{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "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": "LXB",
      "openfda": {
        "registration_number": [
          "3034209804",
          "3007275459",
          "3009307953",
          "3007689689",
          "3018094310",
          "3005820796",
          "3013177549",
          "3009632672",
          "3014990990",
          "3033905868",
          "3003847101",
          "9710014",
          "3005900820",
          "3012593436",
          "3003477135",
          "3043654373",
          "9616024",
          "3007743836",
          "3005216725",
          "3009092818",
          "3005150478",
          "9612468",
          "3007367732",
          "3014579188",
          "3027588012",
          "3010097171",
          "9613646",
          "8031010",
          "1045254",
          "3010376846",
          "3006405073",
          "3020283264"
        ],
        "fei_number": [
          "3034209804",
          "3000249315",
          "3007275459",
          "3009307953",
          "3007689689",
          "3018094310",
          "3005820796",
          "3013177549",
          "3009632672",
          "3014990990",
          "3033905868",
          "3003847101",
          "3003222064",
          "3005900820",
          "3012593436",
          "3003477135",
          "3043654373",
          "3007743836",
          "3005216725",
          "3002806429",
          "3009092818",
          "3005150478",
          "3003045432",
          "3007367732",
          "3014579188",
          "3027588012",
          "3010097171",
          "1000185904",
          "1045254",
          "3010376846",
          "3006405073",
          "3020283264"
        ],
        "device_name": "Hearing Aid, Bone Conduction",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3302",
        "device_class": "2"
      },
      "zip_code": "80214",
      "applicant": "Cochlear",
      "decision_date": "2025-05-29",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand",
      "advisory_committee": "EN",
      "contact": "Denis  DiMartino",
      "expedited_review_flag": "",
      "k_number": "K250215",
      "state": "CO",
      "date_received": "2025-01-24",
      "review_advisory_committee": "EN",
      "postal_code": "80214",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}