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Retrospective analysis to evaluate the efficacy and safety of cochlear implants for severe or profound severe sensorineural deafness in both ears

Retrospective analysis to evaluate the efficacy and safety of cochlear implants for severe or extremely severe sensorineural deafness in both ears

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087194
Enrollment
Unknown
Registered
2024-07-22
Start date
2023-04-12
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Severe to profound sensorineural deafness in both ears

Interventions

Case series (cochlear implant):None

Sponsors

Boao Super Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 56 Years

Inclusion criteria

Inclusion criteria: Subjects were enrolled in the "An open single-arm clinical study to evaluate the safety and efficacy of cochlear implant in the treatment of severe or profound severe sensorineural hearing loss in both ears" and had a follow-up period of at least 11 months.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
The hearing threshold with CI in sound field;The verbal recognition rate of open monosyllabic words, two-syllable and short sentences in quiet environment;Subjective questionnaire: ITMAIS for patients under 3 years old (excluding 3 years); MAIS for those aged 3-6 years (including 3 years);—

Secondary

MeasureTime frame
20% improvement in verbal recognition rate compared with preoperative level using hearing aid;20% improvement in verbal recognition rate compared with preoperative level using cochlear hearing assistance;—

Countries

China

Contacts

Public ContactXiguang Tian

Boao Super Hospital

707654700@qq.com+86 898 6298 8023

Outcome results

None listed

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