Purpose Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance. Methods In this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software. Results All patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance. Conclusion With adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children.
<b><i>Objective:</i></b> The Cochlear™ Osia® System (Osia) is an active transcutaneous bone conduction implant system intended for patients with conductive and mixed hearing loss but can also be used in cases of single-sided deafness (SSD) for the contralateral routing of signal (CROS). The Osia implant is placed subcutaneously under the intact skin behind the ear with the piezoelectric actuator connected to an osseointegrated BI300 implant – a titanium screw used for a 2-stage Baha surgery – on the mastoid. The external processor is magnetically attached to the subcutaneous implant receiver coil. As the Osia has recently been CE certified and is new on the market, with limited patient outcome data for SSD available, the objective of this study was the evaluation of surgical procedure, audiological results, and patient satisfaction for the Osia in SSD patients. <b><i>Study Design:</i></b> In a prospective, monocentric clinical observation study, 6 patients (18 years of age or older) with SSD and bone conduction thresholds pure tone average 0.5, 1, 2, and 4 kHz ≤25 dB HL on the contralateral side were implanted with an Osia. Analysis of clinical outcome data with respect to surgical technique, adverse events, audiological measurement, and subjective benefit for SSD patients was conducted. Audiological measurements performed included hearing thresholds, sound field thresholds, word recognition scores (WRS; in %) in quiet, and speech recognition thresholds in noise (in dB SNR). All tests were performed unaided and aided with the Osia. The subjective benefit with the Osia was determined by using 2 questionnaires; the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSSD). <b><i>Results:</i></b> Preliminary results indicate a straightforward surgical procedure with a low rate of complications and an improvement in speech perception in quiet, listening performance in everyday situations and patient satisfaction. However, in one of 6 subjects, a revision surgery had to be performed. <b><i>Conclusion:</i></b> Provided that SSD patients are open for CROS hearing, they can benefit from the Osia by reduced head shadow effects and better speech recognition. Special caution should be given to the skin at the site of implantation to avoid complications.
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