Non-symdromic and non-tumor induced prelingual hearing loss
Conditions
Interventions
Auditory Brainstem Implantation group:No
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Prelingual hearing loss patients aged 1-6 years (excluding 6 years old); 2. Non-syndromic hearing loss; 3. Non-tumor related hearing loss; 4. Patients with inner ear malformations unable to undergo cochlear implantation (michel deformity, rudimentary otocyst, cochlear aplasia, etc.); or severe inner ear malformations (cochlear malformation, cochlear dysplasia, common cavity, IP-I) with no auditory and speech development after cochlear implantation (>= 12 months); 5. Meet audiology evaluation and imaging evaluation criteria; 6. No surgical contraindications and other severe congenital malformations/complications; 7. Consist of conditions for hearing and speech rehabilitation education; 8. Agree to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to the implant material; 2. Intellectual disability; 3. Mental illness; 4. Unable to cooperate with audiology assessment and language training; 5. Brain tissue structure abnormality that affects implantation surgery or postoperative assessments; 6. Patients who need to undergo follow-up radiotherapy at the brain stem; 7. Poor general health condition and unable to undergo surgery; 8. Uncontrollable epilepsy; 9. Unsuitable for inclusion after evaluation of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Speech recognition evaluation;Electrophysiological assessment;Electrode placement evaluation;Device condition;Adverse event rate; | — |
Countries
China
Contacts
Public ContactWu Hao
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed