Is an intraoperative Pre-Insertion Telemetry of a cochlear implant before insertion necessary?

Background

The Cochlear Implant (CI) surgery is an interdisciplinary process involving medical and technical personnel. High quality standards are intended to ensure patient safety and guarantee that the implant functions correctly. A so-called “pre‑insertion telemetry” can be performed to improve quality standards. The presented study is intended to determine whether implant defects are reliably detected by this measurement.

Methods

The retrospective study investigated the intraoperative pre-insertion telemetry on CIs at the university ENT clinic Frankfurt (Main) from 2010 to 2021 regarding irregularities and tested feasibility, validity and temporal effort. The pre-insertion telemetry verifies a bidirectional data transfer between the implant and the measurement system, by recording the electrical impedances of each electrode. In the case of an irregular pre-insertion telemetry with a suspected device failure, a backup implant was used. The rejected implant underwent an investigation by the manufacturer.

Results

During the study period, 15 of 1,926 CIs had an irregular pre-insertion telemetry and a suspected device failure. All 15 implants were rejected and replaced with backup implants. All rejected implants showed functional bidirectional data transfer, but with irregular electrical impedances at one or more electrodes. In 13 cases, the suspected technical device failure was confirmed by the subsequent inspections of the manufacturers.

Discussion

With the pre-insertion telemetry, device failures of CIs could be reliably detected. The pre-insertion telemetry is a fast and safe procedure that increases quality control. Performing a pre-insertion telemetry of a CI is recommended and it should be considered as additional quality check.

Publication History

Article published online:
24 May 2022