# Contact Forte Alpha

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/contact-forte-alpha-lxb>
- Manufacturer: [Bhm-Tech Produktionsgesellschaft Mbh](https://devicerts.com/manufacturers/bhm-tech-produktionsgesellschaft-mbh) (Austria)
- Name in the registry: contact forte Alpha
- Device class: Class II (US FDA)
- FDA product code: LXB

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

This 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K243041 · decision 2025-04-25 · decision SESE · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K243041 [FDA 510(k)]
- FDA product code: LXB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 874.3302 [FDA 510(k)]
- Advisory committee: Ear, Nose, Throat [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- 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).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/contact-forte-alpha-lxb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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
- 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.