Widex A/S

Widex A/S specializes in air-conduction hearing aids, offering multiple form factors such as receiver-in-canal, behind-the-ear, canal, and in-the-ear designs. Their portfolio also includes audiometric/hearing device software, noninvasive battery chargers, and remote controls for hearing aid/implant systems. These devices are designed to address hearing loss and improve auditory function for users.

Widex A/S is headquartered in Denmark. The company’s location in Denmark reflects its focus on European and global markets for hearing healthcare solutions, though its devices are distributed and used worldwide.

Widex A/S devices are listed in the FDA’s UDI (Unique Device Identification) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Widex A/S devices fall under Class I and Class II regulatory classifications. Class I devices generally pose minimal risk and often require less stringent regulatory oversight, while Class II devices involve a higher level of risk and may require special controls or performance standards to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.