Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07018882

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sullivan

Device

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 outcomes

  1. Change in open-set sentence recognition

    Time frame: at 12-week and 24-week post-implant

    Sentences will be presented before the implant surgery, and at 12- and 24-weeks post implant, to assess and record the patient's sentence recognition ability. A total of 10 sentences, comprising 50 words, will be used for this evaluation.

    For each sentence, the percentage of correctly recognized words will be calculated out of the total 50 words across the 10 sentences. Sentence recognition abilities for each participant will be assessed at pre-surgery, 12 weeks, and 24 weeks. Improvement in sentence recognition at 12 weeks and 24 weeks will be determined by comparing these post-implant scores with pre-surgery scores.

Secondary outcomes

  1. Change in open-set monosyllabic word recognition

    Time frame: at the 12-week and 24-week post-implant

    Pre- and post-implant (at 12 and 24 weeks) monosyllabic word recognition will be assessed by presenting words auditorily, with results recorded, compared, and observed. The assessment will use 20 monosyllabic words.

    For each participant, pre-surgery, 12-week, and 24-week monosyllabic word recognition scores will be calculated as the percentage of correctly recognized words out of the total 20 words.

    The difference in monosyllabic word recognition between pre-surgery and 12 weeks post-surgery, as well as between pre-surgery and 24 weeks post-surgery, will be calculated.

  2. Change in open-set bisyllabic word recognition

    Time frame: at the 12-week and 24-week post-implant

    Pre- and post-implant (at 12 and 24 weeks) bisyllabic word recognition will be assessed by presenting words auditorily, with results recorded, compared, and observed. The cognitive assessment will use 20 bisyllabic words.

    For each participant, pre-surgery, 12-week, and 24-week bisyllabic word recognition scores will be calculated as the percentage of correctly recognized words out of the total 20 words.

    The difference in bisyllabic word recognition between pre-surgery and 12 weeks post-surgery, as well as between pre-surgery and 24 weeks post-surgery, will be calculated.

  3. Change in pure-tone hearing thresholds

    Time frame: at the 12-week and 24-week post implant

    The average minimum pure-tone hearing thresholds before and after implant surgery (at 12 and 24 weeks) will be compared and observed.

    The average minimum pure-tone hearing threshold is calculated as the mean of the minimum hearing thresholds at 500, 1000, 2000, and 3000 Hz.

Sponsors and collaborators

Lead sponsor

Todoc

Industry

Collaborators

  • Samsung Medical Center

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.