Cochlear ImplantsBULLS-INCT06453343
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
A study testing Surgical approach: cochleostomy or extended round window in people with Cochlear Implants and Hearing Loss, Sensorineural, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants, Hearing Loss, Sensorineural
- What is being tested?
- Surgical approach: cochleostomy or extended round window
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to Nov 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
- CI candidate based on local or national reimbursement criteria.
- Cochlear implantation with a CI632.
- Preoperative 500 Hz pure-tone air conduction threshold <80 dB hearing level (HL) in the ear to be implanted.
- Willing and able to provide written informed consent.
Who cannot join
- Previous or existing CI recipient.
- Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
- Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- Subjects who are unable to undergo CT or MRI.
- Deafness due to acoustic nerve or central auditory pathway lesions.
- Diagnosis of auditory neuropathy.
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- Active middle ear infection.
- Additional handicaps that would prevent participation in study evaluations.
- Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emmanuel Mylanus contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen
Lindeboom, Coby.lindeboom@radboudumc.nl
About this study
Official title: Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.
Read the detailed description
Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead.
Objective: The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging.
Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of <80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.
- Conditions
- Cochlear Implants, Hearing Loss, Sensorineural
- Being tested
- Surgical approach: cochleostomy or extended round window
- Keywords
- Surgical approach, Round Window, Cochleostomy, Electrocochleography, Imaging, Residual hearing preservation
- 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.
Surgical approach: cochleostomy or extended round windowProcedure or surgery
Surgical placement of a cochlear implant electrode array
| Study group | Role | What they receive |
|---|---|---|
| Cochleostomy | Active comparator | When employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane. Receives: Procedure: Surgical approach: cochleostomy or extended round window |
| extended Round Window | Active comparator | In case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy. Receives: Procedure: Surgical approach: cochleostomy or extended round window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual hearing
The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow).
Measured: 3-months postoperatively
Secondary outcomes (2)
ECochG thresholds after multiple surgery stages
ECochG thresholds with a promontory recording electrode after the following surgery stages: a) posterior tympanotomy (baseline), b) drilling for RW membrane exposure, c) completion of the approach to implantation (CO or eRW), d) sheath insertion, e) electrode array insertion, f) sheath withdrawal, and g) positioning of the electrode lead.
Measured: Intraoperatively
Intracochlear electrode position
The position of electrode contacts relative to the modiolus and the angular insertion depth (AID), as assessed with pre- and post-operative CT-scan.
Measured: 3-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453343
- Sponsor's protocol ID
- NL85808.091.23
- Acronym
- BULLS-I
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing
- ClinicalTrials.gov ID
- NCT06453343
- Acronym / sponsor ID
- BULLS-I / NL85808.091.23
- Conditions
- Cochlear Implants, Hearing Loss, Sensorineural
- Keywords
- Surgical approach, Round Window, Cochleostomy, Electrocochleography, Imaging, Residual hearing preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus, Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Jun 2024 (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.
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.
Detailed description
Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead.
Objective: The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging.
Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of <80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochleostomy | Active comparator | Procedure: Surgical approach: cochleostomy or extended round windowWhen employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane. |
| extended Round Window | Active comparator | Procedure: Surgical approach: cochleostomy or extended round windowIn case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
- CI candidate based on local or national reimbursement criteria.
- Cochlear implantation with a CI632.
- Preoperative 500 Hz pure-tone air conduction threshold <80 dB hearing level (HL) in the ear to be implanted.
- Willing and able to provide written informed consent.
Key exclusion criteria (10 listed)
- Previous or existing CI recipient.
- Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
- Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- Subjects who are unable to undergo CT or MRI.
- Deafness due to acoustic nerve or central auditory pathway lesions.
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 |
|---|---|---|
| Surgical approach: cochleostomy or extended round windowSurgical placement of a cochlear implant electrode array | Procedure or surgery | Cochleostomy, extended Round Window |
Primary outcome
Residual hearing
Time frame: 3-months postoperatively
The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow).
2 secondary outcomes
ECochG thresholds after multiple surgery stages
Time frame: Intraoperatively
Intracochlear electrode position
Time frame: 3-months postoperatively
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 25 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Emmanuel Mylanus contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical approach: cochleostomy or extended round window in people with Cochlear Implants and Hearing Loss, Sensorineural, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Coby Lindeboom, MD (024 361 14934, Coby.lindeboom@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual hearing (time frame: 3-months postoperatively). 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 25 Feb 2025.