SHOEBOX is world’s first CE Marked iPad-based Audiometer
Ottawa, ON, February 1, 2018 – Today, Clearwater Clinical Limited announced that the company has received CE Mark approval for SHOEBOX Audiometry in Europe as an audiometer intended for diagnosis of human hearing loss. SHOEBOX is the world’s first CE Marked iPad-based audiometer. The device is also listed as a Class II medical device with US FDA and Health Canada.
The CE Mark approval was based on rigorous clinical evaluation and demonstrated conformance to European harmonized standards in areas of health, safety, and environmental protection, and allows SHOEBOX to be used to perform clinical hearing testing in the European market.
“We are proud of this significant milestone,” said Michael Weider, CEO of Clearwater Clinical. “There has been growing demand for SHOEBOX outside of North America. The addition of the CE Mark to our long list of approvals, accreditations, and validations is vital to our planned expansion into the European market. It is also further evidence of our commitment to meeting the highest standards of quality and regulatory compliance as a medical device manufacturer.”
Comprised of SHOEBOX Audiometry software, an iPad, calibrated transducers and a cloud-based data management system, SHOEBOX is the easiest-to-use and most portable audiometric system available on the market today. Ideal for mobile clinicians, occupational hearing conservationists, clinical research, and more, SHOEBOX packs all the power of a traditional audiometer into a small, mobile form factor. The system offers a variety of flexible testing options, from self-testing to test administration by hearing health professionals.
In addition to securing CE Mark approval, and with a continued focus on ensuring that SHOEBOX is easy to use, all patient-facing screens of SHOEBOX Audiometry in automated mode are also now available in 27 different languages. Translations include:
- Portuguese (Portugal)
- Spanish (Spain)
About SHOEBOX Audiometry
SHOEBOX Audiometry is a division of Clearwater Clinical. Co-founded in 2005 by Dr. Matthew Bromwich, an ENT specialist, and led by CEO Mr. Michael Weider, Ottawa-based SHOEBOX Audiometry is leading the way in mobile hearing health. Our clinically validated iPad-based audiometer makes it possible to reliably measure hearing outside of a traditional sound booth. The device addresses a growing need in the market to test the hearing of more patients in more locations with less effort and increased efficiency.
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