Vancouver, Wash.—April 19, 2012—
The Academy of Doctors of Audiology (ADA) and the American Academy of Audiology (AAA) haveconfirmed that the U.S. Food and Drug Administration has sent a letter to hi HealthInnovations’ CEO Dr. Lisa Tseng advising her that the company’s Online Hearing Test does not comply with FDA regulations. The company’s online hearing test is, according to the regulatory agency, a diagnostic device. To ensure safety and efficacy, such devices require clearance from the FDA before they are offered to the public, which the company has failed to obtain.
Audigy Group supports the Academies and other national and state organizations that have raised concerns about online hearing tests with the FDA. As an organization focused on delivering superior hearing care services,Audigy Group applauds the FDA in its decision. “Online tests fail to recognize the unique hearing needs of individual patients, and confiscatethe responsibility of Audiologists to diagnose potentially serious underlying medical conditions,” says Audigy Group CEO Brandon Dawson. “Patients deserve a higher standard,” he explains, “and an opportunity to achieve success in their pursuit of better hearing that online tests simply cannot provide.”
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