Robotic middle ear access for cochlear implantation: First in man

PLoS One. 2019 Aug 2;14(8):e0220543. doi: 10.1371/journal.pone.0220543. eCollection 2019.

Abstract

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cochlea / surgery*
  • Cochlear Implantation / methods*
  • Cochlear Implants*
  • Feasibility Studies
  • Female
  • Hearing Loss / surgery*
  • Humans
  • Male
  • Middle Aged
  • Robotic Surgical Procedures / methods*
  • Treatment Outcome

Grants and funding

Work leading to this clinical study was supported by the Swiss National Science Foundation (project NCCR Co-Me), the Swiss Commission for Technology and Innovation (project MIRACI 17618.1), the European Commission (project HEAR-EU, 304857), the Swiss Nano-Tera initiative (project HearRestore), MED-EL GmbH (Innsbruck, Austria), CAScination AG (Bern, Switzerland), and Xoran Technologies (Ann Arbor, USA). The study itself was solely funded by institutional support of the University of Bern and the Inselspital University hospital Bern. Support by commercial partners was provided in the form of research material and in-kind contributions. None of the commercial funders had any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.