Sensorineural hearing loss
Conditions
Interventions
The observation group of sensorineural hearing loss:None
Sponsors
Shulan (Boao) Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 12 months or above (at the time of surgery) 2. Willing and able to follow the research plan. 3. Willing and able to provide a written informed consent form. 4. The surgery will take place from January 26, 2025 to the period when this real-world study begins. 5. This retrospective study will only include implanters who have undergone post-operative imaging examinations. 6. This retrospective study will only include implanters whose intraoperative examination results have been saved in the Nucleus SmartNav software.
Exclusion criteria
Exclusion criteria: 1. There may be ossification, otosclerosis, deformity or any other cochlear abnormalities (such as a common cavity) that could prevent the complete implantation of the electrode array in the target ear. 2. The target ear has previously undergone cochlear implant surgery. 3. Unrealistic expectations regarding the potential benefits, risks and limitations of participating in this study are determined by the researchers. 4. Any contraindications for cochlear implantation as listed in the relevant product doctor's guidelines. 5. Other defects that may affect the subject's participation in the study or safety during the clinical research. 6. Unable or unwilling to comply with the clinical research requirements determined by the researchers. 7. Center staff directly related to this study and/or their immediate family members; immediate family members refer to spouse, parents, children or siblings. 8. Employees of Cochlear or employees of the contract research organization or contractor hired by Cochlear for this study purpose, determined by the researchers. 9. Currently participating or having participated in another interventional clinical study/ trial involving investigational drugs or devices within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of system location check; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events and device defects; | — |
Countries
China
Contacts
Public ContactSun Yuefeng
Shulan (Boao) Hospital
Outcome results
None listed