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      Minimally invasive surgery as a new clinical standard for bone anchored hearing implants—real-world data from 10 years of follow-up and 228 surgeries

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          Abstract

          Purpose

          To explore the clinical practice development of different surgical techniques when installing bone-anchored hearing implants and their associated trends in outcomes.

          Design

          Retrospective study of 228 bone-anchored hearing implants in 200 patients, performed over a 10-year period between 2012 and 2022 in a referral hospital.

          Method

          Real-world data of demography, etiology, surgical setup, complications, and audiological outcomes were collected. Eligibility criteria from clinical practice were applied.

          Results

          The minimally invasive technique is associated with shorter surgery duration, 20 vs. 44 min as compared to a linear incision technique. The minimally invasive technique was also associated with a lower occurrence of complications when compared to linear incision techniques (intraoperative; 1.8% vs. 4.9%, postoperative; 49% vs. 66%). Most differences were seen in complications relating to skin and wound healing.

          Conclusion

          Adoption of a minimally invasive surgical technique for the installations of bone-anchored hearing implants can reduce surgical complexity without compromising safety aspects or clinical benefits.

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          Most cited references26

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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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            Soft tissue reactions around percutaneous implants: a clinical study of soft tissue conditions around skin-penetrating titanium implants for bone-anchored hearing aids.

            Some patients with hearing impairment cannot use conventional hearing aids. One solution for these patients is the use of bone conduction hearing aids; however, this kind of equipment is associated with several problems related to the necessity for a good contact between the transducer and the temporal bone. Direct bone contact would be an ideal solution provided that safe and reaction-free skin penetration and a safe and permanent bone anchorage could be achieved. Brånemark et al have developed a procedure to furnish edentulous patients with fixed bridges using titanium implants. This report is focused on the clinical status of the soft tissue adjacent to the 67 skin-penetrating devices in 60 patients. The patients have been followed between 3 and 96 months on 313 occasions, which represents a total observation time of 1515 months of clinical performance. Only one implant was extracted due to adverse skin reaction, giving a failure rate of 0.07% per month. This is comparable with the failure rate of cardiac pacemakers 0.02-0.04% per month).
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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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                Author and article information

                Contributors
                Journal
                Front Surg
                Front Surg
                Front. Surg.
                Frontiers in Surgery
                Frontiers Media S.A.
                2296-875X
                03 July 2023
                2023
                : 10
                : 1209927
                Affiliations
                [ 1 ]Department of Ophthalmology, Otorhinolaryngology, Head and Neck Surgery, Ribeirão Preto Medical School, University of São Paulo , Ribeirão Preto, Brazil
                [ 2 ]Department of Health Sciences, RCS, Ribeirão Preto Medical School, University of São Paulo , Ribeirão Preto, Brazil
                [ 3 ]Clinical Department, Oticon Medical , São Paulo, Brazil
                [ 4 ]Clinical Department, Oticon Medical , Askim, Sweden
                [ 5 ]Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Gothenburg, Sweden
                [ 6 ]Research and Technology Department, Oticon Medical , Askim, Sweden
                Author notes

                Edited by: Jack Wazen, Sarasota Memorial Hospital, United States

                Reviewed by: Philip Rajan, Raja Permaisuri Bainun Hospital, Malaysia Hans Thomeer, University Medical Center Utrecht, Netherlands Tim G. A. Calon, Radboud University Medical Centre, Netherlands

                [* ] Correspondence: Martin Lars Johansson martin.johansson@ 123456biomaterials.gu.se
                Article
                10.3389/fsurg.2023.1209927
                10351910
                37465065
                c084296c-2c94-4ea6-8c08-b8cda53a2edf
                © 2023 Cruz, Danieli, Håkansson, Johansson, dos Santos, Mirândola Barbosa Reis and Hyppolito.

                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
                : 21 April 2023
                : 21 June 2023
                Page count
                Figures: 3, Tables: 4, Equations: 0, References: 27, Pages: 0, Words: 0
                Categories
                Surgery
                Original Research
                Custom metadata
                Otorhinolaryngology - Head and Neck Surgery

                bone conduction implant,minimally invasive surgery,osseointegrated hearing aid,real-world data,bone-anchored hearing system (bahs),ponto

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