": [
    {
      "third_party_flag": "N",
      "city": "Bartlett",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "2925 Appling Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NIX",
      "openfda": {
        "device_name": "Hearing Aid, Air Conduction, Transcutaneous System",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3950",
        "device_class": "2"
      },
      "zip_code": "38133",
      "applicant": "Gyrus Ent LLC",
      "decision_date": "2004-08-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM",
      "advisory_committee": "EN",
      "contact": "ALICIA E FARAGE",
      "expedited_review_flag": "",
      "k_number": "K040996",
      "state": "TN",
      "date_received": "2004-04-16",
      "review_advisory_committee": "EN",
      "postal_code": "38133",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
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}