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Not yet recruiting NCT07018882

Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.

No phase Interventional Hearing Loss, Sensorineural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sullivan.
Who it may be relevant to
Registry conditions: Hearing Loss, Sensorineural. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Single-Center, Single-arm, Open, Prospective, Pivotal Clinical Trial for Evaluating the Audiological Efficacy and Safety of Sullivan Cochlear Implantation in Patients With Severe to Profound Bilateral Hearing Loss.

Overview

The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study

Detailed description

This study is a clinical trial designed to examine the auditory performance improvement in patients with bilateral severe sensorineural hearing loss (70 dB HL or greater) by comparing auditory performance before and after cochlear implant surgery.

Cochlear implants, both imported and domestically manufactured, have already been approved and are in use in the country. These existing devices have also undergone clinical research, comparing and analyzing auditory performance before and after implantation. Therefore, this study is designed as a prospective, single-arm, open-label clinical trial.

Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments.

Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Interventions

  • Device Sullivan
    Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments. Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Primary outcome measures

  • Change in open-set sentence recognition [Time frame: at 12-week and 24-week post-implant]
Secondary outcome measures (3)
  • Change in open-set monosyllabic word recognition [Time frame: at the 12-week and 24-week post-implant]
  • Change in open-set bisyllabic word recognition [Time frame: at the 12-week and 24-week post-implant]
  • Change in pure-tone hearing thresholds [Time frame: at the 12-week and 24-week post implant]

Eligibility criteria

Inclusion criteria

  • Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older
  • No previous cochlear implantation history in the ear scheduled for surgery
  • No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests
  • Patients without cancer, autoimmune disease, or neurological disease
  • Patients with a general condition that allows general anesthesia
  • Patients with no abnormalities in personality, depression, anxiety, sociality, or problem drinking tests
  • Use Korean
  • Patients who agree to participate in the clinical trial and sign a written consent form However, if the patient is unable to sign, the patient (if able to sign) and guardian (or agent) voluntarily agree to participate in the clinical trial and sign an informed consent form

Exclusion criteria

  • Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.
  • Cases with cancer or autoimmune disease
  • Cases with a general condition that makes it difficult to tolerate general anesthesia
  • Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education
  • Cases deemed inappropriate for this test by the clinical trial manager

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07018882 · Sullivan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗