Evaluation of SON’OR©, a Medical Device for Provoked Otoacoustic Emissions and Brainstem Evoked Response Audiometry Made in Cameroon

Abstract

Background: There is a huge gap in the audiological care in Africa by comparison with Western countries. Its main reason is the prohibitive cost of the medical devices used to screen or diagnose patients. A Cameroonian team tackled this problem by developing a medical device (SON’OR^©) which integrates a new instrumentation amplifier structure dedicated to perform otoacoustic emissions (OAE) and brainstem evoked response audiometry (BERA). The major technical challenges to perform OAE and BERA are the synchronization and the amplification of signals of very low amplitude. In this work, we emphasize on the general criteria necessary and indispensable to achieve an optimal amplification. The application of a novel instrumentation amplifier structure characterized by its optimized noise factor in the case of BERA and OEA emissions provides simulations and experimental results fully in line with forecasts. The design of SON’OR^© is based on general techniques of electronic instrumentation to which we associated the new instrumentation amplifier structure. Objective: To report the clinical evaluation of SON’OR^© as a screening and diagnostic tool. Methods: We conducted a cross sectional comparative study in Centre Hospitalier d’Essos in Yaoundé. We tested SON’OR^© on two sets of subjects, one for OAE with OTODYNAMICS Echoport ILO 292-II as gold standard and the other for BERA with NEUROSOFT NEURO AUDIO^© as gold standard. Each patient was tested with both devices and then we studied the inter device differences and calculated the sensitivity, specificity, positive predictive value and negative predictive value for each test. Results: We got 52 subjects for OEA and 51 for BERA testing. Sex ratio was 1 woman for 2 men in both groups. Mean age was 24.86(SD = 10.53) and 26.33 (10.55) for OAE and BERA groups respectively. SON’OR^© had good performances, showing sensitivity of 92.85%/95%, specificity of 96.77%/90.47%, positive predictive value of 95.21%/93.44% and negative predictive value of 95.23%/92.68% for OAE/ BERA respectively. Conclusion: SON’OR^© has good characteristics as a medical diagnostic tool. Furthermore its stability and performances in poor electrical conditions make it a robust device really suited for resource limited settings.