Abstract
For more than a decade, Neural Response Telemetry (NRT) has provided direct access to the electrically evoked compound action potential (ECAP) as elicited by the Nucleus cochlear implant. When used clinically during fitting, ECAP threshold profiles are applied by shifting the profile to the audible threshold and comfort level boundaries (the T- and C-level profiles, respectively). The resulting profiles, to date, have matched the curvature of the ECAP threshold profile exactly. When compared with psychophysical profiles, previous studies have shown that this approach incurs errors in program levels that are no better than flat or population mean profiles. However, C-level profiles are observed to be flatter than T-level profiles. Accordingly, ECAP threshold profiles are flattened in this study when applied at increasing stimulus levels, and the effectiveness of this approach is evaluated among other methods. In phase I, ECAP thresholds (via AutoNRT) and T- and C-levels were measured from 15 adult Nucleus Freedom implantees. Psychophysical levels were measured using pulse train stimuli at six different stimulation rates, spanning 80 to 3500 Hz. The different rates spread T- and C-levels across a range of stimulus levels. At each of these levels, a scaling factor of best fit was calculated such that the shifted ECAP threshold profile, when scaled (0 giving a flat profile, 1 giving an unmodified profile), gave the best fit to the corresponding psychophysical profile. From the 148 such T- and C-level profiles, a single profile scaling model was determined by a simple linear regression. In phase II, the model was tested on data using three separate stimulation rates (250, 900, and 2400 Hz) and 14 additional subjects. The root mean square psychophysical level mismatch of the ECAP threshold profile, the scaled ECAP threshold profile, a flat profile, and a mean population profile was calculated per subject and per stimulation rate, and the differences in the means of these calculations were compared. In phase III, 13 separate subjects evaluated the scaled ECAP-based program during a 2 wk trial, comparing the new program to a flat program and a conventional ECAP-based program with unmodified ECAP threshold profiles. A questionnaire captured their subjective preferences. In phase I, the profile scaling model constructed from the data prescribed a flattening of the ECAP threshold profile with increasing mean T- or C-level (in CL units): scale = 1.38 - 0.0043 PsychoMean. In phase II, the scaled ECAP-based profiles were found to fit the psychophysical profiles significantly better in all test configurations (typically of the order of 5% dynamic range) compared with all other profiles. In phase III, 62% of subjects preferred the scaled ECAP-based program, whereas 8% preferred the conventional ECAP-based program, 15% the flat program and 15% had no preference. Analyses of the questionnaires revealed significantly higher ratings for the scaled ECAP-based programs, whereas the conventional ECAP-based programs were not rated differently than the flat programs. The scaled ECAP threshold profile method provides a clinically significant enhancement to ECAP-based fitting methods, confirming the value of the ECAP threshold profile to cochlear implant fitting.
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