Severe to Profound Hearing LossROBOT-IC-BRUITNCT06248398
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
A study testing Surgery with RobOtol® and Conventional manual surgery in people with Severe to Profound Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe to Profound Hearing Loss
- What is being tested?
- Surgery with RobOtol® and Conventional manual surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2024to Dec 2025
- 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
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
Who cannot join
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
- Patients wearing electronic devices, in direct connection with the brain or nervous system
- Patient included in another interventional study (Jardé 1)
- Patient under legal protection (guardianship or curatorship) or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Ghizlene LAHLOU, Dr, 01 42 16 31 67, ghizlene.lahlou@aphp.fr
About this study
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year).
Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Read the detailed description
In the case of severe (70 to 90dB loss) and profound (>90dB loss) hearing loss, when conventional hearing aids no longer provide sufficient benefit, cochlear implantation remains the only possible solution for hearing rehabilitation. In implanted patients, a clear improvement in communication in silence is observed, but almost all patients have difficulty understanding speech in noisy environments. Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia. The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes.
The conventional method of this surgery is the manual insertion of the electrode holder. In recent years, robotic assistance, the RobOtol®, has been developed with the aim of avoiding the jerks of the surgeon's hand and improving the precision of the insertion. RobOtol® has had its CE marking since 2016 and is used in several hospitals in France and abroad.
- Conditions
- Severe to Profound Hearing Loss
- Being tested
- Surgery with RobOtol®, Conventional manual surgery
- Keywords
- Cochlear implant, Manual insertion, Robotic assistance insertion, Hearing understanding in noise, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with RobOtol®Procedure or surgery
Patient having cochlear implantation surgery with RobOtol®.
Conventional manual surgeryProcedure or surgery
Patient having conventional manual cochlear implantation surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patient having cochlear implantation surgery with RobOtol®. Receives: Procedure: Surgery with RobOtol® |
| Control arm | Other | Patient having conventional manual cochlear implantation surgery. Receives: Procedure: Conventional manual surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory performance in noise with the cochlear implant
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 6 months post-implantation
Measured: At 6 months post-implantation
Secondary outcomes (12)
Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Evolution of the intelligibility score (Variation of the percentage of words and phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation.
Measured: At 3 and 6 months post-implantation
Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for Fr-Bio words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation. The noise will be an ecological noise (restaurant or street noise) using the Immersion® system.
Measured: At 3 and 6 months post-implantation
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
Measured: At 3 and 6 months post-implantation
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Evolution of the intelligibility score (Variation of the percentage of phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
Measured: At 3 and 6 months post-implantation
The subjective benefit on tinnitus after robotic cochlear implantation compared to conventional manual cochlear implantation
Evolution of the Patient's Related Outcomes Measures using questionnaire concerning the tinnitus with the Tinnitus Handicap Inventory (THI)
Measured: At 3 and 6 months post-implantation
The subjective benefit on quality of life after robotic cochlear implantation compared to conventional manual cochlear implantation
Evolution of the Patient's Related Outcomes Measures using the questionnaire concerning the quality of life with the Cochlear Implant Quality of Life (CIQOL)
Measured: At 3 and 6 months post-implantation
The position of the electrode array in the cochlea during manual and robotic insertions
the position of each electrode will be analyzed blindly on the post-operative CT-scan.
Measured: At day one post -implantation
The impact of a translocation on auditory performance in silence and in noise
Auditory scores measured at 3 and 6 months after implantation will be correlated to the presence of a translocation of the electrode array assessed on the post-operative CT scan.
Measured: At 3 and 6 months post-implantation
The effort of listening in silence and in noise after manual and robotic insertions assessed with the Speech, Spatial and Qualities of Hearing Scale (SSQ)
The effort of listening will be analyzed with SSQ scale
Measured: At 3 and 6 months post-implantation
The effort of listening in silence and in noise after manual and robotic insertions assessed with a visual analog scale
The effort of listening will be analyzed after each audiologic test with a visual analog scale, using which the patient will rate from 0 to 10 the effort made to understand the words presented (Bräcker et al., 2019)
Measured: At 3 and 6 months post-implantation
The preservation of residual hearing after cochlear implantation in cases with residual hearing before surgery
Evolution of auditory thresholds measured with tonal audiometry between preoperative and postoperative measurements on the operated ear.
Measured: At 30 days, 3 months and 6 months post-implantation
The presence of postoperative vertigo in case of robotic cochlear implantation compared to manual implantation
Evaluation of vertigo with the Dizziness Handicap Inventory (DHI) questionnaire
Measured: At 7 days, 3 months and 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start20 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe to Profound Hearing LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghizlene LAHLOU, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248398
- Sponsor's protocol ID
- APHP211330
- Other IDs
- 2023-A00837-38
- Acronym
- ROBOT-IC-BRUIT
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
- ClinicalTrials.gov ID
- NCT06248398
- Acronym / sponsor ID
- ROBOT-IC-BRUIT / APHP211330
- Conditions
- Severe to Profound Hearing Loss
- Keywords
- Cochlear implant, Manual insertion, Robotic assistance insertion, Hearing understanding in noise, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Feb 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.
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year).
Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Detailed description
In the case of severe (70 to 90dB loss) and profound (>90dB loss) hearing loss, when conventional hearing aids no longer provide sufficient benefit, cochlear implantation remains the only possible solution for hearing rehabilitation. In implanted patients, a clear improvement in communication in silence is observed, but almost all patients have difficulty understanding speech in noisy environments. Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia. The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes.
The conventional method of this surgery is the manual insertion of the electrode holder. In recent years, robotic assistance, the RobOtol®, has been developed with the aim of avoiding the jerks of the surgeon's hand and improving the precision of the insertion. RobOtol® has had its CE marking since 2016 and is used in several hospitals in France and abroad.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Surgery with RobOtol®Patient having cochlear implantation surgery with RobOtol®. |
| Control arm | Other | Procedure: Conventional manual surgeryPatient having conventional manual cochlear implantation surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
Key exclusion criteria (8 listed)
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
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 |
|---|---|---|
| Surgery with RobOtol®Patient having cochlear implantation surgery with RobOtol®. | Procedure or surgery | Experimental arm |
| Conventional manual surgeryPatient having conventional manual cochlear implantation surgery | Procedure or surgery | Control arm |
Primary outcome
Auditory performance in noise with the cochlear implant
Time frame: At 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 6 months post-implantation
12 secondary outcomes
Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Time frame: At 3 and 6 months post-implantation
Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words
Time frame: At 3 and 6 months post-implantation
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Time frame: At 3 and 6 months post-implantation
The subjective benefit on tinnitus after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
The subjective benefit on quality of life after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
The position of the electrode array in the cochlea during manual and robotic insertions
Time frame: At day one post -implantation
The impact of a translocation on auditory performance in silence and in noise
Time frame: At 3 and 6 months post-implantation
The effort of listening in silence and in noise after manual and robotic insertions assessed with the Speech, Spatial and Qualities of Hearing Scale (SSQ)
Time frame: At 3 and 6 months post-implantation
The effort of listening in silence and in noise after manual and robotic insertions assessed with a visual analog scale
Time frame: At 3 and 6 months post-implantation
The preservation of residual hearing after cochlear implantation in cases with residual hearing before surgery
Time frame: At 30 days, 3 months and 6 months post-implantation
The presence of postoperative vertigo in case of robotic cochlear implantation compared to manual implantation
Time frame: At 7 days, 3 months and 6 months post-implantation
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 17 Feb 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Ghizlene LAHLOU, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with RobOtol® and Conventional manual surgery in people with Severe to Profound Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 8 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 17 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 France. 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 Ghizlene LAHLOU, Dr (01 42 16 26 10, ghizlene.lahlou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory performance in noise with the cochlear implant (time frame: At 6 months post-implantation). 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 17 Feb 2025.