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Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)

NCT06235073 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-01-31

No results posted yet for this study

Summary

Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. WThe investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.

This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

Conditions

  • Cochlear Hearing Loss

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Eligibility

Min Age
44 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235073 on ClinicalTrials.gov