NMPA approves China’s first auditory brainstem implant

On October 20, 2026, the National Medical Products Administration announced the approval of the innovative product registration application for the “Auditory Brainstem Implant” from Zhejiang Nurotron Neuroelectronic Technology Co., Ltd., which is listed as item No. 447 among NMPA-approved innovative medical devices, with an approval date of October 19, 2026, and registration certificate No. Domestic Medical Device Registration Certificate 20263122152—an approval that marks China’s first domestically developed auditory brainstem implant and a breakthrough in brainstem neuromodulation.

The product consists of a stimulator, receiver coil, intracranial electrode array, extracranial plate electrode, extracranial ring electrode, and internal magnet, and is used with the company’s cochlear implant speech processor. It decodes digital information from the external speech processor and converts it into current pulses, directly stimulating the auditory center at the cochlear nucleus through the electrode array to help users restore hearing.

It is indicated for prelingually deaf patients aged 2 to under 6 years with non-tumor-induced non-syndromic deafness who also have severe inner ear malformations (Michel deformity, primitive otocyst, cochlear aplasia, or severe cochlear hypoplasia CH-1) or cochlear nerve aplasia and are unable to receive a cochlear implant.

This is China’s first domestically developed auditory brainstem implant (ABI) and the country’s first product for electrical stimulation and neural signal extraction in the brainstem region, filling the domestic gap in the ABI field. The drug regulatory authority will strengthen post-market surveillance to protect patient safety.