Abstract
PurposeEvaluating 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.MethodsIn 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.ResultsTwenty-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.ConclusionThe response thresholds recorded in this set-up have the potential to predict the VSB coupling quality and optimize postoperative audiological results.
Highlights
Active middle ear implants (AMEIs) have become an appropriate solution for hearing rehabilitation in patients with moderate to severe sensorineural or mixed hearing loss who cannot use conventional hearing aids due to technical issues such as feedback or sound distortion, or patient-related issues like recurrent infections of the auditory canal [1]
The output could not be recorded for auditory brainstem responses (ABRs) stimulus intensities lower than 30 dB nHL for 0 dB HL bone conduction (BC) setting and lower than 15 dB nHL for 20 dB HL BC setting of the AP404
The results of the multicenter study show that the introduced method was applicable for measuring intraoperative auditory brainstem responses to stimulation by a Vibrant Soundbridge middle ear implant in a series of patients at different centers and with different coupling modalities
Summary
Active middle ear implants (AMEIs) have become an appropriate solution for hearing rehabilitation in patients with moderate to severe sensorineural or mixed hearing loss who cannot use conventional hearing aids due to technical issues such as feedback or sound distortion, or patient-related issues like recurrent infections of the auditory canal [1]. When the VSB was originally designed for treatment of sensorineural hearing loss, the only option to couple the FMT to the middle ear was to crimp it onto the long process of the incus [4]. The indication criteria have been considerably extended, including patients with conductive or mixed hearing loss, since the direct drive stimulation overcomes the patient’s conductive hearing loss and provides a more efficient sound transfer than can be achieved with conventional hearing aids [5, 6]. The FMT can be coupled to the long process (LP) of the incus [4], the short process (SP) of the incus [7], the stapes suprastructure, the round window (RW) membrane [8], or the oval window (OW) [9, 10], i.e., the stapes footplate
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