{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 66
    }
  },
  "results": [
    {
      "pma_number": "P890027",
      "supplement_number": "S046",
      "applicant": "Cochlear Americas",
      "street_1": "10350 Park Meadows Dr.",
      "street_2": "",
      "city": "Lone Tree",
      "state": "CO",
      "zip": "80124",
      "zip_ext": "",
      "generic_name": "Implant, cochlear",
      "trade_name": "AUDALLION BEAMFORMER",
      "product_code": "MCM",
      "advisory_committee": "EN",
      "advisory_committee_description": "Ear, Nose, Throat",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "1998-09-21",
      "decision_date": "1998-09-25",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval of four minor design changes to the Audallion Beamformer Noise Reduction System:  1) switch on/off circuit improvements, 2) replacement of the LC filter with an RC filter, 3) battery spring design change, and 4) a minor software change pertaining to the volume default.  With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion.  Regarding item 2), the RC filter will improve the rejection of the overall RF interference.  For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge.  Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available processor settings on the Audallion, enabling the device to be more user friendly.",
      "openfda": {
        "registration_number": [
          "3014579188",
          "3011823740",
          "2030624",
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        ],
        "fei_number": [
          "3014579188",
          "3011823740",
          "3002806685",
          "3020283264",
          "3000249315",
          "3034170504",
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          "3007743836",
          "3005900820",
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          "3002806740",
          "1721676",
          "3009092818"
        ],
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}