Patients with severe or profound sensorineural hearing loss in both ears
Conditions
Interventions
Experimental group:Perform cochlear implantation surgery with the assistance of the cochlear implantation surgical navigation system (Model and Specification: SBT-CIR1).
Sponsors
Shandong Second People's Hospital
Eligibility
Sex/Gender
All
Age
7 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The age ranges from 7 to 60 years old. 2. Severe or profound sensorineural hearing loss in both ears. 3. Hearing aids are ineffective or have very poor effects, and the recognition rate of open short sentences under the condition of binaural hearing aid listening (70dBSPL) is <= 50%. 4. Auditory speech is the main way of daily communication. 5. There are no surgical contraindications and no other serious congenital malformations/complications. 6. The subjects have provided the signed informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Allergic to the materials of the implant. 2. Severe inner ear malformations (except congenital cochlear malformations (Mondini) and large vestibular aqueduct syndrome (LVAS)). 3. Deafness is caused by non-cochlear lesions. 4. There is an infection in the middle ear or the tympanic membrane perforation has not healed. 5. Patients with other serious diseases, such as diabetes, heart disease, etc. 6. Those with abnormal brain structures, such as abnormal white matter development, demyelinating diseases, etc. 7. Patients with epilepsy, intellectual disabilities, mental illnesses, scars, and hypersensitive constitutions. 8. Unable to cooperate with audiological evaluations and language training. 9. In poor general physical condition and unable to undergo surgery. 10. Those deemed inappropriate for enrollment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrode implantation depth;The number of correctly inserted electrode contacts.;The success rate and insertion time of cochlear electrode arrays implanted through the drilled direct cochlear access.;The absolute angular accuracy of the drilled tunnel passage; | — |
Countries
China
Contacts
Public ContactXu Lei
Shandong Second People's Hospital
Outcome results
None listed