BCIwiki (bciwiki.com) — According to Sanbo Brain Hospital, China's National Medical Products Administration approved the registration application for the innovative Auditory Brainstem Implant (ABI) on October 20, 2026, under registration number 国械注准20263122152. Professor Wu Hao of Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, led the device trial. The team of Professors Yu Chunjiang and Zhang Mingshan at Sanbo Brain Hospital, Capital Medical University, participated as site principal investigators.
The product is intended for hearing reconstruction in prelingually deaf patients—those whose deafness occurs before language develops—aged 2-6 years, excluding those aged 6. The indication also requires non-tumor-related, non-syndromic deafness accompanied by severe inner ear malformations (Michel malformation, rudimentary otocyst, cochlear aplasia or severe cochlear hypoplasia CH-1) or an absent cochlear nerve that prevents cochlear implantation.
Sanbo Brain Hospital describes the ABI as an invasive brain-computer interface (BCI) for sensory reconstruction. An electrode array is implanted on the surface of the cochlear nucleus in the brainstem, bypassing the cochlea and auditory nerve to stimulate central auditory sensory neurons and produce auditory perception. The implant must be used with its compatible cochlear implant speech processor. The report notes that implantation is technically demanding because the device acts at the brainstem.