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Effect of Noise Exposure on Human Auditory Function: Hidden Versus Not-So-Hidden Hearing Loss
Published in Stavros Hatzopoulos, Andrea Ciorba, Mark Krumm, Advances in Audiology and Hearing Science, 2020
For those patients with no quantitative deficits, the outcome of a clinical appointment may be disappointing or frustrating if the patient perceives the issue related to their communication abilities to be unresolved. It is conceivable that some patients might choose to take advantage of over-the-counter personal sound amplification products (PSAPs) in an effort to improve word identification. Of course, such decisions might also be made prior to seeking audiological care based on self-diagnosis, not just after an appointment in which a hearing aid was deemed not to be clinically indicated or appropriate. One recent study documented speech recognition improvements in patients using PSAPs and hearing aids. The improvements achieved with some (but not all) tested PSAPs paralleled the improvements obtained with a hearing aid. However, the PSAP devices used in that study were programmed to fit participant hearing loss by an audiologist in a clinical setting (Reed et al., 2017); thus, these devices were not over-the-counter customer purchases, and were not used by individuals with normal hearing. Those participants, with diagnosed hearing loss, are different and distinct from individuals with clinically normal thresholds who are at risk for “hidden hearing loss,” or more accurately, the not-so-hidden hearing loss that is observed as a measured deficit on word recognition tasks.
Safety Monitoring and Analysis in Oncology Trials
Published in Satrajit Roychoudhury, Soumi Lahiri, Statistical Approaches in Oncology Clinical Development, 2018
Anastasia Ivanova, Qi Jiang, Olga Marchenko, Richard C. Zink
Safety evaluation is critical for drug development. To ensure systematic safety monitoring and evaluation, one needs a proactive safety evaluation that can be performed objectively and in a timely manner. Having the necessary safety-related documents, such as a risk management plan (RMP), can facilitate safety evaluation. However, the RMP does not consider any of the statistical aspects of development activities, so it must be complemented by a more focused document called a program-wide safety analysis plan (PSAP). The PSAP often contains the following sections: background, general plan, data generation, fata structure and content, methods for analysis, presentation and reporting, and problem-oriented summary for AEs of special interest (AESIs). A PSAP has been recommended by the Safety Planning, Evaluation and Reporting Team (Crowe et al. 2009), but it is currently not required by regulatory agencies. Nevertheless, several sponsors have adopted and implemented a PSAP (or a similar document by a different name) for documenting the appropriate data to be collected and the analyses to be performed in order to characterize the safety profile of the new therapy throughout the development life cycle. As added benefits, the PSAP can facilitate ongoing interactions with regulatory agencies regarding current safety strategies and can aid in the evaluation of the BR profile of the new therapy in the post-marketing stage.
Consensus on connected hearing health technologies and service delivery models in the UK: a Delphi review
Published in International Journal of Audiology, 2022
Anne Olson, David W. Maidment, Melanie A. Ferguson
Numerous types of technologies for hearing loss have become commercially available in the last decade and may offer more affordable and accessible approaches to address hearing loss. While several terms are used interchangeably in the literature, and there is no consensus concerning terminology, we will use the term connected hearing health technologies (CHHT) hereafter to specifically refer to amplification devices that can connect wirelessly, either directly or indirectly, to smartphone technologies, as well as other remote technologies. CHHT have some similar characteristics and functionality to conventional hearing aids, yet there remain distinct differences, such as in terms of current regulation and customisation (either by the user or remotely by an audiologist). CHHT can include smartphone-connected hearing aids, personal sound amplification products (PSAPs), hearables, smartphone applications (or apps), and over-the-counter (OTC) hearing aids. A selection of CHHT and their respective features are summarised in Table 1. For example, PSAPs were originally intended for persons without hearing loss to amplify sounds in recreational environments and, thus, do not require an individual to consult a hearing healthcare provider (HHCP). For this reason, in the United States (US), PSAPs cannot be marketed as devices that help individuals overcome hearing loss.
Subclinical atherosclerotic predictive value of inflammatory markers in thalassemia intermedia patients
Published in Expert Review of Hematology, 2021
Osama Ahmad Ibrahim, Ahmad B. Ahmad, Dalia Ahmad Nigm, Asmaa Nady Hussien, Walaa H. Mohammad Ibrahim
The studied group of patients was found to have lower LVSEF compared to controls which was in concordance with the findings of Adly study [29]. Cardiac toxicity is often insidious; less than half of the patients with β-thalassemia have detectable cardiac iron, though many of them are asymptomatic [73,74]. Electrocardiography and echocardiography signs of iron toxicity do not appear until severe cardiac iron deposition has occurred [75,76]. Cardiac iron overload is the leading cause of death in patients with TM and TI, which is associated with cardiac dysfunction and chronic cardiac failure [77,78]. Higher PSAP, which is found in our patients, was in agreement with Moghaddam and Amoozgar studies [79,80]. Endothelial activation along with chronic inflammation underlies the pathophysiology of B-thalassemia [56]. This endothelial dysfunction is characterized by reduced nitric oxide bioavailability, and pro-oxidant and pro-inflammatory stress [81]. As a consequence, blood cells adhere and migrate through the endothelium into the tissues [82,83], with the development of vascular intimal hyperplasia, platelet activation, neutrophil adhesiveness [57,84], and coagulopathy, resulting in further vasomotor instability, proliferative vasculopathy, and endothelial injury [57,84], a hallmark of the development of pulmonary hypertension (PHT) in adulthood [81].
A systematic review and meta-analysis assessing the effectiveness of alternative listening devices to conventional hearing aids in adults with hearing loss
Published in International Journal of Audiology, 2018
David W. Maidment, Alexander B. Barker, Jun Xia, Melanie A. Ferguson
Existing evidence is mixed in terms of whether alternative listening devices are a suitable management strategy for hearing loss. For example, ‘mid-range’ (US$100–$500) personal sound amplification products (PSAPs), a type of ‘direct-to-consumer’ hearing device, have been shown to provide comparable electroacoustic characteristics (i.e. meet gain and output targets using National Acoustic Laboratories prescriptive procedures) to hearing aids (Callaway and Punch 2008). By comparison, other products defined as ‘low-cost’ (<US$100) may be of limited benefit and potentially damaging to residual hearing due to over-amplification (Callaway and Punch 2008; Chan and McPherson 2015). Smartphone-based ‘hearing aid’ apps have also been shown to provide similar levels of amplification, improved speech-in-noise performance and greater self-reported benefit in comparison to hearing aids (Amlani et al. 2013). Remote microphone systems have also been shown to improve hearing outcomes, but may require additional audiological support for optimal use (Boothroyd 2004).