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A Canadian medical device company, Clearwater Clinical, is aiming to address the challenges facing the hearing industry through the development of a new hearing test to help communities underserved by audiologists.
MedCityNews reports on the company’s approach following an interview with CEO Michael Weider. The company sees their tablet-based testing platform, called Shoebox, as a way to make hearing tests more accessible and portable. “We have really tapped into an unmet need. Shoebox has changed the whole interface of how hearing tests can be done by making it simple,” Weider explains.
Hearing tests are often done in booths to filter out ambient noise. Companies required to test employees in accordance with US Occupational Safety & Health Administration (OSHA) requirements often use a mobile testing facility equipped with a testing lab that is driven to the workplace for individual testing of workers. Weider believes current practices are antiquated and expensive.
The company’s solution is a validated iPad audiometer that, according to Clearwater Clinical, provides diagnostic threshold accuracy and power in a small mobile form. Shoebox simply uses an iPad and calibrated headphones, and complies with current regulatory requirements in North America. It can be used by primary care physicians, audiologists, and companies in industry that are required to test the hearing of their staff, but it is not intended for use directly by consumers. The testing solution uses a modified Hughson-Westlake protocol and is listed as a Class II medical device by the US FDA and Health Canada.
Source: MedCityNews; Clearwater Clinical
