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Tuesday, March 12, 2019

In February 2019, Kansas Army veteran Kelby Rice filed a lawsuit against 3M, the manufacturer of the standard-issue Duel-Ended Combat Arms Earplugs Version 2 (CAEV2) earplugs that he and his comrades used during their enlistment. Rice's lawsuit against 3M claims the company knew its product was defective but continued to sell the earplugs to the United States Military for more than 10 years.

Rice used the CAEV2 earplugs regularly throughout his career, both while training at Fort Leonard Wood in Missouri and while stationed in Iraq. In early 2019, Rice started experiencing symptoms associated with tinnitus. Rice's lawsuit is just one of many now flooding U.S. courts,  months after the Department of Justice reached a $9.1 million settlement with 3M over the CAEV2 earplug defects in July of 2018.

With increasing reports of occupational hearing loss, especially among military veterans, audiologists play an important role in identifying hearing issues among veterans. In addition to more than 81,000 instances of hearing loss among first-time benefit recipients, the 2017 VA Benefits Report cited 159,800 cases of tinnitus. Plaintiffs in the CAEV2 lawsuits have reported symptoms of hearing damage, including tinnitus or ringing in the ears, issues with balance such as vertigo, and in extreme cases, severe or permanent hearing loss.

Military personnel may be asked to perform tasks that expose them to loud equipment or operating conditions that often exceeds what the Occupational Safety & Health Administration (OSHA) has deemed safe for civilian workplaces. OSHA's Hearing Conservation Program is designed to prevent hearing impairment and promote a safe working environment for civilian employees. Typical OSHA requirements limit employee exposure to sound exceeding a time-weighted average noise level of 85 decibels or higher over an eight-hour work shift.

By comparison, a soldier in the workplace or deployed in combat is likely to encounter between 103 dB and +180 dB, sometimes on a daily basis. Because of this, military personnel are issued protective equipment including but not limited to earplugs or earmuffs to protect their hearing against both constant and impulsive noises.

Hearing protection is essential in all workplaces. Furthermore, when it comes to education, it's important that military personnel, are informed and prepared for potential hearing complications in the future. Above all, these cases illuminate the need for strict standards and regulations when it comes to new product testing. The cost and potential gain when developing, designing, and releasing protective hearing devices should never take precedence over the safety of its users.

ABOUT THE AUTHOR: Joseph Oot is a consumer advocate specializing in consumer legal issues including current litigation surrounding dangerous, contaminated, or defective products. His work connects him with both local and national organizations, all centered on assisting consumers, researchers, and professionals alike.

Friday, March 8, 2019

CVS Health is shutting down its 50 audiology centers across the country in anticipation of the Over-the-Counter (OTC) Hearing Aid Act taking effect soon. The FDA is set to introduce regulations to allow OTC hearing aid sale next year, which will eliminate the need for CVS to dedicate store space for audiologists to conduct hearing tests and fit patients with devices. CVS spokeswoman Erin Pensa said the company made the decision to close the centers because the hearing care market has evolved since CVS started piloting audiology services in 2015 in a statement to Hearing Health & Technology Matters, which first broke the news. "As such, we are shifting our audiology strategy to better position CVS Pharmacy as a leader in offering clinically effective, lower priced hearing devices once the new over-the-counter category is approved by the FDA," she wrote. 

Friday, March 8, 2019

Grason-Stadler (GSI) has launched a new online education program called, GSI ADVANCE. This program offers educational opportunities for audiologists that cover a wide range of content and learning mediums centered around core audiologic topics including the latest technology.  

Untitled.pngGSI ADVANCE content is designed to suit all the needs of audiologists. The program is categorized into nine areas of focus to provide audiologists a clear, concise, and logical user experience. The areas of focus include live and recorded webinars, quick facts, reviews, ask the experts, training videos, downloadable educational content, and much more. In addition, there are several ways in which audiologists can receive CEU credits.  

All ADVANCE learning opportunities can be categorized into one of three levels of learning: Introductory, Intermediate, and Advanced. One of the three icons placed above will be displayed on each resource to quickly identify the direct complexity of the content. Sample course include GSI screening, maximizing the utility of acoustic refexes, automated hearing assessment, and more.  


Friday, March 8, 2019

Sivantos and Widex successfully completed a merger, forming the new WS Audiology. The merger has created a strong player with combined revenues of more than EUR 1.7 billion, over 10,000 employees, and one of the strongest R&D teams in the industry. Sivantos and Widex have a combined experience of more than 170 years in the more than 125 countries.

WS Audiology, with headquarters in Lynge, Denmark and Singapore, will be led by a management team with a balanced representation from both Sivantos and Widex. Jørgen Jensen, until now CEO of Widex, will head the new company as Chief Executive Officer. Before joining Widex in 2013, he spent 15 years at Nilfisk-Advance, the last eight of which as President and CEO. He previously worked for McKinsey.

Wolfgang Ollig, Sivantos' current CFO, will continue in the same position at the new company. Prior to joining Sivantos in 2016, he held the role of CFO at Hella, one of the world's leading automotive suppliers, for 10 years. Like Jørgen Jensen, he started his career at McKinsey.

Thomas Ebeling, Chairman of the Board of Directors of Sivantos, has been appointed Chairman of the Board of Directors of WS Audiology. Jan Tøpholm, up to now Chairman of Widex, will take on the role as Deputy Chairman. Ignacio Martinez, to date CEO of Sivantos, will join the Board of Directors, and Henrik Bender, until now CFO of Widex, will lead the integration process.

"Today marks the beginning of a great new journey. Two pioneers joining forces with one clear ambition: to expand access to hearing aids and care to serve the millions of people with hearing needs across the world. This merger gives WS Audiology the scale and innovation capabilities to deliver on this goal. We are setting out to excel with best-in-class products and accelerate our shared growth across all our brands. The future holds great opportunities and together, as one team, we will be able to seize the momentum we have gained," said Jensen, CEO of WS Audiology.

"Both Widex and Sivantos have been at the forefront of innovation in the industry. Together, WS Audiology has abundant resources to create excellent products and further accelerate innovation with creative, high-tech and easy-to-use products and services, broadening the choice for hearing aid users," said Ebeling, Chairman of the Board of Directors of WS Audiology.

"As WS Audiology takes shape today, we are one big step closer to becoming the clear innovation leader, developing the best possible hearing aids to improve the life of those with hearing needs. We are united by our proud heritage, our long history as 'first movers', and our insatiable curiosity that drives our innovation and technology," said Tøpholm, Deputy Chairman of the Board of Directors of WS Audiology.

WS Audiology will offer a diverse portfolio of technologically advanced hearing aid products and services, with its brands Signia, Widex, Rexton, Audio Service and others. Going forward, WS Audiology plans to accelerate its growth, strengthen its market penetration, and enhance efficiencies to enable additional investments in R&D and the supply chain. 

Tuesday, March 5, 2019

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ZPower is expanding its market focus after helping bring rechargeability to the mainstream market for hearing aids and launching innovative products in the medical and consumer electronics markets in 2018. ZPower’s growth in the previous year included two new facilities, doubled production floor space, and an additional $30M investment to meet the increasing market demand for miniaturized devices.

 “While the silver-zinc chemistry has been in use for decades with NASA and military applications, our dedicated research has advanced the technology, miniaturizing it without the loss of energy density and developing a patented charging method that enables hundreds of charge cycles without significant decline in performance,” said Ross Dueber, CEO of ZPower.
 
 “This breakthrough introduced small-scale rechargeable power in ways that weren’t previously possible while eliminating the safety and transportation concerns associated with lithium-ion technology,” he added. “It’s positioned ZPower as an innovator and enabler in advanced miniature power solutions.”
 
In support of this expansion, ZPower has also embarked on a brand evolution to better align with its expanded market focus. The company has already begun rolling out new brand assets and plans to launch a new website in early Q2 of 2019.
 
“We’re excited about the future and have great confidence in our ability to help bring innovative new products to life, as we continue to increase energy density in our micro batteries,” said Anson Martin, Chief Commercial Officer.
 
“Brands are meant to evolve, and our brand evolution will reflect our journey and what lies ahead,” Martin stressed. “It signifies our progression into a mature and professional organization that’s in line with the caliber of businesses we currently work with and our future customers.”