{
  "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": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 60681
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "MR Unsafe",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "public_device_record_key": "ca085743-0bea-4e18-a09a-0c2ea1459ccc",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "60"
          },
          "low": {
            "unit": "Degrees Celsius",
            "value": "-40"
          }
        },
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "95"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        }
      ],
      "public_version_date": "2025-08-20",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "4",
      "labeler_duns_number": "055461479",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00842318100597",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "AGXS3S I20 CIC",
      "has_manufacturing_date": "true",
      "brand_name": "AUDIGY",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "OSM",
          "name": "Hearing aid, air conduction with wireless technology",
          "openfda": {
            "device_name": "Hearing Aid, Air-Conduction With Wireless Technology, Prescription",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.3305",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "false",
      "catalog_number": "AUYTT4O",
      "company_name": "Starkey Laboratories, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "41209",
          "name": "Air-conduction hearing aid, canal",
          "definition": "A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-15"
    }
  ]
}