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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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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
Abstract Perceived hearing difficulty (HD) and/or tinnitus in the presence of normal audiometric thresholds present a clinical challenge. Yet, there is limited data regarding prevalence and determinant factors contributing to HD. Here we present estimates generalized to the non-institutionalized population of the United States based on the cross-sectional population-based study, the National Health and Nutrition and Examination Survey (NHANES) in 2176 participants (20-69 years of age). Normal audiometric thresholds were defined by pure-tone average (PTA4) of 0.5, 1.0, 2.0, 4.0 kHz ≤ 25 dBHL ...
Source: Hearing Research - Category: Audiology Authors: Tags: Hear Res Source Type: research
Conclusions In this paper, we reviewed various studies conducted on C. officinalis, especially in areas of its ethnopharmacological use, as well as on its phytochemistry, pharmacology, and modern analytical methods used. Some of the herb’s ethnomedical indications have been confirmed by the herb’s pharmacological effects, such as its hepatic and renal protection and the antidiabetic effects. In particular, the crude extract and its chemical composition have exerted good therapeutic effect in diabetic treatment. C. officinalis entails additional attention on its pharmacological effects and drug development to ex...
Source: Journal of Ethnopharmacology - Category: Drugs & Pharmacology Source Type: research
Int Arch Otorhinolaryngol DOI: 10.1055/s-0037-1606644 Introduction The aging process causes changes in body structure in a continuous manner, and contributes to clinical disorders. Life expectancy is increasing, especially in developing countries. Objective To assess the prevalence of hearing loss and its possible association with hypertension and diabetes mellitus (DM) in the elderly. Methods A cross-sectional study with 519 elderly individuals aged over 60 years who underwent an audiological evaluation (pure tone audiometry), and answered a comorbidity questionnaire that included questions about a...
Source: International Archives of Otorhinolaryngology - Category: ENT & OMF Authors: Tags: Original Research Source Type: research
CONCLUSIONS: Microsurgery represents the first therapeutic option for small growing VS with SUH. Our data confirm that key-hole RS removal of VS with intraoperative LS-CE-Chirp ABR monitoring allows good rate of SUH preservation, especially maximum diameter does not exceed 2cm. Preoperative tinnitus seems to indicate a lower hearing reserve and predicts a lower likelihood of HP. PMID: 28945052 [PubMed - as supplied by publisher]
Source: Journal of Neurosurgical Sciences - Category: Neurosurgery Tags: J Neurosurg Sci Source Type: research
Authors: Messina A, Casani AP, Manfrin M, Guidetti G Abstract Benign paroxysmal positional vertigo (BPPV) is the most common type of peripheral vertigo. BPPV often relapses after the first episode, with a recurrence rate between 15% and 50%. To date both the aetiopathogenetic processes that lead to otoconia detachment and the factors that make BPPV a relapsing disease are still unclear, but recent epidemiological studies have shown a possible association with cardiovascular risk factors. The aim of the present study (Sesto Senso Survey) was to evaluate in the Italian population through an observational survey, the ...
Source: Acta Otorhinolaryngologica Italica - Category: ENT & OMF Tags: Acta Otorhinolaryngol Ital Source Type: research
Madeline shared her story on our Wheat Belly 10-Day Grain Detox private Facebook page. Her experience highlights many important aspects of this lifestyle, but especially how health can be transformed by sticking to this lifestyle and not being confused by “gluten-free” foods, the misguided advice of doctors, and overcoming stress that is inevitable in everyone’s lives. Her reward? Magnificent transformation in her health and appearance, all achieved by rejecting conventional dietary advice. “I’m posting to show that not everyone looses at the same speed–don’t be discouraged. I l...
Source: Wheat Belly Blog - Category: Cardiology Authors: Tags: Wheat Belly Lifestyle asthma diabetes gluten grains skin rash Weight Loss Source Type: blogs
In the three minutes it takes to read this blog post, an average of twenty-one people will turn age sixty-five, joining the largest cohort of older adults that our country has ever known. The simple truth is that we are living and working longer, which also means that we are redefining the meaning of “later life” and that older people are enriching our communities and society in new and vital ways. But many of us won’t enjoy a gentle retirement. Older adults are arguably the fastest growing subset of what are increasingly called “complex” patients—those with significant health and social...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending GrantWatch Organization and Delivery Quality Source Type: blogs
Laryngo-Rhino-Otol 2017; 96: 47-59 DOI: 10.1055/s-0042-119419Tinnitus ist ein Phantomgeräusch, das ein Symptom verschiedener Störungen sein kann, z. B. durch Hörverlust, kardiovaskuläre oder neurologische Erkrankungen, Diabetes oder Tumoren. Bei dekompensiertem Tinnitus leiden die Patienten aufgrund ihrer Unfähigkeit, die auditive Aufmerksamkeit vom Tinnitus-Ton abzulenken, an Schlaflosigkeit, Konzentrationsproblemen und anderen psychologischen Störungen. In extremen Fällen kann es zu Symptomen einer manifesten Depression kommen. Der auditorische Charakter des Tinnitus veranlasst d...
Source: Laryngo- Rhino- Otologie - Category: ENT & OMF Authors: Tags: CME-Fortbildung Source Type: research
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