Cochlear Implant Fitting via Objective Neural Response Mapping
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Solution Overview
Problem
Current cochlear implant fitting methods are time-consuming and require extensive clinical experience, often relying on subjective patient feedback, and can lead to overstimulation, especially when measuring Maximum Comfortable Loudness (MCL) thresholds, which are challenging to determine accurately, especially in awake patients.
Innovation Solution
A cochlear implant system that uses a test stimulation generator to deliver variable charge and stimulation rate sequences inversely related to a defined loudness percept, allowing for objective response measurements to define a patient-specific fit map, reducing the risk of overstimulation and shortening the fitting process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional subjective fitting methods are used to determine MCL thresholds, then clinical experience and patient feedback can guide fitting, but the process becomes time-consuming and may lead to overstimulation
Solution Approach 1:
The patent replaces subjective patient feedback and clinician judgment with objective electrophysiological measurements (ECAPs and eSRTs). Electrical stimulation is used to elicit measurable neural responses, substituting the mechanical/subjective assessment process with an electrical-biological measurement system that provides quantifiable data for threshold determination.
Solution Approach 2:
The patent implements feedback loops where objective measurements (ECAP amplitudes, eSRT thresholds) are continuously monitored and used to adjust stimulation parameters. The system measures neural responses and uses this feedback to automatically determine MCL and THR thresholds, eliminating the need for time-consuming subjective assessment while improving measurement accuracy.
2Measurement precision
If extensive clinical experience is relied upon for fitting, then subjective judgment can guide parameter selection, but the process requires highly trained personnel and extends fitting time
Solution Approach 1:
The patent enables the cochlear implant system to perform self-adjustment of fitting parameters through automated objective measurements. The system independently determines MCL and THR thresholds using ECAP and eSRT measurements without requiring extensive clinician intervention or subjective judgment, making the fitting process more autonomous and less dependent on specialized expertise.
Solution Approach 2:
The patent changes the fundamental parameters used for fitting from subjective patient-reported outcomes to objective electrophysiological parameters (ECAP amplitudes, eSRT thresholds). This parameter transformation allows automated determination of stimulation levels, reducing reliance on clinician experience while improving consistency and accuracy of fitting parameters.
3Reliability
If MCL thresholds are measured using conventional methods, then patient comfort can be assessed, but the risk of overstimulation increases and measurements become unreliable in awake patients
Solution Approach 1:
The patent introduces intermediate electrophysiological measurements (ECAPs and eSRTs) as mediators between the stimulation electrode and the patient's perceptual response. These intermediate biological signals serve as reliable proxies for MCL thresholds, allowing indirect but more reliable measurement that avoids the unreliability of direct patient feedback while preventing overstimulation through objective monitoring.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enables a faster and more accurate creation of patient-specific fit maps without exceeding MCL thresholds, reducing the risk of overstimulation and improving the efficiency of the fitting process, even in awake patients.
Implementation Method 1
obtain objective response measurements of auditory neural tissues of the implanted patient that are affected by the test stimulation sequence
Data Source
AI summary
A fitting system is described for fitting electrode contacts of cochlear implant electrode array implanted in a cochlea of an implanted patient. A test stimulation generator delivers to at least one of the electrode contacts a test stimulation sequence at a variable charge level and a variable stimulation rate over time, wherein the charge level and stimulation rate are inversely related as a function of a defined loudness percept by the implanted patient to the test stimulation sequence. A response measurement module obtains objective response measurements of auditory neural tissues of the implanted patient that are affected by the test stimulation sequence. A fit mapping module defines a patient-specific fit map for the electrode contacts of cochlear implant electrode array based on the objective response measurements.