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Manufacturers News

doi: 10.1097/01.HJ.0000525535.86925.aa
Manufacturers News

Manufacturers News covers the latest products, programs, and news from hearing health care companies. News releases and photographs are welcome. Please submit information to HJ@wolterskluwer.com.

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RAYOVAC GETS THE GREEN LIGHT FROM HEALTH CANADA

Battery manufacturer Rayovac (http://www.rayovac.com/) has obtained a medical device license (MDL), comparable to the U.S. Food and Drug Administration's 510(k), for its zinc air hearing aid batteries from Health Canada. The company said its quality system has been IOS-certified since the 1990s, and its batteries have already met most of the requirements for the MDL. Any changes made were focused on labeling and enhanced documentation processes. Health Canada, the country's department for national public health, considers batteries medical devices “when they are designed, manufactured, and labelled specifically for use with medical devices.” Hearing aids and hearing aid batteries are Class II medical devices, which means special licensing is required. To fulfill those requirements, hearing aid manufacturers must obtain an MDL from Health Canada.

Ann Rule, senior director of marketing at Spectrum Brands, Inc., which owns Rayovac, said complying with Health Canada's standards has a far-reaching impact. “All of our customers, regardless of market, will benefit from the processes we put into place to meet those requirements,” Rule said. “This accomplishment is another indication that Rayovac hearing aid batteries are always at the forefront of quality and safety.”

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COCHLEAR INTRODUCES FIRST MADE FOR IPHONE SOUND PROCESSOR

Cochlear (http://www.cochlear.com) now offers the Nucleus 7 Sound Processor, which the company says is the world's first and only Made for iPhone cochlear implant sound processor as well as the smallest and lightest behind-the-ear processor currently available in the market, after it was approved by the FDA in June. Nucleus 7 users can stream sound directly from their iPhone, iPad, and iPod touch to their sound processor. They will also be able to control, monitor, and customize their hearing on these devices through the Nucleus Smart App, which can be downloaded for free from the App Store. Through the new Hearing Tracker feature on the app, Nucleus 7 records the time when the sound processor coil does not detect the implant coil as well as time in speech, which is the amount of time spent in speech environments. Another app feature, Find My Processor, helps users locate a lost sound processor by using Location Services to determine the last place it was connected to its paired device.

Cochlear has also introduced the first Made for iPhone Smart Bimodal Solution, a system that consists of a hearing aid in one ear and a cochlear implant in the other and enables both instruments to provide synchronized streaming to both ears from an iPhone, iPad, and iPod touch.

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DECIBEL THERAPEUTICS GETS FUNDS TO EXPAND HEARING LOSS THERAPY RESEARCH

Decibel Therapeutics (https://decibeltx.com/) is receiving an equity investment and big data sciences and analytics support from GV, formerly Google Venture and is now the investment arm of Google's parent company, to expand its work in translating scientific advances in inner ear biology into novel therapies for people with hearing loss and tinnitus. Launched in 2015, Decibel is investigating the underlying biological causes of hearing disorders, and is developing a pipeline of therapies targeted at specific indications and populations. The company is collaborating with various organizations in the hearing space to assemble rich data sets comprising audiometric, genomic, and phenotypic data, said Decibel's chief data sciences officer John Keilty. “GV will not only help shape our overall strategy for big data analysis, but will provide technical guidance in a myriad of areas, including the use of cutting edge techniques to augment more traditional means of biological target identification.”

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ADVANCED BIONICS OBTAINS EXCLUSIVE PATENT LICENSE

Advanced Bionics (http://www.advancedbionics.com) has received two U.S. patents covering the measurement methods and apparatuses for using a cochlear implant electrode to create real-time electrocochleography assessments during or after cochlear implant surgery. One of the inventors of the techniques, Oliver Adunka, MD, said this technology will “have a significant impact on cochlear implantation because it has the potential to assess the details of electrode location, the neural substrate of the cochlea, and the level of intraocular damage in a real time fashion; and it applies to traditional cochlear implant candidates as well as to patients with residual hearing.”

This technique benefits not only those who are receiving the procedure but also those performing it. The other inventor, Craig Buchman, MD, said electrocochleography will be beneficial for cochlear implant surgery training and technique optimization because it provides immediate feedback about the state of the cochlea after surgery.

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