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      Ex vivo Evaluation of a New Drill System for Placement of Percutaneous Bone Conduction Devices

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          Abstract

          The procedure for installation of a percutaneous bone-conducting device has undergone significant improvements since its introduction 40 years ago. Today, the linear incision technique with tissue preservation (LITT-P) and the minimally invasive procedure (MIPS) are the most commonly used approaches. In both these techniques, a gradual increase of the osteotomy using a three-step drilling sequence is utilized, as this approach can allow a stepwise deepening and widening of the osteotomy in the mastoid and can prevent bone overheating. A new minimally invasive procedure (MONO) has been developed that allows an osteotomy to be performed and enables complete removal of the bone volume in one single drill step for a 4 mm implant using a novel parabolic twist drill. Here, the feasibility of the MONO procedure was qualitatively and quantitatively evaluated in terms of the dura response to drill trauma in comparison with the outcomes achieved with guide drills used for the LITT-P and MIPS techniques. Fresh frozen temporal bone from a human cadaver was subjected to penetration by three drills beyond the base of the mastoid bone to different depths. The sites were evaluated, and the damage to and possible penetration of the dura were determined. The results showed that for a drill depth exceeding mastoid bone thickness by not more than 1 mm, damage to the dura was limited or nonexistent, whereas for a drill depth exceeding bone thickness by 2 mm, damage increased, or the dura was penetrated. There was a trend toward more damage and penetration for both the round burr and MIPS guide drill compared with the MONO drill bit. From this experimental ex vivo study, it can be concluded that if the dura is encountered, the MONO system is not more inclined to penetrate the dura than the conventional LITT-P and MIPS systems.

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          Most cited references43

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          Osseointegrated titanium implants in the temporal bone. A clinical study on bone-anchored hearing aids.

          The purpose of this study is to investigate the possibilities for attaching a new type of direct bone conduction hearing aid. Using a gentle surgical technique, titanium screws were inserted into the temporal bone of fourteen patients suffering from hearing impairment. The implants became integrated with the living bone tissue and have remained so for a follow-up period of, at present, two to four years. It is therefore concluded that titanium implants may be osseointegrated in the temporal bone in a similar manner to that previously described for long bones. The bone-anchored titanium screws were connected to a permanently skin-penetrating abutment, which in turn was used for attachment to a hearing aid. In this way a direct bone conduction without obstructing soft tissue layers is secured. The permanent skin penetration caused no adverse soft tissue effects. The new system has improved pure-tone hearing threshold by about 15 dB. Further research is aimed at the construction of a new hearing aid that is better adapted to the impedance situation existing in the directly bone-anchored cases.
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            Outcome of the bone-anchored hearing aid procedure without skin thinning: a prospective clinical trial.

            To evaluate the outcome of Bone-Anchored Hearing Aid surgery without skin thinning, a test group with direct implantation without such thinning was compared with a control group that underwent the traditional procedure.
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              A meta-analysis of the complications associated with osseointegrated hearing aids.

              To summarize available peer-reviewed literature to describe the range and rate of complications related to osseointegrated hearing aids in adult and pediatric patients. We searched PubMed using the terms bone-anchored hearing aid for articles published in English between 2000 and 2011. We included all articles reporting complications rates, except those that were case reports, general review (not systematic review), or commentary, as well as those that did not include patient outcomes, that reported outcomes associated with nonstandard implantation (e.g., 8.5-mm abutment) or were of poor study or reporting quality. After excluding articles that did not meet criteria, 20 articles were identified, comprising 2,134 patients who underwent a total of 2,310 osseoimplants. Complications reported in the literature were typically minor in nature. Skin reactions from Holgers Grade 2 to 4 ranged from 2.4% to 38.1%. Failure of osseointegration ranged from 0% to 18% in adult and mixed populations, and 0% to 14.3% in pediatric populations. The rate of revision surgery ranges from 1.7% to 34.5% in adult and mixed populations and 0.0% to 44.4% in pediatric patients, whereas the total rate of implant loss ranged from 1.6% to 17.4% in adult and mixed populations and from 0.0% to 25% in pediatric patients. Overall, the quality of large scale and/or prospective studies reporting the incidence of complications after osseointegrated hearing aid surgery is poor and lacks uniformity. However, based on available data, which shows a lack of major complications, osseointegrated implantation is a safe procedure in both adult and pediatric populations. Well-designed, prospective studies with uniform reporting standards would allow greater comparison between techniques and more reliable analysis of complications of osseointegration surgery of the temporal bone for cochlear stimulation.
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                Author and article information

                Contributors
                Journal
                Front Surg
                Front Surg
                Front. Surg.
                Frontiers in Surgery
                Frontiers Media S.A.
                2296-875X
                21 March 2022
                2022
                : 9
                : 858117
                Affiliations
                [1] 1Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Centre Utrecht , Utrecht, Netherlands
                [2] 2University Medical Centre Utrecht Brain Centre, University of Utrecht , Utrecht, Netherlands
                [3] 3Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Gothenburg, Sweden
                [4] 4Research and Technology, Oticon Medical AB , Askim, Sweden
                Author notes

                Edited by: Małgorzata Wierzbicka, Poznan University of Medical Sciences, Poland

                Reviewed by: Prem Sagar, All India Institute of Medical Sciences, India; Maurizio Barbara, Sapienza University of Rome, Italy

                *Correspondence: Martin L. Johansson martin.johansson@ 123456biomaterials.gu.se

                This article was submitted to Otorhinolaryngology-Head and Neck Surgery, a section of the journal Frontiers in Surgery

                Article
                10.3389/fsurg.2022.858117
                8977416
                35388366
                a5be067c-58fb-48d0-8982-88c54c8a30c3
                Copyright © 2022 Strijbos, Straatman, Stokroos and Johansson.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 19 January 2022
                : 14 February 2022
                Page count
                Figures: 3, Tables: 1, Equations: 0, References: 43, Pages: 9, Words: 5832
                Funding
                Funded by: Vetenskapsrådet, doi 10.13039/501100004359;
                Award ID: 2018-02891
                Award ID: 2020-04715
                Funded by: Oticon Medical, doi 10.13039/501100020045;
                Funded by: Adlerbertska Research Foundation, doi 10.13039/501100014552;
                Funded by: Stiftelsen Handlanden Hjalmar Svenssons, doi 10.13039/501100003744;
                Funded by: IngaBritt och Arne Lundbergs Forskningsstiftelse, doi 10.13039/501100003849;
                Categories
                Surgery
                Original Research

                dura,bahs,bone drilling,osteotomy and drilling guides,bone anchored hearing,surgical procedures,bone conduction,minimally invasive

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