Severe to profound sensorineural deafness in both ears
Conditions
Interventions
experimental group:cochlear implant
Sponsors
Hainan Boao Super Hospital Co., Ltd.
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) For patients aged 12 months or above; 2) Binaural severe or profound sensorineural deafness; 3) The subjects can understand the purpose of the study, voluntarily participate in and sign the informed consent; 4) The subjects are willing to complete the follow up and evaluation according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1) Deafness caused by damage to auditory nerve or central auditory channel; 2) Active inflammation of the outer or middle ear; 3) Cochlea ossification, which cannot be implanted with electrodes; 4) Incomplete cochlea development; 5) Tympanic membrane perforation caused by recurrent otitis media; 6) Patients with mental disorders or mental retardation; 7) Patients who were not considered suitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hearing threshold with CI in sound field (0.5, 1.0, 2.0 and 4.0 kHz);The verbal recognition rate of open monosyllabic words, two-syllable and short sentences in quiet environment;Subjective questionnaire: ITMAIS for patients under 3 years old (excluding 3 years); MAIS for those aged 3-6 years (including 3 years); | — |
Secondary
| Measure | Time frame |
|---|---|
| 20% improvement in verbal recognition rate compared with preoperative level using hearing aid;Doctors’ evaluation of the performance of cochlear implants, such as implant thickness, electrode flexibility, easiness of implantation, and electrode vulnerability and so on.;The incidence of adverse events or complications; | — |
Countries
China
Contacts
Public ContactJing Zhang
Hainan Boao Super Hospital Co., Ltd.
Outcome results
None listed