Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
ConditionHearing Loss, Sensorineural
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorTodoc
About this trial
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sullivan
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Todoc
Lead sponsor
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov