BHM-Tech Produktionsgesellschaft m.b.H.

BHM-Tech specializes in air-conduction hearing aids designed to be worn behind the ear. Their primary focus is on behind-the-ear hearing aids, including customizable earmold components such as mini contacts, extension tips, and headbands. These devices are tailored to fit different user needs, like the Hearbow models for specific earmold types or accessories like the SOFTBAND/BC6/BIN/BL.

The company is headquartered in Austria, as indicated by its country designation. This location places it within the European Economic Area, which is relevant for compliance with EU medical device regulations.

BHM-Tech’s devices are listed in the eudamed database, the EU’s centralised registry for medical devices within the European Economic Area. This registry is used to track and monitor devices under the EU Medical Device Regulations, ensuring transparency and traceability.

BHM-Tech’s devices fall under Class I and Class IIa classifications in the EU Medical Device Regulations. The classification depends on factors like the device’s risk level, intended use, and potential health impact. For example, custom earmold components like extension tips or headbands are typically lower risk (Class I), while certain hearing aid models may require additional scrutiny (Class IIa).

The classification determines the regulatory requirements for each device, including design controls, clinical evaluations, and post-market surveillance. Class I devices generally face fewer stringent requirements than Class IIa, which may require additional documentation or conformity assessments to ensure safety and performance. This classification helps authorities and users assess the device’s risk level.