Hualing HLK20-1 cochlear implant prospective and multicenter clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900025520

Enrollment

Unknown

Registered

2019-08-31

Start date

2019-09-06

Completion date

Unknown

Last updated

2019-09-02

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

Conditions

deaf

Interventions

Case series:Hualing HLK20-1 cochlear implant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Over 6 years of age (including 6 years old)post-surgical patients, the deafness is not more than 15 years; (2) Severe or extremely severe sensorineural hearing loss; (3) The hearing aid is invalid or has a poor effect. Under the condition of binaural hearing aid (70dBHL), the open sentence recognition rate <=50%; (4) Residual hearing (including drumstick test response, hearing aid test response); (5) The way of daily communication is mainly based on auditory speech; (6) No cochlear implant experience, suitable for implantation of cochlear implant by doctor's diagnosis; (7) No surgical contraindications; (8) High-resolution thin-layer CT of the tibia shows layer spacing of <=2 mm, window width of 3000-4000, and window level of 500-700. It shows that the structure of the inner ear and the inner auditory canal is basically normal, and there are no serious diseases (level position, crown position) of the middle ear, mastoid, and eustachian tube; (9) Agree to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergic to implant materials; (2) Serious inner ear malformation; (3) Deafness caused by the cochlear lesions; (4) The middle ear infection or tympanic membrane perforation were not healed; (5) In other domestic cochlear clinical trials, or other cochlear implant patients; (6) Mental illness; (7) Patients with other severe diseases, such as diabetes or heart disease, etc.; (8) Abnormal brain structure (such as the brain white matter dysplasia, demyelinating disease, etc.); (9) People with epilepsy; (10) Scar constitution and sensitive physical patients.

Design outcomes

Primary

Measure	Time frame
Cochlear implant hearing aid sound field hearing threshold;Speech recognition rate;	—

Countries

China

Contacts

Public ContactFanglu Chi

the EENT Hospital of Fudan University

chifanglu@126.com+86 021-64377134

Outcome results

None listed

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