{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SCR",
      "openfda": {
        "k_number": [
          "K254044",
          "K251208",
          "K243150",
          "DEN230081"
        ],
        "registration_number": [
          "9617804",
          "3014343954",
          "3011016506",
          "3023339161"
        ],
        "fei_number": [
          "3001556165",
          "3014343954",
          "3011016506",
          "3023339161"
        ]
      },
      "review_panel": "EN",
      "medical_specialty": "EN",
      "device_name": "Air-Conduction Hearing Aid Software",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Ear, Nose, Throat",
      "device_class": "2",
      "definition": "Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.",
      "regulation_number": "874.3335",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}