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Supervion of pressure changes and establishment of digital models during cochlear implantation based on inner ear micropressure measurement techology

Supervion of pressure changes and establishment of digital models during cochlear implantation based on inner ear micropressure measurement techology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110261
Enrollment
Unknown
Registered
2025-10-11
Start date
2025-03-29
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural hearing loss

Interventions

Test group:Performing cochlear implant surgery under pressure monitoring
Control group:Performing cochlear implant surgery without pressure monitoring

Sponsors

Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 55 Years

Inclusion criteria

Inclusion criteria: For patients with severe or extremely severe sensorineural hearing loss in both ears, wearing high-power hearing aids is ineffective or minimally effective. If the diagnosed lesion is located in the cochlea, cochlear implantation can be chosen.

Exclusion criteria

Exclusion criteria: Cochlear implants use electrical stimulation of the auditory nerve to enable patients to perceive sound. They are mainly suitable for cochlear hearing loss and not for cochlear posterior hearing loss; The degree of hearing loss is severe and extremely severe deafness. (1) Absolute contraindications 1. Severe deformities of the inner ear caused by cochlear and auditory nerve factors, such as Michael malformation, cochlear absence malformation, etc; The diameter of the internal auditory canal is less than 2mm. 2. Cochlear fracture is likely to damage the vestibular cochlear nerve, rendering cochlear implantation ineffective. Therefore, cochlear fracture causing damage to the auditory nerve is a contraindication for cochlear implantation surgery. 3. Electrical stimulation for mental illness may stimulate the cerebral cortex, so patients with epilepsy, severe intellectual disabilities, and cerebral palsy are all contraindications for cochlear implant surgery. 4. Other surgical contraindications are present, and cochlear implantation is not considered. (2) Relative contraindications 1. Middle ear infection factors: For patients with suppurative otitis media, implanting electrodes can bring the infection into the inner ear, which is very dangerous. If you want to implant a cochlear implant, you can completely remove the otitis media lesion through staged surgery before implanting the cochlear implant. 2. Unable to cooperate with language trainers or have insufficient family finances to sustain the daily use of cochlear implants. 3. If the general condition of the body is poor and can be recovered after treatment, surgery can be postponed.

Design outcomes

Secondary

MeasureTime frame
One month postoperative residual hearing;

Primary

MeasureTime frame
Pressure of extracochlear lymphatic fluid;

Countries

China

Contacts

Public ContactYang Shiming

Chinese PLA general hospital

yangshiming@301hospital.com.cn+86 137 0139 3529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026