Risk of Monopolar Electrosurgery in Cochlear Implant Recipients is Nominal: Evidence to Guide Clinical Practice

Area of Science:

• Otolaryngology
• Neurosurgery
• Medical Device Safety

Background:

• Cochlear implants (CIs) are sophisticated neuroprosthetic devices.
• Electrosurgery is commonly used in head and neck procedures.
• Potential risks of electrosurgery to CI devices require assessment.

Purpose of the Study:

• To determine the prevalence of device complications from monopolar electrosurgery in cochlear implant recipients.
• To evaluate the safety of using monopolar electrosurgery in CI patients.

Main Methods:

• A multifaceted review including literature search, institutional data, manufacturer data, and surveys of high-volume centers.
• Analysis of device-cautery exposures reported in human studies and institutional records.
• Review of industry data from 3 FDA-approved CI manufacturers and surveys of 8 high-volume CI centers.

Main Results:

• Literature review identified 199 device-cautery exposures with no reported CI damage in patient records.
• Institutional data showed no CI damage in 84 instances of exposure.
• Manufacturer data revealed only one potential damage event out of 689,426 CIs; surveys found no adverse events.

Conclusions:

• The risk of adverse events or tissue injury from monopolar electrosurgery in CI recipients is extraordinarily low.
• Monopolar electrosurgery can be safely used in the head and neck of CI recipients, provided it's not in immediate proximity to the implant.
• Findings support the use of monopolar electrosurgery in CI patients and aid in patient counseling.