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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Cochlear Hearing Loss

Study type

Observational

Funder types

Other

Identifiers

NCT06235073
29BRC23.0107 - ICRobMan

Details and patient eligibility

About

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.

Full description

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. The 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.

Enrollment

10 patients

Sex

All

Ages

44 to 73 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • bilateral cochlear implantation at a tertiary referral center
  • one side manual
  • one side robot-assisted

Exclusion criteria

  • opposition
  • under curatorship

Trial design

10 participants in 2 patient groups

Manual implantation
Robot assisted implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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