Month: April 2012

FDA Issues Letter to hi HealthInnovations

HR has just learned that on March 28, 2012, the US Food and Drug Administration (FDA) issued a cease and desist letter to hi HealthInnovations that stated that the company’s online hearing test was in violation of the Federal Food, Drug, and Cosmetic Act and FDA ordered the company to take down the test until it was approved under 510(k) clearance.

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United Health/hi HealthInnovations Pulls Online Test

The online hearing test developed by hi HealthInnovations and designed to prescribe amplification for the company’s hearing aids has been taken down for “enhancements”, according to the company, as originally reported online by the American Speech Language Hearing Association (ASHA). There is no mention about when the test will go back online, and hi HealthInnovations did not immediately respond to HR.

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