{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 140
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Eargo 6 Right HI",
      "public_device_record_key": "56d10e24-d057-44a0-a4d9-f07b90065f5b",
      "has_serial_number": "true",
      "public_version_date": "2023-07-27",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "3",
      "labeler_duns_number": "079865289",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00850010429373",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "99-0150-001",
      "has_manufacturing_date": "true",
      "brand_name": "Eargo 6",
      "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": "K221698",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "1 (855) 690-9360",
          "email": "info@eargo.com"
        }
      ],
      "company_name": "Eargo, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34672",
          "name": "Air-conduction hearing aid, in-the-ear",
          "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) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 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": "2021-12-21"
    }
  ]
}