Beijing (AsiaNews) – Beijing has approved the first Made in China auditory brainstem implant for clinical use in patients suffering from deafness, as part of a national initiative to commercialise brain-computer interface (BCI) technologies.
The device is intended for deaf children who cannot use traditional cochlear implants, often referred to as "bionic ears", due to malformations of the inner ear.
Approved on 19 October by China’s National Medical Products Administration (NMPA), the implant (Nurotron WH-01A) is classified as a Class III medical device, the highest-risk category under the national medical device regulatory system.
An innovative project
The device was developed by a team led by Wu Hao, a surgeon and professor of otolaryngology at the Ninth People’s Hospital, affiliated with the Shanghai Jiao Tong University School of Medicine. The project benefited from the contribution of Zhejiang Nurotron Biotechnology, a company based in the city of Hangzhou, in eastern China.
The implant is designed to restore hearing in patients who cannot benefit from conventional devices due to severe inner-ear malformations or the absence of the cochlear nerve, which typically transmits auditory information from the inner ear to the brain.
Unlike cochlear implants, which stimulate the nerve via the inner ear, a brainstem implant bypasses both the cochlea and the cochlear nerve, sending electrical impulses directly to the cochlear nucleus. This is a structure within the brainstem through which all sound information enters the brain and where the processing of sound begins.
Eligible patients include children between the ages of two and six with nonsyndromic deafness, that is, deafness not associated with other medical conditions or physical abnormalities, as well as individuals whose deafness is not caused by tumours or who cannot benefit from cochlear implants.
A challenge to the US
The approval comes at a time when China is intensifying its efforts to advance the BCI sector, a field hitherto dominated by US companies, towards clinical use and commercialisation, supported by new investments and progress in artificial intelligence (AI).
A brain-computer interface is a system capable of translating brain activity into commands to control an external device. Situated at the intersection of neuroscience, AI, and digital technology, it represents one of the most direct ways to integrate humans with machines.
Regarding the global BCI market, the total addressable market (TAM) for invasive BCIs was estimated at US$ 168.27 billion in 2025, with a projected compound annual growth rate (CAGR) of 1.52 per cent between 2026 and 2033.
Various studies indicate that invasive BCIs offer greater potential for restoring motor functions and communication abilities in patients suffering from conditions such as amyotrophic lateral sclerosis (ALS), spinal cord injuries, and stroke.
Conversely, regarding non-invasive BCIs, the serviceable obtainable market (SOM) was estimated at US$ 397.59 million in 2025, with a projected compound annual growth rate (CAGR) of 8.73 per cent between 2026 and 2033.
China’s national development strategy, as outlined in its latest five-year plan (2026–2030), has identified BCIs as one of six key sectors for the future.
In July 2025, seven national ministries jointly established guidelines and objectives aimed at fostering a globally competitive BCI industry by 2030.
National regulatory authorities have also accelerated the approval process for devices intended for patients suffering from conditions such as stroke, Parkinson’s disease, Alzheimer’s disease, and spinal cord injuries.
Last March, China approved its first BCI system, designed to help patients with quadriplegia, resulting from cervical spinal cord injuries, regain partial hand function.
According to the national research firm CCID Consulting, the Chinese market is projected to exceed 6 billion yuan (US$ 900 million) by 2028, with an annual growth rate of approximately 18 per cent between 2024 and 2028.
Potential and Critical Issues
BCIs hold enormous potential; according to their developers, they could grant mobility to those who are immobile, a voice to the mute, and hope to those who have none.
At the same time, however, BCIs challenge everything we know about privacy, identity, free will, and the very meaning of what it is to be human, a point acknowledged by experts in the field.
For this reason, the development of neuroscience must be accompanied by legal foresight, helping innovators, regulatory authorities, and the public navigate a future in which the human brain is no longer private by default.
Despite rapid progress, regulation in this sector remains fragmented, outdated, or even non-existent in many jurisdictions.
Most existing regulatory frameworks categorise BCIs either as either medical devices, requiring approval for safety and efficacy, or as consumer electronics, subject only to basic consumer protection laws.
In reality, BCIs introduce entirely new challenges, particularly regarding data privacy, since they end up processing “the person themselves”. The information collected may include thoughts, moods, intentions, or emotional states.
This represents a level of intimacy far greater than that of conventional biometrics; without robust safeguards, BCIs could expose users to unprecedented levels of surveillance, manipulation, or exploitation.
Consequently, analysts and industry experts are calling on policymakers to: establish multi-tiered regulatory classifications based on a device’s level of invasiveness and its intended function; update laws concerning medical devices and data protection to explicitly include neural data; mandate transparency and informed consent for all commercially oriented BCIs; recognise neurorights in national and international law; and, finally, fund public education programmes and interdisciplinary research into the impacts of neurotechnologies.
