{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PLK",
      "openfda": {
        "k_number": [
          "K153634",
          "DEN150002",
          "K182480"
        ],
        "registration_number": [
          "3010863048"
        ],
        "fei_number": [
          "3010863048"
        ]
      },
      "review_panel": "EN",
      "medical_specialty": "EN",
      "device_name": "Tympanic Membrane Direct Contact Hearing Aid",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Ear, Nose, Throat",
      "device_class": "2",
      "definition": "A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.",
      "regulation_number": "874.3315",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}