A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion.
Otol Neurotol
; 44(1): 34-39, 2023 01 01.
Article
en En
| MEDLINE
| ID: mdl-36509435
ABSTRACT
OBJECTIVE:
To evaluate the safety and utility of an investigational robotic-assisted cochlear implant insertion system. STUDYDESIGN:
Prospective, single-arm, open-label study under abbreviated Investigational Device Exemption requirements.SETTING:
All procedures were performed, and all data were collected, at a single tertiary referral center. PATIENTS Twenty-one postlingually deafened adult subjects that met Food and Drug Administration indication criteria for cochlear implantation. INTERVENTION All patients underwent standard-of-care surgery for unilateral cochlear implantation with the addition of a single-use robotic-assisted insertion device during cochlear electrode insertion. MAIN OUTCOMEMEASURES:
Successful insertion of cochlear implant electrode array, electrode array insertion time, postoperative implant function.RESULTS:
Successful robotic-assisted insertion of lateral wall cochlear implant electrode arrays was achieved in 20 (95.2%) of 21 patients. One insertion was unable to be achieved by either robotic-assisted or manual insertion methods, and the patient was retrospectively found to have a preexisting cochlear fracture. Mean intracochlear electrode array insertion time was 3 minutes 15 seconds. All implants with successful robotic-assisted electrode array insertion (n = 20) had normal impedance and neural response telemetry measures for up to 6 months after surgery.CONCLUSIONS:
Here we report the first human trial of a single-use robotic-assisted surgical device for cochlear implant electrode array insertion. This device successfully and safely inserted lateral wall cochlear implant electrode arrays from the three device manufacturers with devices approved but he Food and Drug Administration.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Implantes Cocleares
/
Implantación Coclear
Tipo de estudio:
Observational_studies
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
Otol Neurotol
Asunto de la revista:
NEUROLOGIA
/
OTORRINOLARINGOLOGIA
Año:
2023
Tipo del documento:
Article