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Canceled by the investigator. Clinical Trials of Cochlear Implant Systems

Clinical Trials of Cochlear Implant Systems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067092
Enrollment
Unknown
Registered
2022-12-27
Start date
2017-12-28
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 Technolog (Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Prelingual deaf patients aging from 12 months to 6 years old (excluding 6 years old); 2. Severe or profound sensorineural hearing loss in both ears; 3. The lesion is located in the cochlea; 4. Severe deaf patients with ineffectiveness or unsatisfying performance wearing hearing aids for 3-6 months (patients with profound deafness may consider cochlear implantation directly); 5. No experience of cochlear implantation, and have been diagnosed by a doctor as suitable for a cochlear implant; 6. No surgical contraindications; 7. Have a correct understanding and appropriate expectations of cochlear implants; 8. Possess the conditions for auditory and speech rehabilitation education; 9. Agree to participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Contraindications to cochlear implant surgery; 2. Deafness caused by non-cochlear pathology; 3. Severe deformity of the inner ear, such as Michel deformity or absence of the cochlea; 4. Absence or interruption of the auditory nerve; 5. Acute suppurative inflammation of the mastoid of the middle ear; 6. Frequent seizures of epilepsy that cannot be controlled; 7. Severe mental, intellectual, behavioral and psychological disorders, unable to cooperate with auditory and speech training; 8. Those with other symptoms who are not suitable for cochlear implant surgery.

Design outcomes

Primary

MeasureTime frame
Acoustic field hearing threshold;Subjective questionnaire;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 6, 2026