conductive or mixed deafness
Conditions
Interventions
Single-arm Group: Treatment:BHS implantation
Sponsors
Ophthalmology and ENT Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. patients aged 6 years and above; 2. patients with conductive or mixed deafness, which for the ear of applicable side, it's =45 dbHL that the average value of pure tone bone-conduction (PTA) test under 0.5, 1, 2, 3 Hz, while it's =30 dB that the difference between bone-conduction PTA and air-conduction PTA; 3. patients who are diagnosed by the physician to be suitable to wear the bone-conduction hearing system (BHS); 4. patients who will participate in this trial, and they themselves or their legal guardian volunteer to sign the inform consent form (ICF); 5. patients who could communicate well with the investigators, and be able to comply with the requirement of this trial.
Exclusion criteria
Exclusion criteria: 1. a material allergy to the implant; 2. combined with surgical contraindication or inability to tolerate surgery; 3. psychosis, autistic patients; 4. pregnant and lactating women; 5. participants in other clinical studies who did not reach the primary endpoint; 6. To be considered any reason that not suitable for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined effectiveness of SRT and SFA via 0 degree; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of SRT via 90 degree;Effectiveness of SRT via 270 degree;Stability of BHS;Rate of successful implantation of BHS; | — |
Countries
China
Contacts
Public ContactDr. Zhang Tianyu
Ophthalmology and ENT Hospital affiliated to Fudan University
Outcome results
None listed