severe or extremely severe sensorineural deafness
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. After the doctor, rehabilitation and third-party experts technology committee consultation for cochlear implant surgery; 2. Children with legal guardians understand the purpose of this test, agreed to children to participate in this test, and sign the informed consent; 3. 12 ~ 71 months bilateral severe or extremely severe sensorineural deafness patients; 4. Children parents can kindly communicate, and is willing to follow the test requirements, actively complete speech rehabilitation training after surgery.
Exclusion criteria
Exclusion criteria: 1. allergy to implant materials; 2. severe inner ear malformation (MONDINI malformation and large vestibule aqueduct syndrome (LVAS)); 3. deafness is caused by non cochlear lesions. 4. the middle ear was infected or the perforation of tympanic membrane was not healed. 5. patients who had participated in other clinical trials of homemade cochlear cochlear or other cochlear implant patients; 6. suffered from mental illness; 7. patients with other serious diseases, such as heart disease, and so on; 8. the combination of other disabilities; 9. patients with abnormal brain structure (such as abnormal brain white matter development, demyelinating disease, etc.); 10. epileptic patients; 11. patients with cicatricial constitution and susceptibility. 12. patients who were unable to participate in speech rehabilitation training after operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Speech recognition rate; | — |
Countries
China
Contacts
Zhejiang Nurotron Biotechnology Co., Ltd.