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

N/ANot Yet RecruitingNCT07018882

Todoc25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

SullivanDEVICE

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

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in open-set sentence recognition

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.

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

Secondary Outcomes

Change in open-set monosyllabic word recognition

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.

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

Change in open-set bisyllabic word recognition

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.

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

Data from ClinicalTrials.gov

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