The aim of this clinical study is to investigate how the fitting of an EAS (electrical acoustic stimulation) based on electrocochleography (ECochG) thresholds compares to fitting based on pure tone audiogram thresholds in terms of speech intelligibility in quiet and noise. The personal feedback from the study participants regarding the question of better fitting and the resulting sound quality should also be included in the analysis.
Patients aged between 18-85 years.
Cochlear Implant (CI) candidates with measurable post-operative low-frequency residual hearing (125Hz <65dB, 250Hz <65dB, 500Hz <65dB).
Only patients with MED-EL EAS.
Written informed consent must be obtained prior to study start.
Patients with cognitive impairments who, as a result, lack the capacity to make decisions.
Uncooperative patients regarding pure tone audiometry thresholds measurements.
Morbus Menière or intracochlear/ vestibular schwannoma
Crossover
The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study.
Other interventionMeasured ECochG thresholds will be used in the initial EAS fitting in period 1 for sequence B. For sequence A, the ECochG-based EAS fitting (with up-to-date ECochG thresholds) will take place three months later at the beginning of period 2.
The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.
Other interventionThe control intervention is the subjective EAS fitting based on PTAs. This is provided to sequence A at the beginning of period 1 baseline and to sequence B at the beginning of period 2.
Speech Recognition Threshold (SRT50)
The primary outcome measure is the Speech Recognition Threshold (SRT50) at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design). The SRT50 measures speech understanding in noise and is defined as the Signal-to-Noise Ratio (measured in dB SNR) which yields 50% speech understanding, as determined by the OLSA test.
Subjective level of auditory benefit
A secondary outcome measure is subjective level of auditory benefit at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design), as determined using the HISQUI-19 (Hearing Implant Sound Quality Index) questionnaire.
Subjectively preferred EAS fitting method
The subjectively preferred EAS fitting method at the end of the study will be examined.
Post-operative ECochG and PTA tresholds
Post-operative ECochG and PTA thresholds at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design).
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Luzerner Kantonsspital
Lead sponsor
MED-EL Elektromedizinische Geräte GesmbH
Collaborator
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