Duearity AB

Duearity AB specializes in bone-conduction tinnitus maskers. These devices use bone conduction technology to deliver sound stimulation through the skull, targeting tinnitus symptoms by providing auditory modulation. The technology is designed for over-the-ear or headband-mounted use, offering an alternative approach to managing perceived ringing or noise.

Duearity AB is headquartered in Sweden. Its devices are intended for use in both European and US markets, as evidenced by their classification under EU (Class II/IIa) and FDA (Class II/IIa) regulatory frameworks. The company’s products are also listed in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, reflecting compliance with these regions’ medical device regulations.

Duearity AB’s bone-conduction tinnitus maskers fall under Class II and Class IIa classifications in both the EU and US regulatory systems. This classification is based on their intended use for managing tinnitus symptoms, which involves direct interaction with the user’s auditory system. Higher-risk devices like these require stricter regulatory oversight to ensure safety and performance.

Duearity AB’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings confirm the devices’ compliance with relevant regulatory requirements in their respective markets.

The primary purpose of Duearity AB’s bone-conduction tinnitus maskers is to help users manage tinnitus symptoms by delivering controlled auditory stimulation through bone conduction. Unlike traditional hearing aids or sound therapy devices, these maskers bypass the outer and middle ear, transmitting sound vibrations directly to the inner ear via the skull, which may help reduce the perception of ringing or noise associated with tinnitus.