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Contact Forte Alpha

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243041

by Bhm-Tech Produktionsgesellschaft Mbh

Identifiers

510(k) Number
K243041 FDA 510(k)
FDA Product Code
LXB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3302 FDA 510(k)
Regulation Number
874.3302 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What types of hearing impairments is the Contact Forte Alpha designed to address and how does it work?

The Contact Forte Alpha is specifically designed to compensate for mild to moderate hearing impairment. It uses bone conduction technology to process and amplify sound, then transmits vibrations directly to the inner ear, bypassing the outer and middle ear. This approach helps users perceive sound without relying on traditional ear canal placement.

Is the Contact Forte Alpha a single-use or reusable device, and what does this mean for maintenance?

The Contact Forte Alpha is a reusable digital hearing system. Since it is not intended for single-use, it can be cleaned and maintained over time, though proper care is required to ensure optimal performance and hygiene. The manufacturer’s instructions should be followed for cleaning and storage.

Does the Contact Forte Alpha support wireless connectivity, and what features does this include?

Yes, the Contact Forte Alpha includes wireless connectivity, specifically Bluetooth compatibility. This allows users to pair the device with other Bluetooth-enabled devices, such as smartphones or audio systems, for enhanced functionality and convenience.

What regulatory pathways has the Contact Forte Alpha followed, and what does this mean for its use?

The Contact Forte Alpha has received FDA 510(k) clearance (K243041) under the Traditional pathway and is classified as a Class II medical device. It is also compliant with the Medical Devices Directive (MDD). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets safety and performance standards for use in clinical settings.

Are there different models or sizes available for the Contact Forte Alpha, and how might this affect selection?

The Contact Forte Alpha is listed with multiple registration numbers (e.g., 3007275459, 3013177549, etc.), which may correspond to different models or variations. While specific size or model details are not provided, these variations could relate to features, programming options, or compatibility with different user needs. Clinicians or users should consult the manufacturer for guidance on selecting the appropriate model based on individual requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: contact forte - BHM Tech, BHM - Nice to hear you again - BHM Tech, K243041 FDA 510(k) - contact forte Alpha

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bhm-Tech Produktionsgesellschaft Mbh

Sources (2)

  • FDA 510(k) K243041 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026