Bilateral moderate sloping to profound hearing loss
Conditions
Interventions
Experimental group:Cochlear Nucleus CI632 Profile Plus Implant with Slim Modiolar electrode
Sponsors
Boao Super Hospital
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all the inclusion criteria described below to be eligible for this clinical investigation: 1. Individuals aged 12 months and older at the time of consent with bilateral moderate sloping to profound sensorineural hearing loss. 2. Subjects identified as candidates for the CI632 at the Boao Super Hospital in Hainan Province. 3. Willing and able to provide written informed consent. For children, an authorised parent or guardian will provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation. 1. Medical or psychological conditions that contraindicate undergoing cochlear implantation. 2. Evidence of retrocochlear conditions. 3. Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator. 4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling. 5. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator. 6. Additional disabilities that may affect the subjects participation or safety during the clinical investigation. 7. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 8. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure-tone average aided thresholds (PTA4: 500,1000, 2000, and 4000 Hz) in the sound field at 6 months postactivation.;Safety will be measured by the incidence and severity of adverse events related to the device and program, as well as any serious adverse events unrelated to the device or program; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pure-tone average aided thresholds (PTA4: 500,1000, 2000, and 4000 Hz) in the sound field at 6 months postactivation.;Subjective functional performance questionnaires (IT-MAIS)/MAIS/(SSQ-12 adults/SSQ-P parents);Evaluating Surgeons' Satisfaction with CI632 Implants through Surgeon Surveys; | — |
Countries
China
Contacts
Public ContactXiguang Tian
Boao Super Hospital
Outcome results
None listed