Sbo Hearing A/S

Sbo Hearing A/S specializes in air-conduction hearing aids across various form factors, including receiver-in-the-ear, behind-the-ear, in-the-ear, and canal designs. Their portfolio also includes wireless-fitting computer-aided software for hearing devices, remote controls for hearing aid/implant systems, and noninvasive battery chargers for hearing aids. These devices are designed to complement major brands like Oticon, Philips, and EarQ.

Sbo Hearing A/S is headquartered in Denmark, as indicated by its regulatory and product documentation.

Sbo Hearing A/S’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized in the U.S. This inclusion helps ensure traceability and compliance with regulatory requirements.

Sbo Hearing A/S’s devices fall under Class I and Class II classifications, depending on their design, intended use, and associated risks. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.

Yes, Sbo Hearing A/S’s devices are designed to be compatible with major hearing aid brands such as Oticon, Philips, and EarQ. Their product line includes accessories like wireless-fitting software, remote controls, and battery chargers that enhance functionality for these branded systems, ensuring seamless integration and user experience.