Use of Research Interfaces for Psychophysical Studies With Cochlear-Implant Users.

A growing number of laboratories are using research interfaces to conduct experiments with cochlear-implant (CI) users. Because these interfaces bypass a subject's clinical sound processor, several concerns exist regarding safety and stimulation levels. Here we suggest best-practice approaches for how to safely and ethically perform this type of research and highlight areas of limited knowledge where further research is needed to help clarify safety limits. The article is designed to provide an introductory level of technical detail about the devices and the effects of electrical stimulation on perception and neurophysiology. From this, we summarize what should be the best practices in the field, based on the literature and our experience. Findings from the review of the literature suggest that there are three main safety concerns: (a) to prevent biological or neural damage, (b) to avoid presentation of uncomfortably loud sounds, and (c) to ensure that subjects have control over stimulus presentation. Researchers must pay close attention to the software-hardware interface to ensure that the three main safety concerns are closely monitored. An important area for future research will be the determination of the amount of biological damage that can occur from electrical stimulation from a CI placed in the cochlea, not in direct contact with neural tissue. As technology used in research with CIs evolve, some of these approaches may change. However, the three main safety principles outlined here are not anticipated to undergo change with technological advances.