NCT07821281

Brief Summary

Cochlear implantation is an effective intervention for patients with severe to very severe sensorineural hearing loss. By the beginning of 2026, the total number of cochlear implants in China was about 180000. According to the World Health Organization (WHO) survey and data released by the National Bureau of Statistics of China, it is estimated that China's population with severe hearing loss is about 11 million, and the penetration rate is only 1.55. Among them, the adult penetration rate is particularly insufficient, which is far lower than the level of developed countries. In recent years, policy dividends have been intensively introduced in various parts of China. With the update of the rehabilitation service catalog, the price of a single set of cochlear implants in China has plummeted, and cochlear implants have progressed rapidly. At this historical turning point, a systematic analysis of the epidemiology of cochlear implants in my country Characteristics, policy effects and health economics benefits are of great significance for optimizing resource allocation and formulating national hearing care strategies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1995

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
31.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

31.5 years

First QC Date

July 17, 2026

Last Update Submit

September 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Trends in disease burden of severe/very severe deafness in China and provinces

    Based on the data of Chinese cochlear implants, combined with the population with severe hearing loss, the total penetration rate of cochlear implants in China and the trend of changes over the years were calculated. The patients were grouped according to the age at the time of operation.The proportion of each age group in the total population, the change trend of age distribution and gender distribution characteristics were calculated respectively. To construct the medical flow of patients in the provinces of household registration and surgery, Compare the changes in the provincial retention rate and cross-provincial flow of cochlear surgery in China and provinces before and after the collection and medical insurance policy. Set different cochlear implant coverage scenarios, calculate the new demand for the number of surgeries currently completed under the target, quantify the potential service gap, and provide a preliminary planning reference for future cochlear implant services.

    from 1995 to 2026

Other Outcomes (1)

  • Analysis of disease burden and health benefit assessment of severe/very severe deafness

    from 1995 to 2026

Study Arms (1)

Chinese cochlear implant patients from 1995 to 2026.

Other: Cochlear Implant

Interventions

Chinese cochlear implant patients from 1995 to 2026

Chinese cochlear implant patients from 1995 to 2026.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe/very severe sensorineural hearing loss.

You may qualify if:

  • Patients who received cochlear implants in Chinese medical institutions between 1995 and 2026;
  • Patients with preoperative diagnosis of severe/very severe sensorineural deafness;
  • Implantation age ≥ 6 months;
  • Records containing at least gender, date of birth, date of surgery, domicile, surgical area, type of implant surgery (first unilateral implant/first bilateral implant/first contralateral implant/re-implant) and implant model information.

You may not qualify if:

  • Lack of key information;
  • Other devices such as auditory brainstem implants (ABI) or middle ear implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman Dept of Otolaryngology Head and Neck Surgery Chinese PLA General Hospital

Study Record Dates

First Submitted

July 17, 2026

First Posted

September 15, 2026

Study Start

January 1, 1995

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

September 17, 2026

Record last verified: 2026-09