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Clinical follow-up study of Yuanhang cochlear implant system after marketing

Clinical follow-up study of Norcom Long Voyage Cochlear Implant system after marketing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086315
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Bi-focal and extreme sensorineural deafness

Interventions

Experimental group:Cochlear implant (CS-20A)

Sponsors

301 General Hospital of the PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patients under 7 years old were 12-83 months old, and the patients over 7 years old were 7 years old or older with bifocal and extremely severe sensorineural deafness; 2. Extreme deafness is less than 15 years old; 3. Wearing hearing AIDS has limited or no effect; 4. Audiological assessment and imaging assessment meet the requirements; 5. No contraindications to surgery or other severe congenital malformations; 6. The doctor diagnosed it as suitable for cochlear implant surgery; 7. There are conditions for hearing and speech rehabilitation education; 8. Smooth communication in Mandarin (Age 7 +); 9. Agreed to participate in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergic to the implant material; 2. Severe inner ear deformity (except MONDINI deformity and large vestibular aquaqual syndrome (LVAS)); 3. Deafness caused by non-cochlear lesions (e.g.retrocochlear lesions, auditory neuropathy); 4. Middle ear infection or unhealed tympanicmembrane perforation; 5. Suffer from mental retardation; 6. Suffer from mental illness; 7. The general condition is poor, unable to accept surgery; 8. Abnormal brain structure (such as abnormal white matter development, demyelination disease, etc.); 9. Uncontrollable seizures; 10. Patients who do not understand the benefits and risks of cochlear implants and have unreasonable expectations; 11. Those who were assessed as unsuitable for inclusion by the researcher; 12. It doesn't fit all the tests.

Design outcomes

Primary

MeasureTime frame
Overall therapeutic efficiency;

Secondary

MeasureTime frame
Auditory ability assessment;Verbal ability assessment;Acoustic field threshold assessment;Speech recognition rate of MSP monosyllabic group in quiet age over 7 years;Speech recognition rate of MSP sentences under noise (SNR +10 dB) over 7 years old;

Countries

China

Contacts

Public ContactYang Shiming

301 General Hospital of the PLA

lvmt801@163.com+86 135 5256 4506

Outcome results

None listed

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