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

Todoc

Status

Not yet enrolling

Conditions

Hearing Loss, Sensorineural

Treatments

Device: Sullivan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07018882

Sullivan

Details and patient eligibility

About

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

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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