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Joint research and application of key technologies for auditory brainstem implantation

Joint research and application of key technologies for auditory brainstem implantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050359
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Interventions

CI:cochlear implantation
ABI:auditory brainstem implantation

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 to 6 years; 2. Children with congenital deafness diagnosed with severe or profound sensorineural hearing loss; 3. Common cavity malformation, cochlear dysplasia, IP-I, or cochlear aperture malformation; 4. ABR was poorer than 90 dBnHL.

Exclusion criteria

Exclusion criteria: 1. No conditions for postoperative auditory and language training; 2. Cannot be regular followed up after surgery; 3. Having serious central nervous system diseases such as white matter dysplasia and epilepsy; 4. With basic diseases that cannot tolerate general anesthesia.

Design outcomes

Primary

MeasureTime frame
Pure tone audiometry (PTA);

Secondary

MeasureTime frame
Speech function (intelligibility);Speech function (MESP);Subjective Scale of Auditory and Speech Function (CAP);Subjective Scale of Auditory and Speech Function (SIR);Subjective Scale of Auditory and Speech Function (MUSS);Subjective Scale of Auditory and Speech Function (IT-MAIS);Development scale (GESELL);

Countries

China

Contacts

Public ContactWang Zhaoyan, Wu Hao

Department of Otolaryngology Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

wzyent@163.com+86 13761000011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026