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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06235073
Acronym
ICRobMan
Enrollment
10
Registered
2024-01-31
Start date
2023-07-01
Completion date
2023-09-30
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
44 Years to 73 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* opposition * under curatorship

Design outcomes

Primary

MeasureTime frame
Speech disyllabic recognitionat 1 year

Secondary

MeasureTime frame
Pure tone averageAt 1 year
Intrascalar positionningPostoperatively

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026