Hearing Loss, SensorineuralNCT07018882
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
A study testing Sullivan in people with Hearing Loss, Sensorineural, run by Todoc.
Trial summary
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Sullivan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
Read the 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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Sullivan
- Keywords
- cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sullivan | Experimental | Not described Receives: Device: Sullivan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12-week and 24-week post-implant
Secondary outcomes (3)
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.
Measured: 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.
Measured: at the 12-week and 24-week post-implant
Change in pure-tone hearing thresholds
The average minimum pure-tone hearing thresholds before and after implant surgery (at 12 and 24 weeks) will be compared and observed.
The average minimum pure-tone hearing threshold is calculated as the mean of the minimum hearing thresholds at 500, 1000, 2000, and 3000 Hz.
Measured: at the 12-week and 24-week post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study startJun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Todoc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018882
- Sponsor's protocol ID
- Sullivan
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07018882
- Acronym / sponsor ID
- Sullivan
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- cochlear implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- TodocIndustry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sullivan | Experimental | Device: Sullivan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SullivanPatients 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. | Device | Sullivan |
Primary outcome
Change in open-set sentence recognition
Time frame: at 12-week and 24-week post-implant
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.
3 secondary outcomes
Change in open-set monosyllabic word recognition
Time frame: at the 12-week and 24-week post-implant
Change in open-set bisyllabic word recognition
Time frame: at the 12-week and 24-week post-implant
Change in pure-tone hearing thresholds
Time frame: at the 12-week and 24-week post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sullivan in people with Hearing Loss, Sensorineural, run by Todoc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in open-set sentence recognition (time frame: at 12-week and 24-week post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.