{
  "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": "QUH",
      "openfda": {
        "k_number": [
          "K221052",
          "K254108",
          "K223848",
          "K223137",
          "K233464",
          "K230538",
          "K231550",
          "K233747",
          "K221064",
          "K221698"
        ],
        "registration_number": [
          "3026048380",
          "3007344957",
          "3005650109",
          "3008848788",
          "3006312495",
          "3013294311",
          "3011927597",
          "3015651976",
          "3023339161",
          "3018940143",
          "3002808415",
          "3015246392",
          "3011586575",
          "2182204",
          "3008941158",
          "3040068315",
          "3039409159",
          "3005019184",
          "3015527983",
          "3006011998",
          "3014337591",
          "3041658266",
          "3024991168",
          "3005085999",
          "3030627827",
          "3027202846",
          "3003303986",
          "3003426343",
          "3010841212"
        ],
        "fei_number": [
          "3026048380",
          "3007344957",
          "3005650109",
          "3008848788",
          "3006312495",
          "3013294311",
          "3011927597",
          "3015651976",
          "3023339161",
          "3018940143",
          "3002808415",
          "3015246392",
          "3011586575",
          "2182204",
          "3008941158",
          "3040068315",
          "3039409159",
          "3005019184",
          "3015527983",
          "3006011998",
          "3014337591",
          "3041658266",
          "3024991168",
          "3005085999",
          "3030627827",
          "3027202846",
          "3003303986",
          "3003426343",
          "3010841212"
        ]
      },
      "review_panel": "EN",
      "medical_specialty": "EN",
      "device_name": "Self-Fitting Air-Conduction Hearing Aid, Over The Counter",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Ear, Nose, Throat",
      "device_class": "2",
      "definition": "A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid.    For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.",
      "regulation_number": "874.3325",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}