{
  "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": 125
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "MR Unsafe",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Lexie B3 Hearing Aids",
      "public_device_record_key": "158c4914-76fa-4fd5-bf55-5f38d50207b9",
      "has_serial_number": "true",
      "public_version_date": "2026-05-15",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "539177681",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00810153660323",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "Lexie Hearing",
      "has_manufacturing_date": "true",
      "brand_name": "Lexie B3 Hearing Aids",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "QUH",
          "name": "Self-Fitting Air-Conduction Hearing Aid, Over The Counter",
          "openfda": {
            "device_name": "Self-Fitting Air-Conduction Hearing Aid, Over The Counter",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.3325",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K223137",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "LBS00001B3",
      "company_name": "HEARX GROUP (PTY) LTD",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "47169",
          "name": "Air-conduction hearing aid, receiver-in-canal",
          "definition": "A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. The device is used for mild to profound 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": "2026-05-07"
    }
  ]
}