A New Active Osseointegrated Implant System in Patients with Single-Sided Deafness

Abstract

<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.

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

“…Osia does also provide a benefit for speech recognition in noise [4,8]. Subjective evaluation using the SSQ, APHAB, and HUI showed benefit for Osia recipients [8,[11][12][13], and our long-term data revealed the largest benefit at > 36 months of Osia experience.…”

Bone-Anchored Hearing Devices for Single-Sided Deafness: A New Preoperative Evaluation Protocol and Widening of Indications Proposal

“…Cochlear implantation for SSD cases represents a new ongoing indication for many national guidelines, still with the problem of different quality of stimulation between two sides, with robotic-like perceived words and phrases on the implanted side and normal ones on the opposite side, and its limitations for aged single-sided defects due to the opposite side cortical structures' loss of capacity to manage language information [Oh et al, 2022]. Bone-anchored hearing devices (BAHD) represent a good solution, which is well tolerated and effective, with minor costs and risks of complication during surgery than cochlear implantation ones, also thanks to the recent improvements concerning implanted transducer based models, as Cochlear ® Osia (Cochlear ® , Sydney, Australia) and Med-El ® Bonebridge (Med-El ® , Innsbruck, Austria), which allow extension of indications up to 65 dB bone conduction (BC) threshold on the implanted side for conductive hearing defects [Seiwerth et al, 2022;Willenborg et al, 2022]. Despite this power extension and the slight BC interaural attenuation of only 5-10 dB, indications for BAHD in SSD cases still remain limited for cases with 20-25 dB or better BC thresholds on the normal hearing side [Ellsperman et al, 2021].…”

Modifications to Implanting the OSIA® 2 Bone Conduction Hearing Implant: How I Do it

“…Though complications for the OSIA procedure are low, potential issues include wound breakdown, infection, hematoma, dural injury, or difficulty with magnet retention. 2,3 The authors present their experience with implanting the OSIA 2 system and discuss modifications that are made in certain situations to further reduce these potential complications and simplify surgical placement.…”