Cochlear Hearing Loss Clinical Trial
— ICRobManOfficial title:
Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position
Verified date | October 2023 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 44 Years to 73 Years |
Eligibility | Inclusion Criteria: - bilateral cochlear implantation at a tertiary referral center - one side manual - one side robot-assisted Exclusion Criteria: - opposition - under curatorship |
Country | Name | City | State |
---|---|---|---|
France | Chru de Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Speech disyllabic recognition | at 1 year | ||
Secondary | Pure tone average | At 1 year | ||
Secondary | Intrascalar positionning | Postoperatively |
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