By David H. Kirkwood
SILVER SPRING, MD–The Food and Drug Administration (FDA) has thrown a monkey wrench into hi HealthInnovations’ controversial new online program to test consumers’ hearing and sell them custom-fitted hearing aids without any involvement by licensed hearing healthcare professionals.
In a letter dated March 28, 2012, Steven Silverman, director of the Office of Compliance at FDA’s Center for Devices and Radiological Health, advised Lisa Tseng, MD, CEO of Hi HealthInnovations, that his agency “has learned that your firm is marketing the hi HealthInnovations Online Hearing Test in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).”
Noting that the online test qualifies as a medical device under the Act, Silverman continued, “Your firm should not continue to market the device until it receives FDA clearance… Continuing to market an unapproved device violates the Act…and the FDA could initiate regulatory action, such as seizure, injunction, or civil money penalties against your firm.”
The FDA official told Tseng, “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.” However, he added, “You may continue to sell hearing aid devices provided you comply with [the pertinent] regulations.
The FDA directed hi HealthInnovations, which is owned by the giant health insurer United HealthCare, to reply to it within 30 days, describing the steps it has taken “to correct the noted violations” and explain what it will do to prevent any future violations.
The full FDA warning letter is available on the Academy of Doctors of Audiology web site.
ONLINE TEST NO LONGER OFFERED
Soon after the FDA warning, the company removed all mention of an online hearing test from its web site.
Now, the site tells visitors to get their hearing tested either by their physician or by an audiologist or other hearing professional. The company notes that it has sent its hearing test kit to many physicians and also that “hi HealthInnovations audiologists and hearing professionals provide free hearing testing in many cities.”
The site also advises consumers that if they have already been tested within the past year, they can submit their results online to order “custom programmed hearing aids.”
Last summer, when hi HealthInnovations announced its plans for a direct-to-consumer hearing aid marketing plan, all the major professional associations in hearing care strongly criticized it. They predicted that consumers who obtained hearing aids without being tested, advised, and counseled by a qualified hearing professional would be likely to be ill-served.
The Better Hearing Institute also opposed the approach. It issued a statement warning consumers of “the inherent risks associated with purchasing over-the-counter, one-size-fits-all hearing aids instead of consulting a hearing healthcare professional.”
Critics also contended that the online approach violated FDA regulations, a claim that seems to have been confirmed.
The company argued that its hearing aid program was aimed at the large number of people with hearing loss who refuse to go to a hearing professional for help. By offering consumers a quick and easy online testing and ordering process and charging less than $1000 per hearing aid, hi HealthInnovations said that it would reach people in need of help who would otherwise not receive it.
However, if the FDA fails to approve an online hearing test, that may undermine a stated advantage of the hi HealthInnovations approach, namely that it offers people a hassle-free way to get hearing aids programmed for their particular hearing loss.
NO RESPONSE FROM THE COMPANY
At the time this post was published, hi HealthInnovations had failed to respond to several calls and e-mails asking for a comment on the FDA warning letter and how it will affect the company’s plans.