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Nurotron cochlear implant clinical trial (12-71month old)

Nurotron cochlear implant clinical trial(12-71month old)

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TIC-17013858
Enrollment
Unknown
Registered
2017-12-13
Start date
2011-01-05
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

severe or extremely severe sensorineural deafness

Interventions

Case series :Nurotron cochlear implant

Sponsors

Beijing Tong Ren Hospital,CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. After the doctor, rehabilitation and third-party experts technology committee consultation for cochlear implant surgery; 2. Children with legal guardians understand the purpose of this test, agreed to children to participate in this test, and sign the informed consent; 3. 12 ~ 71 months bilateral severe or extremely severe sensorineural deafness patients; 4. Children parents can kindly communicate, and is willing to follow the test requirements, actively complete speech rehabilitation training after surgery.

Exclusion criteria

Exclusion criteria: 1. allergy to implant materials; 2. severe inner ear malformation (MONDINI malformation and large vestibule aqueduct syndrome (LVAS)); 3. deafness is caused by non cochlear lesions. 4. the middle ear was infected or the perforation of tympanic membrane was not healed. 5. patients who had participated in other clinical trials of homemade cochlear cochlear or other cochlear implant patients; 6. suffered from mental illness; 7. patients with other serious diseases, such as heart disease, and so on; 8. the combination of other disabilities; 9. patients with abnormal brain structure (such as abnormal brain white matter development, demyelinating disease, etc.); 10. epileptic patients; 11. patients with cicatricial constitution and susceptibility. 12. patients who were unable to participate in speech rehabilitation training after operation.

Design outcomes

Primary

MeasureTime frame
Speech recognition rate;

Countries

China

Contacts

Public ContactChu Li

Zhejiang Nurotron Biotechnology Co., Ltd.

zhangwei@nurotron.com+86 0571 88179932

Outcome results

None listed

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