Bone-anchored hearing implants in single-sided deafness patients: Long-term use and satisfaction by gender

Faber, Hubert T.; Nelissen, Rik C.; Kramer, Sophia E.; Cremers, C.W.R.J.; Snik, A.F.M.; Hol, Myrthe K. S.

doi:10.1002/lary.25423

Cited by 12 publications

(5 citation statements)

References 20 publications

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“…Although the QoL benefit in this subgroup did not differ between the interventions, the results found here do correspond to APHAB outcomes previously presented (33). This remains to be a point of attention in expectation management, future evaluation, and patient counseling (34). Another finding was that the cost difference observed during the first year in the different subgroups might differ.…”

Section: Patient Hl Use Patterns and Expected Benefitssupporting

confidence: 76%

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

Hoof

Wigren²,

Blechert³

et al. 2020

Front. Neurol.

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Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control).Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL e86 (CI −50.33; 219.20), FR e134 (CI −3.63; 261.30), ES e178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE e-29 CI −160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to e17 (CI −191.80; 213.30) in the Netherlands, in Spain to e84.50 (CI −117.90; 289.50), and in France to van Hoof et al. CCA of Less Invasive Treatment e80 (CI −99.40; 248.50). The mean additional cost in Sweden increased to e-116 (CI −326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician.Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha ® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

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Section: Patient Hl Use Patterns and Expected Benefitssupporting

confidence: 76%

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

Hoof

Wigren²,

Blechert³

et al. 2020

Front. Neurol.

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“…Potentially, these factors may be playing an important role in cost-utility or effectiveness. Moreover, BCHI recipients consist of a diverse complex population that might broadly differ in experienced benefit (e.g., SSD subjects [57]). Arguably, it might turn out that the ICECAP adds an important new dimension to consider with the availability of transcutaneous solutions as well.…”

Section: Discussionmentioning

confidence: 99%

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Calon

Hoof

Berge

et al. 2016

Trials

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BackgroundOver the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.MethodsA multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression.The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.DiscussionThis is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.Trial registrationRegistered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14. Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618. This trial is sponsored by Oticon Medical AB.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users.

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“…The BAHS is considered a successful treatment option with overall good outcomes. It is an established therapy for patients suffering from several types of hearing loss including conductive hearing loss, mixed hearing loss, and single sided deafness (Snik et al, 2005; Faber et al, 2015). During the last years, treatment options have become less invasive, resulting in improved outcomes regarding esthetics, pain, numbness of the skin, implant survival, and soft tissue reactions (Hultcrantz, 2013; den Besten et al, 2016; Calon et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

Microbiome on the Bone-Anchored Hearing System: A Prospective Study

et al. 2019

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The bone-anchored hearing system (BAHS) has evolved to a common treatment option for various types of hearing revalidation. The BAHS consists of an implant in the skull that breeches the skin. Soft tissue reactions are a common complication associated with BAHS and are generally poorly understood. This study aims to investigate the influence of BAHS and associated skin reactions around the implant. A total of 45 patients were prospectively followed from implantation up to at least 1 year. Swabs were obtained at baseline, 12 weeks follow-up and during cases of inflammation (Holgers score ≥2). The microbiota was assessed using IS-pro TM , a bacterial profiling method based on the interspace region between the 16S–23S rRNA genes. Detection of operational taxonomic units, the Shannon Diversity Index, sample similarity analyses and Partial Least Squares Discriminant Analysis (PLS-DA) were employed. Staphylococcus epidermidis , Streptococcus pneumoniae/mitis , Propionibacterium acnes , Staphylococcus capitis , Staphylococcus hominis , Bifidobacterium longum , Haemophilus parainfluenzae , Lactobacillus rhamnosus , Bordetella spp., Streptococcus sanguinis , Peptostreptococcus anaerobius , Staphylococcus aureus , Lactococcus lactis , Enterobacter cloacae , and Citrobacter koseri were the most commonly found bacterial species. S. pneumoniae/mitis was significantly more often observed after implantation, whereas P. acnes was significantly less observed after implantation compared with baseline. The relative abundance of S. epidermidis (17%) and S. aureus (19.4%) was the highest for the group of patients with inflammation. The Shannon Diversity Index was significantly increased after implantation compared with pre-surgical swabs for Firmicutes, Actinobacteria, Fusobacteria, Verrucomicrobia (FAFV), but not for other phyla. When combining all phyla, there was no significant increase in the Shannon Diversity Index. The diversity index was similar post-surgically for patients experiencing inflammation and for patients without inflammation. With a supervised classifier (PLS-DA), patients prone to inflammation could be identified at baseline with an accuracy of 91.7%. In addition, PLS-DA could classify post-surgical abutments as non-inflamed or inflamed with an accuracy of 97.7%. This study shows the potential of using IS-pro TM to describe and quantify the microbiota associated with the percutaneous BAHS. Furthermore, the results indicate the possibility of an early identification of patients susceptible to adverse skin reaction following implantatio...

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Bone-anchored hearing implants in single-sided deafness patients: Long-term use and satisfaction by gender

Abstract: 3b.

Cited by 12 publications

References 20 publications

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Microbiome on the Bone-Anchored Hearing System: A Prospective Study

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