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      Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children

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          Abstract

          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s00405-023-07927-9.

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          Most cited references28

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          New developments in bone-conduction hearing implants: a review

          The different kinds of bone-conduction devices (BCDs) available for hearing rehabilitation are growing. In this paper, all BCDs currently available or in clinical trials will be described in categories according to their principles. BCDs that vibrate the bone via the skin are referred to as skin-drive devices, and are divided into conventional devices, which are attached with softbands, for example, and passive transcutaneous devices, which have implanted magnets. BCDs that directly stimulate the bone are referred to as direct-drive devices, and are further divided into percutaneous and active transcutaneous devices; the latter have implanted transducers directly stimulating the bone under intact skin. The percutaneous direct-drive device is known as a bone-anchored hearing aid, which is the BCD that has the largest part of the market today. Because of some issues associated with the percutaneous implant, and to some extent because of esthetics, more transcutaneous solutions with intact skin are being developed today, both in the skin-drive and in the direct-drive category. Challenges in developing transcutaneous BCDs are mostly to do with power, attachment, invasiveness, and magnetic resonance imaging compatibility. In the future, the authors assume that the existing percutaneous direct-drive BCD will be retained as an important rehabilitation alternative, while the transcutaneous solutions will increase their part of the market, especially for patients with bone-conduction thresholds better than 35 dB HL (hearing level). Furthermore, the active transcutaneous direct-drive BCDs appear to be the most promising systems, but to establish more detailed inclusion criteria, and potential benefits and drawbacks, more extensive clinical studies are needed.
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            First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy.

            To investigate safety and efficacy of a new transcutaneous bone conduction hearing implant, over a 3-month follow-up period.
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              The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature.

              Hearing aids and implants employing bone conduction (BC) stimulation have a long tradition in the treatment of conductive or mixed hearing loss, with their indications being extended in the 2000s to include single-sided deafness (SSD). Existing percutaneous bone conduction implants (BCI) provide significant audiological gain but are associated with a high rate of complications. This has led to the development of passive transcutaneous BCIs; however, audiological benefit may be compromised. An active transcutaneous BCI, the Bonebridge, was recently introduced and first implanted in 2011 as part of a clinical trial.
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                Author and article information

                Contributors
                willenborg.kerstin@mh-hannover.de
                Journal
                Eur Arch Otorhinolaryngol
                Eur Arch Otorhinolaryngol
                European Archives of Oto-Rhino-Laryngology
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0937-4477
                1434-4726
                31 March 2023
                31 March 2023
                2023
                : 280
                : 10
                : 4381-4389
                Affiliations
                [1 ]GRID grid.10423.34, ISNI 0000 0000 9529 9877, Department of Otolaryngology, , Hannover Medical School, ; Carl-Neuberg-Str. 1, 30625 Hannover, Germany
                [2 ]Cluster of Excellence H4A, Hannover, Germany
                Author information
                http://orcid.org/0000-0003-3610-8622
                Article
                7927
                10.1007/s00405-023-07927-9
                10477095
                37000276
                576baf7d-b6d2-49ba-ab84-046afd2fa3e3
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 5 February 2023
                : 13 March 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001659, Deutsche Forschungsgemeinschaft;
                Award ID: Germany's Excellence Strategy EXC 2177/1 "Hearing4all 2.0" Project ID 390895286
                Award Recipient :
                Funded by: Medizinische Hochschule Hannover (MHH) (3118)
                Categories
                Otology
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2023

                Otolaryngology
                bone conduction implant,children,conductive hearing loss,bone thickness,bci 602
                Otolaryngology
                bone conduction implant, children, conductive hearing loss, bone thickness, bci 602

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