Clinical trial NCT07018882: Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: cochlear implant
Lead sponsor: Todoc
Sponsor class: INDUSTRY
Collaborators: name: Samsung Medical Center
First posted: 2025-06-13
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in open-set sentence recognition
timeFrame: at 12-week and 24-week post-implant
Secondary outcomes:
measure: Change in open-set monosyllabic word recognition
timeFrame: at the 12-week and 24-week post-implant
measure: Change in open-set bisyllabic word recognition
timeFrame: at the 12-week and 24-week post-implant
measure: Change in pure-tone hearing thresholds
timeFrame: at the 12-week and 24-week post implant
Other outcomes:
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