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Canceled by the investigator. Clinical Validation of Cochlear Implant System

Clinical Validation of Cochlear Implant System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067091
Enrollment
Unknown
Registered
2022-12-27
Start date
2016-01-28
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

deaf

Interventions

Sponsors

Huazhong University of Science and Technology (Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 68 Years

Inclusion criteria

Inclusion criteria: 1. Postlingual deaf patients over 6 years old (including 6 years old) with speech function; 2. Severe or profound sensorineural hearing loss in both ears; 3. The lesion is located in the cochlea; 4. Very poor effect of rehabilitation training with suitable hearing aids for =3 months; 5. No experience in cochlear implantation, suitable for cochlear implantation after diagnosis by a doctor; 6. No surgical contraindications; 7. Have a correct understanding and appropriate expectations of cochlear implants; 8. Have the conditions for hearing and speech rehabilitation education; 9. Agree to participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to the material of the implant; 2. Deafness caused by non-cochlear lesions; 3. Severe deformity of the inner ear (except for vestibular aqueduct enlargement); 4. Lack of auditory nerve; 5. Intellectual disability; 6. Mental illness; 7. Those who cannot cooperate with audiology assessment and language training; 8. Those with acute or chronic inflammation of the mastoid of the middle ear and those with unhealed tympanic membrane perforation; 9. Abnormal brain structure (such as abnormal white matter development, demyelinating disease, etc.); 10. Poor general condition of the whole body; 11. Uncontrolled epilepsy; 12. Those who has unrealistic expectations about the benefits, risks, and limitations associated with surgical procedures and therapeutic instruments; 13. Those who are pregnant or breastfeeding, or who are planning to become pregnant; 14. Those with other symptoms who are not suitable for cochlear implant surgery.

Design outcomes

Primary

MeasureTime frame
Cochlear implant hearing aid sound field hearing threshold;Speech recognition rate;

Secondary

MeasureTime frame
Evaluation of cochlear implant performance by doctors;

Countries

China

Contacts

Public ContactWeijia Kong

Huazhong University of Science and Technology (Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology)

entwjkong@hust.edu.cn+86 27 8572 6114

Outcome results

None listed

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