Nurotron WH-01A auditory brainstem implant (Shanghai Ninth People's Hospital)
- Record ID
- BTSD-ACAD-0092
- Reviewed
- 2026-10-09
- Interface
- other
- Evidence stage
- human
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Nurotron WH-01A auditory brainstem implant (Shanghai Ninth People’s Hospital)
Company brief: Zhejiang Nurotron. General class entry: Auditory brainstem implant.
Specifications below are Nurotron’s own statements unless marked otherwise. Neither company page nor the hospital release links a peer-reviewed engineering paper.
Identity
| Field | Value and source scope |
|---|---|
| Device | Implant with an intracranial electrode paddle, plus an external speech processor (the cochlear-implant processor is stated to be compatible) [1] |
| Model | WH-01A; the first-patient model is called WH-01A (SD) [1][2] |
| Origin | Wu Hao’s team at Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, with Nurotron [1][2][3] |
| Interface class | Paddle array on the cochlear nucleus of the brainstem [1] |
| Regulatory status | NMPA innovative-device special review notice 2024 No. 3 published March 15, 2024 lists the project (per Nurotron; the notice itself was not opened). ChiCTR2300070545 registers a phase III trial in NF2 patients [1][4] |
Geometry and architecture
| Field | Value and source scope |
|---|---|
| Electrode count | 16, giving 16-channel stimulation [1] |
| Array area | 5.5 x 3.5 mm plane [1] |
| Carrier | Biocompatible silicone shaped to the cochlear nucleus [1] |
| Positioning aid | A 3D positioning ridge on the array designed from mock surgery; 16-contact layout matched to cochlear nucleus anatomy and physiology (hospital release) [3] |
Electronics and robustness (company claims)
| Field | Value and source scope |
|---|---|
| Impact resistance | 2.5 J [1] |
| Hermeticity | Leak rate not above 5 x 10^-9 Pa·m3/s, citing EN 45502-2-3 [1] |
| Lifetime | Product life stated above 80 years [1] |
| Stimulation chip | Patented licensed chip with high stimulation rate and three safety layers; impedance measurement and wireless neural telemetry [1] |
| Intraoperative aid | Electrically evoked auditory brainstem response for locating the cochlear nucleus [1][3] |
Clinical and licensing history
| Date | Event |
|---|---|
| February 2019 | Wu Hao’s team performs the first ABI in mainland China using an imported device; 34 operations by July 2021, with auditory and speech recognition in children afterward [3] |
| July 8, 2021 | Hospital reports transfer of the domestic ABI by patent license to a company named Shanghai Hansheng Medical Technology (上海汉声医疗科技有限公司) [3] |
| 2021 | Domestic WH-01A (SD) developed and tested in animals, including non-human primates [1][3] |
| January 26, 2022 | First domestic ABI implanted in a 5-year-old with bilateral cochlear nerve hypoplasia and narrow internal auditory canals; switched on March 1, 2022 [1][2] |
The licensee differs between sources: the hospital names Shanghai Hansheng Medical Technology in 2021, while Nurotron says it co-developed and commercializes the device. The relationship between those companies is not stated in the sources read, so both are shown.
Limits
No impedance, charge limits or outcome data are published in the sources read. “Third maker worldwide” and “first domestic” are Nurotron’s claims; the hospital release says only two comparable devices existed (Australia and Austria).
References
- Nurotron (Chinese), 首个国产人工听觉脑干植入体（ABI）进国家药监局创新器械审查, 20 March 2024.
- Nurotron (Chinese), 首例诺尔康新型听觉脑干植入（ABI）用户顺利开机, 1 March 2022.
- Shanghai Jiao Tong University News (Chinese), 听觉脑干植入系统不再依赖进口, 13 July 2021.
- ChiCTR2300070545.