China approves its first home-grown brainstem hearing implant for children

By Inside BCI · Edited by Velco Dar · October 26, 2026

Some children are born deaf in a way a cochlear implant cannot fix. A cochlear implant stimulates the hearing nerve from inside the inner ear. When the inner ear is badly malformed, or the hearing nerve never formed, the implant has nothing to work through. For these children, surgeons can place a small electrode pad on the brainstem instead. On 19 October China’s medical device regulator approved the first such device made in China, and announced it the next day.

What was approved

The National Medical Products Administration (NMPA) approved Zhejiang Nurotron’s WH-01A auditory brainstem implant through its special review procedure for innovative devices, under registration number 20263122152. It is an active Class III implant, China’s highest-risk device category, and the 447th product approved through that procedure since the first in December 2014. The approval covers children aged 2 to under 6 who were deaf before learning to speak, whose deafness is not caused by a tumour or part of a wider syndrome, and who cannot receive a cochlear implant because of a severe inner-ear malformation or a missing cochlear nerve.

The implant stimulates the cochlear nucleus, the part of the brainstem where the processing of sound begins, and works with the speech processor of Nurotron’s cochlear implants. Nurotron says its 16 electrodes sit on a pad of 5.5 by 3.5 millimetres. The regulator calls it China’s first product that both stimulates and records neural signals in the brainstem, and Wu Hao’s team says it uses a coding strategy built for the four tones of Mandarin.

How it was developed

The device came from a team led by Wu Hao, a professor of otolaryngology at Shanghai Ninth People’s Hospital, part of Shanghai Jiao Tong University School of Medicine, who was the hospital’s president until January 2026. The hospital carried out mainland China’s first series of children’s auditory brainstem implants in 2019, using imported devices. In July 2021 the team licensed its patents to Nurotron and its wholly owned subsidiary Shanghai Hansheng Medical. The first operation with the Chinese device took place in January 2022.

The registration trial enrolled 30 children and finished in 2024. The developers report an overall effectiveness rate of 96.67 per cent 12 months after the implants were switched on, without saying how effectiveness was measured. The trial’s results have not been published as a peer-reviewed paper of their own. A 2025 paper by Wu Hao’s team in Advanced Science included 30 children given the WH-01A among 112 children implanted at the hospital between 2019 and 2023, and did not report their outcomes separately.

Nurotron, based in Hangzhou, has sold cochlear implants since its first approval in China in 2011 and has said it holds about a fifth of the Chinese market. In 2021 the team said a Chinese brainstem implant would cost about a third as much as an imported one. Wu Hao said in 2023 that the imported device alone cost nearly 400,000 yuan per operation and that families paid for brainstem implants entirely themselves, while disability federations and charities covered most of the cost of cochlear implants.

Why it matters

Auditory brainstem implants are not new. Surgeons at the House Ear Institute in Los Angeles performed the first in 1979, and more than 1,000 people worldwide have received one. The US Food and Drug Administration approved Cochlear’s device in 2000 for patients aged 12 and over with neurofibromatosis type 2, a genetic condition that causes benign tumours on the nerves for hearing and balance, usually on both sides. That remains the only approved indication in the US. Implants for young children with missing cochlear nerves or malformed inner ears are still investigational there, studied in a trial at NYU Langone Health that is recruiting. In Europe, MED-EL’s implant has carried CE marking, the European market approval, for children from 12 months since 2017.

China’s approval covers young children whose deafness is not caused by tumours, a group the US label does not cover. It also fits China’s push to build its own neurotechnology industry. The national plan for brain-computer interfaces, issued in July 2025 by the Ministry of Industry and Information Technology and six other government bodies, names cochlear implants among the mature products to improve. It also calls for multichannel systems that detect and stimulate neural signals in the visual and auditory cortex; the brainstem implant works lower in the hearing pathway. Wu Hao’s team and Chinese media describe the implant as an invasive brain-computer interface for restoring a sense. The regulator’s notice describes it as an auditory brainstem implant. Through the same procedure, the regulator approved Neuracle’s implantable brain-computer interface system for restoring hand movement, China’s first, on 13 March.

How many children could benefit is uncertain. Nurotron and Wu Hao’s team put the share of children with severe congenital deafness who cannot receive a cochlear implant, because of severe malformations of the cochlea or hearing nerve, at about 8 per cent. In 2025 Wu Hao said 1,000 to 2,000 of the roughly 10,000 infants in China who need a hearing implant each year cannot use a cochlear implant. A 2015 US study roughly estimated that 2.1 per cent of children who might need a hearing implant were born without a cochlea or a cochlear nerve on both sides, the clearest case for a brainstem implant.

Not disclosed

Nurotron has not announced a price, a launch date or whether the implant will be covered by China’s public health insurance. The developers have not published the trial’s hearing and speech outcomes or explained how the 96.67 per cent figure was calculated.

What to watch

Whether the registration trial’s results appear in a peer-reviewed journal, with hearing and speech outcomes.

Whether the price comes in at the third of the imported cost that the team forecast in 2021, and whether public insurance covers it.

Whether Nurotron, which registered with the Zhejiang office of the China Securities Regulatory Commission in November 2024 to begin preparing for a share listing, files for one.

Whether the FDA approves a brainstem implant for young children whose deafness is not caused by tumours.

Sources

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news China NMPA Nurotron auditory-brainstem-implant Wu-Hao Shanghai-Ninth-Peoples-Hospital hearing neuroprosthetics cochlear-implant paediatric Neuracle