Patients with severe to profound sensorineural hearing loss
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Under 70 years of age and family members/legal representatives can cooperate to complete the assessment and follow-up; 2.For patients with severe to profound sensorineural hearing loss, unilateral/bilateral CI implantation has been completed, and the implanted devices are commonly compliant products of the country or our hospital; 3.Be willing and able to complete the 0, 1, 3, 6, and 12 month assessments and home exercise records as planned, and be able to use or assist in using the follow-up questionnaire and rehabilitation training system; 4.Patients or their legal representatives provided written informed consent;
Exclusion criteria
Exclusion criteria: 1.Significant cognitive impairment/severe mental disorder, unable to cooperate with behavioral assessment; 2.Severe systemic complications, such as acute cardiovascular and cerebrovascular events and uncontrolled epilepsy, affect the safety of follow-up and the interpretation of results; 3.Recent participation in clinical trials that conflict with the objectives of this study; 4.Other conditions judged by the investigator to be ineligible for enrollment (e.g., very poor follow-up adherence);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in speech recognition accuracy in quiet (binaural/implanted-hearing condition from baseline);The improvement of sound field hearing threshold (0.5/1/2/4 kHz average); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in score on a functional scale (CAP, SIR, or equivalent);Change in sentence/word recognition rate under noise (preset SNR);Processor wear/use time and rehabilitation compliance indicators;Reprogramming needs, adverse events related to rehabilitation were recorded; | — |
Countries
China
Contacts
Shanghai Sixth People’s Hospital