HR has just learned that on March 28, 2012, the US Food and Drug Administration (FDA) issued a 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.

The FDA letter was written by Steven D. Silverman, director of the Office of Compliance Center for Devices and Radiological Health, and addressed to hi HealthInnovation’s CEO, Lisa Tseng, MD,

On April 9, 2012, a little over a week after the date of the FDA letter, the American Speech Language Hearing Association (ASHA) reported that the online test had indeed been removed from hi HealthInnovation’s website. At that time, the company stated that the test had been removed for “enhancements,” and HR eventually received the same explanation from a company spokesperson.

News that the FDA had issued the letter was first reported in an April 18 e-mail alert from the American Academy of Audiology, which included a redacted copy of the letter that was sent to Dr Tseng.

The Academy wrote:

At Academy’s Urging, FDA Issues Cease and Desist Letter to hi HealthInnovations

Based on conversations between the American Academy of Audiology and the U.S. Food and Drug Administration (FDA), the FDA has issued a cease and desist letter with regard to the online hearing test offered by hi HealthInnovations. The Academy began discussions with the FDA in early November 2011 and was instrumental in the Agency’s investigation of this matter.

In the letter, which may be viewed here, the FDA asserts that hi HealthInnovations is in violation of the Federal Food, Drug, and Cosmetic Act, which requires marketing clearance or approval of devices by the FDA. The test is considered a device under the Act as its intended use is diagnostic in nature. The standards set forward in the Act are crafted to ensure patient safety as well as the efficacy of devices. The FDA has deemed hi HealthInnovations’ lack of adherence as a violation.

“The Academy is pleased to see that our multi-faceted approach to addressing the patient safety concerns associated with the hi HealthInnovations online hearing test and online hearing aid purchase continues to be effective,” said Academy President Therese Walden. “We will persist in our efforts on all fronts to ensure our patients receive the highest quality of hearing health care.”

In FDA’s letter, it explained its justification through the following:

Under section 201 (h) of the Act, 21 U.S.C. § 321 (h), the Online Hearing Test is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

A review of our records revealed that your firm has not obtained marketing approval or clearance before marketing the hi Healthlnnovations’ Online Hearing Test, which is a violation of the law.

The FDA letter later stated:

Your firm should immediately cease marketing the Online Hearing Test until your firm has submitted a new 510(k) application to be reviewed for clearance by FDA. You may continue to sell hearing aid devices provided you comply with the regulations found at 21 CFR 801.420 and 801.421.

Please notify this office in writing within thirty business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.

HR will be publishing this notice and more news in the upcoming May edition of Hearing Review. Check with HR‘s online news for more information as it develops.

Related Articles

UnitedHealth Enters Hearing Market: HR Interviews hi HealthInnovations CEO Lisa Tseng, MD
. October 11, 2011 HR Online News. Available at: /news/2011-10-11_01.asp

IHS, ADA and AAA Send Letters to UnitedHealth and hi HealthInnovations. November 4, 2011 HR Online News. Available at: /news/2011-11-04_02.asp

HLAA Publishes Statement on United HealthCare and hi HealthInnovations. March 22, 2012 HR Online News. Available at:  /news/2012-03-22_01.asp