{
  "format": "devicerts.device.v1",
  "cite_as": "Contact Forte Alpha, Bhm-Tech Produktionsgesellschaft Mbh. deviCERTS medical device catalogue. https://devicerts.com/devices/contact-forte-alpha-lxb (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/contact-forte-alpha-lxb",
    "json_url": "https://devicerts.com/devices/contact-forte-alpha-lxb.json",
    "markdown_url": "https://devicerts.com/devices/contact-forte-alpha-lxb.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/contact-forte-alpha-lxb",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Contact Forte Alpha",
    "registry_name": "contact forte Alpha",
    "url": "https://devicerts.com/devices/contact-forte-alpha-lxb",
    "manufacturer": {
      "name": "Bhm-Tech Produktionsgesellschaft Mbh",
      "url": "https://devicerts.com/manufacturers/bhm-tech-produktionsgesellschaft-mbh",
      "country": "Austria",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K243041",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LXB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Contact Forte Alpha is a bone conduction hearing aid designed to compensate for mild to moderate hearing impairment. It processes and amplifies sound before transmitting vibrations directly to the inner ear via bone conduction technology, bypassing the outer and middle ear.\n\nThis device is supplied as a reusable, digital hearing system with wireless connectivity, including Bluetooth compatibility. It is classified as a Class II medical device under FDA regulations and the Medical Devices Directive (MDD), with an FDA 510(k) clearance (K243041) and product code LXB. No sterility or single-use specifications are indicated.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K243041",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-04-25",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K243041",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LXB",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.3302",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ear, Nose, Throat",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}