Neuromod gains CE Mark approval for tinnitus device | Regulatory news for the week of December 1, 2014

Here's a look at some of the top regulatory stories for medical device companies this week: Neuromod wins CE Mark for tinnitus device; Vascular Solutions wins FDA nod for Gel-Block embolization foam; Philips wins FDA clearance for IQon Spectral CT system; EU allows GI Dynamics EndoBarrier back on the market; Diabetes: FDA approves Animas Vibe with DexCom's G4 Platinum CGM Neuromod wins CE Mark for tinnitus device November 26, 2014 by Val Kennedy Animas, DexCom Inc., Food &Drug Administration (FDA), Johnson &Johnson, Neuromod Devices, Philips Healthcare, Vascular Solutions Inc., GI DynamicsNews Well, Regulatory/Complianceread more
Source: Mass Device - Category: Medical Equipment Authors: Source Type: news

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Introduction to the Theme "New Therapeutic Targets". Annu Rev Pharmacol Toxicol. 2019 Jan 06;59:15-20 Authors: Insel PA, Amara SG, Blaschke TF, Meyer UA Abstract "New Therapeutic Targets" is the theme of articles in the Annual Review of Pharmacology and Toxicology, Volume 59. Reviews in this volume discuss targets for a variety of conditions in need of new therapies, including type 2 diabetes, heart failure with preserved ejection fraction, obesity, thyroid-associated ophthalmopathy, tinnitus, multiple sclerosis, Parkinson's disease and other neurodegenerative diseases, pain, depre...
Source: Annual Review of Pharmacology and Toxicology - Category: Drugs & Pharmacology Authors: Tags: Annu Rev Pharmacol Toxicol Source Type: research
In Reply We thank Dr Wu and colleagues for their interest and comments on our research. Various factors may affect hearing recovery after SSHL, such as age, degree of hearing loss, type of hearing loss, interval from onset of symptoms to treatment, tinnitus, type 2 diabetes, cardiovascular disease, and the presence of vertigo. We were unable to include the hearing level at onset into our analyses owing to the lack of corresponding data in the included studies. Moreover, only 1 of the included studies assessed the possible association between the presence of vertigo and hearing recovery in patients with severe sudden sensor...
Source: JAMA Otolaryngology - Head and Neck Surgery - Category: ENT & OMF Source Type: research
Conclusions: Risk factors for poor hearing recovery in ALFHL included longer symptom duration and 1 kHz involvement. In ALFHL with such risk factors, combination therapy was more effective than oral steroid therapy.
Source: Otology and Neurotology - Category: ENT & OMF Tags: SENSORINEURAL HEARING LOSS AND TINNITUS Source Type: research
ConclusionsCurrent therapeutic strategies have proven that the goal of the traditional oriental medicine principle of increasing bodily fluids is a relevant approach for reducing the development of hearing loss by improving microcirculation in the blood-labyrinth barrier and increasing cochlear blood flow. The potential benefits of TOM agents expand to a multi-target approach on different auditory structures of the inner ear related to increased cochlear blood flow, antioxidant, anti-inflammatory, anti-apoptotic and neuroprotective activities. TOM is proposed as an important source of drug discovery and well-controlled, do...
Source: Journal of Ethnopharmacology - Category: Drugs & Pharmacology Source Type: research
AbstractThis systematic review and meta-analysis aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (ICBT) on anxiety and depression among persons with chronic health conditions. A systematic database search was conducted of MEDLINE, CINAHL, PsycInfo, EMBASE, and Cochrane for relevant studies published from 1990 to September 2018. A study was included if the following criteria were met: (1) randomized controlled trial involving an ICBT intervention; (2) participants experienced a chronic health condition; (3) participants ≥ 18 years of age; and (4) effects of ICBT on anxie...
Source: Journal of Behavioral Medicine - Category: Psychiatry Source Type: research
Objectives: To investigate the risk of stroke in SSNHL patients. Study Design: A longitudinal follow-up cohort study. Setting: The Korean National Health Insurance Service-National Sample Cohort from 2002 to 2013. Patients: The 4,944 SSNHL participants were matched with 19,776 controls for age, sex, income, region of residence, hypertension, diabetes, and dyslipidemia. The SSNHL subjects were diagnosed (International Classification of Disease [ICD]-10: H91.2), underwent an audiometry examination, and were treated with steroids. The history of hemorrhagic stroke, ischemic stroke, hypertension, diabetes, dyslipide...
Source: Otology and Neurotology - Category: ENT & OMF Tags: Sens Orineural Hearing Loss and Tinnitus Source Type: research
Abstract We performed a cluster analysis to classify the audiogram shape in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). We also investigated whether the audiogram shape is a prognostic indicator in the management of ISSNHL. A total of 115 inpatients with ISSNHL treated between 2001 and 2010 were analyzed. The data collected included age, sex, duration of hearing loss at the time of treatment, and the presence or absence of tinnitus, vertigo, diabetes, nystagmus, and canal paresis. A hierarchical cluster analysis was performed using the hearing threshold for each frequency on audiograms as ...
Source: Ear, Nose and Throat Journal - Category: ENT & OMF Authors: Tags: Ear Nose Throat J Source Type: research
thge Elizabet Paunović Following the Parma Declaration on Environment and Health adopted at the Fifth Ministerial Conference (2010), the Ministers and representatives of Member States in the WHO European Region requested the World Health Organization (WHO) to develop updated guidelines on environmental noise, and called upon all stakeholders to reduce children’s exposure to noise, including that from personal electronic devices. The WHO Environmental Noise Guidelines for the European Region will provide evidence-based policy guidance to Member States on protecting human health from noise originating from t...
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Project Report Source Type: research
Authors: Kang SM, Lim HW, Yu H Abstract Although sudden sensorineural hearing loss (SSNHL) affects chronic kidney disease (CKD) patients more frequently than non-CKD patients, few reports have described SSNHL in dialysis patients. We aimed to review the characteristics of SSNHL in chronic dialysis patients and evaluate treatment responses to steroid therapy. We retrospectively reviewed the records of dialysis patients diagnosed with idiopathic SSNHL at Asan Medical Center between January 2000 and December 2014. Pure tone and speech audiometry analyzes were performed before and 2 weeks and 2 months aft...
Source: Renal Failure - Category: Urology & Nephrology Tags: Ren Fail Source Type: research
CONCLUSIONS: Diabetes is associated with bilateral sensorineural hearing loss, especially at high frequencies. While pre-diabetes is not necessarily associated with significant hearing loss, there may be cochlear malfunction, as indicated by DPOAEs. Thus, patients with pre-diabetes who have tinnitus may benefit from DPOAEs and PTA tests. PMID: 29347860 [PubMed - as supplied by publisher]
Source: Acta Oto-Laryngologica - Category: ENT & OMF Authors: Tags: Acta Otolaryngol Source Type: research
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