None
Conditions
Interventions
Observation group:NA
Sponsors
Shu lan(Bo Ao) Hospital
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 12 months or older (at time of surgery). 2. Willing and able to comply with study schedule. 3. Willing and able to provide written informed consent. 4. Surgery performed from 26 January 2025 to the start of this real-world study. 5. Only post-operative imaging that has been conducted will be included in the retrospective study. 6. Only intraoperative test result been saved in the Nucleus SmartNav software will be included in the retrospective study.
Exclusion criteria
Exclusion criteria: 1. Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted. 2. Previous cochlear implantation in the ear to be implanted prior surgery. 3. Unrealistic expectations regarding the possible benefit, risks, and limitations of participating in this study, as determined by the investigator. 4. Any contraindications for cochlear implantation listed in the relevant product physicians guide. 5. Additional disabilities that may affect the participant’s participation or safety during the clinical investigation. 6. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 7. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 8. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator. 9. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging-confirmed placement outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactYuefeng Sun
Shu lan(Bo Ao) Hospital
Outcome results
None listed