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

NCT07018882 | Not Yet Recruiting

• 1 other identifier: Sullivan
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hearing Loss, Sensorineural

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (1)

• 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.

  at 12-week and 24-week post-implant

Secondary Outcomes (3)

• Change in open-set monosyllabic word recognition

  at the 12-week and 24-week post-implant

• Change in open-set bisyllabic word recognition

  at the 12-week and 24-week post-implant

• Change in pure-tone hearing thresholds

  at the 12-week and 24-week post implant

Study Arms (1)

Sullivan

EXPERIMENTAL

Device: Sullivan

Interventions

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.

Sullivan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Todoc: lead
• Samsung Medical Center: collaborator

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06