Comparing robotic and manual cochlear implantation for hearing in noise

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of robotic-assisted cochlear implantation versus conventional manual insertion in patients with severe to profound hearing loss. A total of 140 patients will be randomized into two groups, with 70 receiving robot-assisted surgery and 70 undergoing manual surgery. Participants will be evaluated preoperatively and at 3 and 6 months post-activation of the cochlear implant, focusing on hearing performance in noisy environments and overall quality of life. The study will take place at the Pitié-Salpêtrière hospital in Paris over a period of 17 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Groupe Hospitalier Pitié-Salpêtrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Ghizlene LAHLOU, Dr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Ghizlene LAHLOU, Dr
• Email: ghizlene.lahlou@aphp.fr
• Phone: 01 42 16 26 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.