Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study.

PURPOSE: Evaluating the effectiveness of intraoperative auditory brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant for quantifying the implant's floating mass transducer (FMT) coupling quality. METHODS: In a diagnostic multicentric study, patients (> 18 years) who received a VSB with different coupling modalities were included. Pre- and postoperative bone conduction thresholds, intraoperative VSB-evoked ABR thresholds (VSB-ABR) using a modified audio processor programmed to preoperative bone conduction thresholds, postoperative vibrogram thresholds, and postoperative VSB-ABR thresholds were measured. Coupling quality was calculated from the difference between the pure tone average at 1000, 2000, and 4000 Hz (3PTA) vibrogram and postoperative 3PTA bone conduction thresholds. RESULTS: Twenty-three patients (13 males, 10 females, mean age 56.6 (± 12.5) years) were included in the study. Intraoperative VSB-ABR response thresholds could be obtained in all except one patient where the threshold was > 30 dB nHL. Postoperatively, an insufficient coupling of 36.7 dB was confirmed in this patient. In a Bland-Altman analysis of the intraoperative VSB-ABRs and coupling quality, the limits of agreement exceeded ± 10 dB, i.e., the maximum allowed difference considered as not clinically important but the variation was within the general precision of auditory brainstem responses to predict behavioral thresholds. Five outliers were identified. In two patients, the postoperative VSB-ABR thresholds were in agreement with the coupling quality, indicating a change of coupling before the postoperative testing. CONCLUSION: The response thresholds recorded in this set-up have the potential to predict the VSB coupling quality and optimize postoperative audiological results.

Slope of electrically evoked compound action potential amplitude growth function is site-dependent.

OBJECTIVES: In human cochlear implant (CI) recipients, the slope of the electrically evoked compound action potential (ECAP) amplitude growth function (AGF) is not very well investigated, in comparison to the threshold derived from the AGF. This is despite the fact that it was shown in animal experiments that the slope correlates with the number of excitable neurons. The rationale of this study was to establish baseline data of the AGF slope for possible clinical applications, while investigating stability over time and dependence on cochlear site. DESIGN: ECAP AGFs of 16 ears implanted with MED-EL CIs were recorded on all electrode contacts during the normal clinical routine at 4 different points in time. RESULTS: Due to patient availability, not all 16 ears could be measured at all 4 points in time. A dependence of the slope on the electrode position was visible and statistically significant: At the three electrode contacts at the apical end of the array, the slope is greater compared to the medial and basal region of the cochlea. CONCLUSION: The three most apical electrode contacts show greater slopes of ECAP AGF recordings. Our data of the cohort slopes show mild effects between the 4 different points in time.

Intraoperatives Tip-Foldover-Screening mittels Spread of Excitation Messungen.

BACKGROUND: In rare cases, a cochlear implantation can lead to a so-called tip fold-over during insertion of the electrode array. In order to detect or exclude such a misalignment a radiological check of the cochlear implant (CI) electrode array is carried out intra- or often post-operatively (gold standard), thereby exposing the patient to additional radiation. Alternatively, successful electrode insertion can be verified by measuring the spread of excitation (SOE). However, interpretation of the test results requires considerable expertise, and standardized measurement protocols and reference values are also essential. Therefore, the aim of the study is to evaluate an automated screening procedure in order to obtain a reliable statement about the normal tonotopic position of the implanted CI electrode array intraoperatively and with as little effort as possible. METHODS: For CI surgery with Cochlear™ Nucleus® implants, an intraoperative tip-fold-over (TFO) screening was performed in a bi-centric study in over 100 adult patients: Firstly, threshold measurements for electrically evoked compound action potential (ECAP) using AutoNRT™ were recorded. Subsequently, SOE measurements were carried out on electrodes 13 and 22. The automated evaluation of the SOE data sets then made it possible to make a dichotomous decision about a normal or abnormal test result. The position of the electrode array was checked intra- or post-operatively using conventional transorbital X-ray (reference method). RESULTS: The intraoperative TFO screening procedure is applicable in around 80% of cases. The accuracy of the screening for measurements via the active stimulation electrodes 13 / 22 is 63.9% / 95.4%. The classification error is 36.1% / 4.6% and the phi coefficient is 0.27 / 0.69. All radiologically proven tip-fold-overs were reliably identified with the intraoperative screening (sensitivity = 100%). A higher specificity (>95%) can be achieved only with measurements via electrode 22. CONCLUSIONS: The TFO Screening via measurement at electrode 22 can successfully distinguish between a correct and incorrect position of the electrode array due to a tip-fold-over, and the remaining cases would require further imaging.