Congenital Hearing Loss
Conditions
Interventions
Infants:Bilateral cochlear implantations
Children:Bilateral cochlear implantations
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University, School of Medicine
Eligibility
Sex/Gender
All
Age
0.5 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1) Aged 6-36months; 2) Bilateral profound SNHL diagnosed as follows: click-ABR (auditory brainstem responses): bilateral >=90 dB nHL; DPOAE (distortion product otoacoustic emission): bilateral failed; 3) Normal cochlear anatomy or large vestibular aqueduct syndrome (LVAS) confirmed by computerized tomography (CT) scan and magnetic resonance imaging (MRI); 4) Term newborns with normal weight; 5) Participants living with their parents and having speech rehabilitation after CI; 6) The guardian agrees to participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Mental retardation or autism; 2) White matter disease or demyelinating disease; 3) Middle ear and/or mastoid acute or chronic inflammation; 4) Other contraindications for CI surgery; 5) Unable to return to participating institutions as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gesell Development Diagnosis Scale (GDDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| surgical complication rate;Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS);Categories of Auditory Performance-II (CAP-II);Meaningful Use of Speech Scale (MUSS);Speech Intelligibility Rating (SIR);LittlEARS Auditory Questionnaire (LEAQ);Speech Discrimination Score;Sound Source Localization;Speech Articulation;Verbal Ability Test;Speech Comprehension Test;Musical perception Test; | — |
Countries
China
Contacts
Public ContactHao Wu
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University, School of Medicine
Outcome results
None listed