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Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

ABSTRACT: BACKGROUND:Bone-anchored hearing systems (BAHSs) are widely used for hearing rehabilitation and are indicated in cases of conductive and mixed hearing loss and in single-sided deafness. The Ponto system, that is one available option, has been on the market since 2009. OBJECTIVE OF REVIEW:The aim of this study is to systematically review the literature reporting on the Ponto system, with regard to audiological and surgical outcomes and patient's quality-of-life scores. TYPE OF REVIEW:A systematic literature search was performed in the PubMed database 2009-July 2019. SEARCH STRATEGY:Search term: ((osseointegrated hearing aid) OR (bone conduction implant) OR (bone anchored hearing) OR BAHA OR BAHS OR BAHI). Pre-defined inclusion and exclusion criteria were applied. EVALUATION METHOD:English-language articles reporting original clinical data (audiological, surgical or quality-of-life outcomes) on the Ponto system were included. Articles reporting on Ponto and another BAHS system where the results on Ponto constituted less than 50% of the patient population or including only results on testband or softband devices were excluded. RESULTS:Audiological outcomes were discussed in 20 publications. Improvement against the unaided thresholds was demonstrated. The functional improvement was on average 33.9 dB. The effective gain or remaining air-bone gap was on average 6.7 dB. All evaluated data showed aided speech reception thresholds significantly below normal speech level. Twenty-seven publications reported surgical and follow-up data for the Ponto system. Implant survival was 97.7%, adverse skin reactions (Holgers ? 2) were 5% across visits and 15% across patients. No complications were life-threatening, causing permanent disability/damage or requiring a hospitalisation. Five studies reported quality of life using the Glasgow benefit inventory, 98% reported an improvement when analysing the score on an individual level. CONCLUSIONS:The outcomes of this systematic review confirm that percutaneous systems provide consistent audiological benefits and improved quality of life for patients. Further, the review demonstrates that the percutaneous systems are safe, with relatively low complication rates. Skin-related complications are the most common complication type and are experienced by approximately one patient out of seven, or in less than one of 20 follow-up visits.

SUBMITTER: Lagerkvist H

PROVIDER: S-EPMC7496709 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

Lagerkvist Helén H Carvalho Karin K Holmberg Marcus M Petersson Ulrika U Cremers Cor C Hultcrantz Malou M

Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery 20200525 5

<h4>Background</h4>Bone-anchored hearing systems (BAHSs) are widely used for hearing rehabilitation and are indicated in cases of conductive and mixed hearing loss and in single-sided deafness. The Ponto system, that is one available option, has been on the market since 2009.<h4>Objective of review</h4>The aim of this study is to systematically review the literature reporting on the Ponto system, with regard to audiological and surgical outcomes and patient's quality-of-life scores.<h4>Type of r ...[more]

PMID: 32386454

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Project description: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-proTM, 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-proTM 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 implantation. Both S. aureus and S. epidermidis should be considered as relevant bacteria for BAHS-associated inflammation.

Project description:OBJECTIVE:To study the effect of implanting the percutaneous bone-anchored hearing system (BAHS) itself and inflammation of the peri-abutment skin warrant clarification. In this study, we aimed to acquire further insight into the immune responses related to BAHS surgery and peri-implant skin inflammation. MATERIALS AND METHODS:During surgery and 12 weeks post-implantation, skin biopsies were obtained. If applicable, additional biopsies were taken during cases of inflammation. The mRNA expression of IL-1?, IL-6, IL-8, TNF?, IL-17, IL-10, TGF-ß, MIP-1?, MMP-9, TIMP-1, COL1?1, VEGF-A, FGF-2 TLR-2, and TLR-4 was quantified using qRT-PCR. RESULTS:Thirty-five patients agreed to the surgery and 12-week biopsy. Twenty-two patients had mRNA of sufficient quality for analysis. Ten were fitted with a BAHS using the minimally invasive Ponto surgery technique. Twelve were fitted with a BAHS using the linear incision technique with soft-tissue preservation. Five biopsies were obtained during episodes of inflammation. The post-implantation mRNA expression of IL-1? (P = .002), IL-8 (P = .003), MMP9 (P = .005), TIMP-1 (P = .002), and COL1?1 (P < .001) was significantly up-regulated. IL-6 (P = .009) and FGF-2 (P = .004) mRNA expression was significantly down-regulated after implantation. Within patients, no difference between post-implantation mRNA expression (at 12 weeks) and when inflammation was observed. Between patients, the expression of IL-1? (P = .015) and IL-17 (P = .02) was higher during cases of inflammation compared with patients who had no inflammation at 12-week follow-up. CONCLUSIONS:As part of a randomized, prospective, clinical trial, the present study reports the molecular profile of selected cytokines in the soft tissue around BAHS. Within the limit of this study, the results showed that 12 weeks after BAHS implantation the gene expression of some inflammatory cytokines (IL-8 and IL-1?) is still relatively high compared with the baseline, steady-state, expression. The up-regulation of anabolic (COL1?1) and tissue-remodeling (MMP-9 and TIMP1) genes indicates an ongoing remodeling process after 12 weeks of implantation. The results suggest that IL-1?, IL-17, and TNF-? may be interesting markers associated with inflammation.

Project description:ObjectivesThe purpose of this study was to evaluate the benefits of bilateral implantation for bone-anchored hearing system (BAHS) users in terms of spatial resolution abilities and auditory memory for speech.DesignThis is a prospective, single-center, comparative, single-blinded study where the listeners served as their own control. Twenty-four experienced bone-anchored users with a bilateral conductive or mixed hearing loss participated in the study. After fitting the listeners unilaterally and bilaterally with BAHS sound processor(s) (Ponto 3 SuperPower), spatial resolution was estimated by measuring the minimum audible angle (MAA) to achieve an 80% correct response via a two-alternative-forced choice task (right-left discrimination of noise bursts) in two conditions: both sound processors active (bilateral condition) and only one sound processor active (unilateral condition). In addition, a memory recall test, the Sentence-final Word Identification and Recall (SWIR) test was performed with five lists of seven sentences for each of the two conditions (unilateral and bilateral). Self-reported performance in everyday life with the listener's own sound processors was also evaluated via a questionnaire (the abbreviated version of the Speech, Spatial and Qualities of Hearing scale).ResultsThe MAA to discriminate noise bursts improved significantly from 75.04° in the unilateral condition to 3.61° in the bilateral condition ( p < 0.0001). The average improvement in performance was 54.28°. The SWIR test results showed that the listeners could recall, on average, 55.03% of the last words in a list of seven sentences in the unilateral condition and 57.23% in the bilateral condition. While the main effect of condition was not significant, there was a significant interaction between condition and repetition (list), revealing a significantly higher recall performance in the bilateral condition than in the unilateral condition for the second repetition/list out of five (10.2% difference; p = 0.022). Self-reported performance with bilateral BAHS obtained via the Speech, Spatial and Qualities of Hearing scale questionnaire was, on average, 4.4 for speech, 3.7 for spatial, and 5.1 for qualities of hearing. There was no correlation between self-reported performance in everyday life and bilateral performance in the MAA test, while significant correlations were obtained between self-reported performance and recall performance in the SWIR test.ConclusionsThese results showed a large benefit in spatial resolution for users with symmetric BC thresholds when being fitted with two BAHS, although their self-reported performance with bilateral BAHS in everyday life was rather low. In addition, there was no overall benefit of bilateral fitting on memory for speech, despite observing a benefit in one out of five repetitions of the SWIR test. Performance in the SWIR test was correlated with the users' self-reported performance in everyday life, such that users with higher recall ability reported to achieve better performance in real life. These findings highlight the advantages of bilateral fitting on spatial resolution, although bilaterally fitted BAHS users continue to experience some difficulties in their daily lives, especially when locating sounds, judging distance and movement. More research is needed to support a higher penetration of bilateral BAHS treatment for bilateral conductive and mixed hearing losses.

Project description:Specialized adult care of phenylketonuria (PKU) patients is of increasing importance. Adult outpatient clinics for inherited errors of metabolism can help to achieve this task, but experience is limited. Ten years after establishment of a coordinated transition process and specialised adult care for inherited metabolic diseases, adult PKU care was evaluated with respect to metabolic control, therapy satisfaction, life satisfaction, sociodemographic data, economical welfare as well as pregnancy outcome.All PKU patients transferred from paediatric to adult care between 2005 and 2015 were identified. A retrospective data analysis and a cross-sectional survey in a sub-cohort of 30 patients including a questionnaire for assessing quality of life (FLZm) were performed as a single-centre investigation at the metabolic department of the University Hospital Leipzig, Germany. For statistical analysis, Mann-Whitney-U-test, t-test for independent samples, ANOVA and chi square test were used as appropriate.96 PKU patients (56 females/40 males; median age 32 years, range 18-62) were included. In the last 3-year period, 81% of the transferred patients still kept contact to the adult care centre. Metabolic control was stable over the evaluation period and dried blood phenylalanine concentrations mostly remained within the therapeutic range (median 673.0 ?mol/l, range 213.0-1381.1). Sociodemographic data, economical welfare and life satisfaction data were comparable to data from the general population. However, differences could be revealed when splitting the cohort according to time of diagnosis and to management during childhood. 83% of the PKU adults were satisfied with the transition process and current adult care. 25 completed pregnancies were supervised; three newborns, born after unplanned pregnancy, showed characteristic symptoms of maternal PKU syndrome.Continuous care for adult PKU patients in a specialized outpatient clinic is successful, leading to good to satisfactory metabolic control and social outcomes. Uninterrupted good metabolic treatment throughout childhood and adolescence positively influences educational, professional and economic success in later life. Further effort in specialized paediatric and adult metabolic care is needed to prevent loss of follow-up and to support the recommended life-long treatment and/or care.

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Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

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Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

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