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Post-market clinical follow-up study of Nurotron Voyager Cochlear Implant System

Post-market clinical follow-up study of Nurotron Voyager Cochlear Implant System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065880
Enrollment
Unknown
Registered
2022-11-17
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

deaf

Interventions

Group of 7 years old below: Cochlear implant
Group of 7 years old and above:Cochlear implant

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The group under 7 years old was 12-83 months, and the group over 7 years old was 7 years old or more with bilateral severe and extremely severe sensorineural hearing loss; 2. Severe deafness shall not exceed 15 years; 3. The effect of wearing hearing aids is limited or invalid; 4. Audiology evaluation and imaging evaluation meet the requirements; 5. No surgical contraindication or other serious congenital malformation; 6. It is suitable for cochlear implantation according to the doctor's diagnosis; 7. There are conditions for hearing and language rehabilitation education; 8. Smooth communication in Putonghua (the group over 7 years old); 9. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to implant materials; 2. Serious inner ear malformation (except MONDINI malformation and large vestibular aqueduct syndrome (LVAS)); 3. Deafness is caused by non cochlear diseases (such as retrocochlear diseases and auditory neuropathy); 4. The middle ear has infection or tympanic membrane perforation has not healed; 5. Have mental retardation; 6. Suffering from mental illness; 7. The general condition of the body is poor and the patient cannot accept surgery; 8. Those with abnormal brain structure (such as abnormal white matter development, demyelinating disease, etc.); 9. Uncontrolled epilepsy; 10. Patients who do not understand the benefits and risks of cochlear implants and whose expectations are unreasonable; 11. Those who are not suitable for enrollment after evaluation by the researcher; 12. Unable to cooperate with all tests.

Design outcomes

Primary

MeasureTime frame
Aided hearing thresholds;sentence speech recognition score;Meaningful Auditory Integration Scale (IT-MAIS/MAIS);

Secondary

MeasureTime frame
monosyllabic word recognition score;sentence speech recognition score in noise;

Countries

China

Contacts

Public ContactYang Shiming

Chinese PLA General Hospital

yangsm301@263.net+86 13701393529

Outcome results

None listed

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