April 18, 2012
Late yesterday ADA came into possession of a letter from Steven Silverman, Director of Office of Compliance, Center for Devices and Radiological Health at the U.S. Food and Drug Administration to Lisa Tseng, MD, CEO of Hi HealthInnovations. In the letter, dated March 28, 2012, the FDA outlines several areas where the HI online hearing test stands in violation of laws and regulations administered by the FDA. The letter further orders HI to cease marketing the online test immediately.
Please click here to view the letter in its entirety.
The HI online test has (again) been removed from its website, we assume at least in part as the result of the FDA letter. ADA will continue to monitor this situation and will provide additional updates as they become available. ADA and many other national and state organizations have sent letters to the FDA regarding this issue, and we are pleased to see the FDA investigating those concerns diligently.
ADA will continue to take aggressive action to ensure that our patients and consumers everywhere receive safe and effective hearing healthcare services, and we encourage you to do the same. If you are aware of other key constituents and authorities who should also be made aware of this letter, please feel free to forward this e-mail to them. The link to the letter will remain in a public area of the ADA website for easy access to download and distribute.
Thank you ADA members for your vigilance and persistence on this very important issue.
Eric Hagberg, Au.D.