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.

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.

Active Middle Ear Implant Evoked Auditory Brainstem Response Intensity-Latency Characteristics.

OBJECTIVE: To analyze intensity-latency functions of intraoperative auditory evoked brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant with respect to coupling efficiency, VSB evoked ABR thresholds, and coupling modality [oval window (OW) placement vs. Incus placement and vs. round window (RW) placement]. STUDY DESIGN: Exploratory study. SETTING: Bi-centric study at tertiary referral centers. PATIENTS: Twenty-four patients (10 female, 14 male, mean age: 58 years) who received a VSB. OUTCOME MEASURES: Wave-V intensity-latency functions of intraoperative VSB evoked ABRs using a modified audio processor programmed to preoperative bone conduction thresholds for stimulation. Threshold level correction to coupling efficiency and ABR thresholds. Individual plots and exponential function fits. RESULTS: After ABR threshold level correction, the latency functions could be aligned. A large variance of latencies was observed at individual threshold level. Wave-V latency was longest in the Incus placement subgroup (9.73 ms, SD: 1.04) as compared to OW placement subgroup (9.47 ms, SD: 1.05), with the shortest latency in the RW placement subgroup (8.99 ms, SD: 0.68). For increasing stimulation levels, the variance decreased with intensity-latency function slopes converging toward a steady-state (saturation) latency caused by saturation of audio processor (stimulation) gain. Latency saturation was reached at a stimulation level of 50 dB nHL for the OW placement subgroup, 35 dB nHL for the Incus placement subgroup, and 30 dB nHL for the RW placement subgroup. The latency and saturation results indicated decreased dynamic range for RW placement, i.e., reverse stimulation. CONCLUSIONS: VSB evoked ABR wave-V intensity-latency function slopes were similar to acoustic stimulation at high stimulation levels with a shift toward longer latencies caused by audio processor signal delay. Saturation of latencies occurred for higher stimulation levels due to saturation of audio processor gain. Thus, the analysis of VSB evoked intensity-latency functions appears to allow for the objective assessment of a patient's individual dynamic range. This can further improve diagnostics as well as intraoperative and postoperative quality control.

Evaluation of a synthetic version of the digits-in-noise test and its characteristics in CI recipients.

OBJECTIVE: The goal of this study was the evaluation of a synthetic version of the Digits-in-Noise (DiN) in participants with normal hearing. Additionally, the basis characteristics of the DiN in CI recipients were investigated. DESIGN AND STUDY SAMPLE: Twenty participants with normal hearing and 21 CI recipients with a Nucleus®-System ran two to three adaptive and up to five fixed measurements. Afterwards the discrimination function was measured with fixed signal-to-noise ratios. RESULTS: All subjects were able to perform the DiN within three minutes per test run. The median speech reception threshold (SRT) for the NH was -8.1 dBSNR, with a median steepness of 23%/dBSNR. The median absolute test-retest difference in the NH group was 0.4 dB (range: 0 to 1.5 dB). In the CI group, the SRTs range from -6.6 to +12.4 dBSNR with a median test-retest difference of 0.4 dB (range: 0 to 6.1 dB). CONCLUSION: The synthetic DiN is a valuable complement of the audiometric test battery in CI recipients. The excellent applicability is also particularly helpful in poor performing CI recipients. With its small time exposure, it is a time- and cost-saving test, which could also be used at home via app to check the individual hearing success.