10月20日，国家药品监督管理局正式发布，批准“听觉脑干植入体”创新产品注册申请。这款由上海交通大学医学院附属第九人民医院吴皓教授团队与浙江诺尔康神经电子科技股份有限公司合作研发的国内首创有源Ⅲ类植入器械“听觉脑干植入体”，是我国第一个在颅内中枢进行电刺激和神经信号提取的产品。
On October 20, the National Medical Products Administration officially announced approval of the "auditory brainstem implant" innovative product registration application. This domestically pioneered active Class III implantable device, jointly developed by Professor Wu Hao's team at Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital and Zhejiang Nurotron Neuroelectronic Technology Co., Ltd., is China's first product to perform electrical stimulation and neural signal extraction in the intracranial center.
临床上有一类患者，内耳严重畸形或蜗神经缺如，人工耳蜗无能为力。听觉脑干植入体将电极阵列植入脑干耳蜗核表面，绕过耳蜗和听神经，直接刺激中枢听觉感受神经元产生听觉，是一种感觉重建的侵入式脑机接口装置。正因为它作用于脑干这一生命中枢，手术难度极高，长期制约着该技术向国内引进和普及。
Clinically, there is a group of patients with severe inner ear malformation or cochlear nerve absence for whom cochlear implants cannot help. The auditory brainstem implant places an electrode array on the surface of the cochlear nucleus in the brainstem, bypassing the cochlea and auditory nerve to directly stimulate central auditory sensory neurons to produce hearing—an invasive BCI device for sensory reconstruction. Precisely because it acts on the brainstem, the vital center, surgical difficulty is extremely high, long constraining the technology's introduction and popularization in China.
2024年，吴皓教授组建的医工交叉攻关团队完成全部听觉脑干植入手术和随访，开机后12个月治疗总有效率达到96.67%，标志着国产人工听觉脑干技术的临床试验取得圆满成功。近日，诺尔康-WH-01A听觉脑干植入体成为国内第一个获得国家药监局创新器械注册申请批准的听觉神经接口产品。这一产品解决的，是先天性耳聋干预“最后一公里”中最难的问题。它也是国内首个进入脑干刺激领域的国产植入装置。
In 2024, Professor Wu Hao's medical-engineering interdisciplinary team completed all auditory brainstem implant surgeries and follow-ups, with total treatment effectiveness reaching 96.67% at 12 months after activation, marking the successful clinical trial of domestic auditory brainstem technology. Recently, Nurotron-WH-01A auditory brainstem implant became China's first auditory neural interface product approved under NMPA's innovative device registration application. What this product solves is the hardest problem in the "last mile" of congenital deafness intervention. It is also China's first domestic implantable device entering the brainstem stimulation field.
这件事放在前面讨论的脑机接口产业脉络里，有几个点值得对照。前面讨论过武汉把三条脑机接口技术路线都做出了临床案例，光谷国际脑机接口创新中心一栋楼里塞进了从电极到整机的上下游企业，也讨论过清华洪波教授预测脑机接口的GPT时刻在2030年，超声脑机、侵入式脑机都在往前推进。诺尔康这款产品的特殊性在于，它既不是超声脑机这种非侵入式路线，也不是运动脑机接口这种解码运动意图的路线，而是感觉重建，用侵入式装置直接刺激脑干，让患者产生听觉。这个定位和前面讨论的凯瑞医疗智能采血机器人、MMI显微外科机器人、Butterfly Network超声脑机是同一个方向，都是在医疗场景里用机器人或脑机接口技术解决具体的临床问题。
Placed in the BCI industry thread discussed earlier, several points deserve comparison. Earlier we discussed Wuhan producing clinical cases across all three BCI technical routes and the Optics Valley International BCI Innovation Center packing upstream and downstream enterprises from electrodes to complete machines into one building. We also discussed Tsinghua Professor Hong Bo predicting BCI's GPT moment in 2030, with ultrasound BCI and invasive BCI both advancing. Nurotron's product is special in that it is neither a non-invasive route like ultrasound BCI nor a motor BCI route decoding movement intentions, but sensory reconstruction—using an invasive device to directly stimulate the brainstem so patients can hear. This positioning aligns with the previously discussed Kairui Medical intelligent blood collection robot, MMI microsurgery robot, and Butterfly Network ultrasound BCI—all using robots or BCI technology to solve specific clinical problems in medical scenarios.
这款产品获批的意义，还在于它补上了先天性耳聋干预链条里最难的一段。前面讨论过人工耳蜗是脑机接口领域商业化最成熟的品类之一，全球装机量以数十万计。但人工耳蜗有一个前提，蜗神经必须完好。对于内耳严重畸形或蜗神经缺如的患者，人工耳蜗这条路走不通。听觉脑干植入体绕过了耳蜗和听神经，直接在脑干耳蜗核上做刺激，等于把人工听觉的适应人群从蜗神经完好的患者扩展到了蜗神经缺如的患者。这个扩展在临床上意义很大，因为这类患者过去没有有效的听觉重建手段。
The significance of this product's approval also lies in filling the hardest gap in the congenital deafness intervention chain. Earlier we discussed that cochlear implants are one of the most commercially mature categories in BCI, with global installations in the hundreds of thousands. But cochlear implants have a prerequisite—the cochlear nerve must be intact. For patients with severe inner ear malformation or cochlear nerve absence, the cochlear implant path does not work. The auditory brainstem implant bypasses the cochlea and auditory nerve, stimulating directly on the brainstem cochlear nucleus, effectively expanding the eligible population for artificial hearing from patients with intact cochlear nerves to those with absent cochlear nerves. This expansion is clinically significant because these patients previously had no effective hearing reconstruction method.
这款产品的获批，也和前面讨论的医疗器械审批节奏对得上。前面讨论过凯瑞医疗的智能采血机器人拿到第三类医疗器械注册证，也讨论过国宇星辰进入国家级卫星互联网星座运营商供应商名录。医疗器械的审批周期长、门槛高，尤其是三类有源植入器械，需要经过严格的临床试验和审评。诺尔康-WH-01A从临床试验到获批，走的是创新器械注册申请通道，这个通道本身就是为国内首创、临床急需的产品设置的。它获批的意义，不只是多了一款产品，而是国内脑机接口产业在侵入式感觉重建这个细分方向上，有了第一个拿到注册证的国产装置。这个起点能不能带动更多产品跟进，取决于后续的临床推广、医生培训、支付覆盖这些环节能不能跟上。
The product's approval also aligns with the medical device approval rhythm discussed earlier. Earlier we discussed Kairui Medical's intelligent blood collection robot obtaining Class III medical device registration certification, and Guoyu Xingchen entering the supplier list of a national satellite internet constellation operator. Medical device approval cycles are long with high thresholds, especially Class III active implantable devices, requiring rigorous clinical trials and review. Nurotron-WH-01A from clinical trial to approval took the innovative device registration application channel, a channel itself set up for domestically pioneered, clinically urgent products. The significance of its approval is not just one more product but that China's BCI industry now has its first domestically registered device in the invasive sensory reconstruction niche. Whether this starting point can drive more products to follow depends on whether subsequent clinical promotion, physician training, and payment coverage can keep pace.
