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Breaking News: FDA Shuts Down hi HealthInnovations' Online Hearing Test

Shaw, Gina

doi: 10.1097/01.HJ.0000415182.80666.63


Hi HealthInnovations has removed its online hearing test from its website after receiving a cease-and-desist letter from the Food and Drug Administration March 28. (See FastLinks.) The company, an affiliate of insurance behemoth UnitedHealth Group, made a controversial entry into the hearing aid market last fall when it offered direct-to-consumer hearing aids at sharply discounted prices with no out-of-pocket costs to some Medicare Advantage members. (HJ 2012;65[2]:30 [See FastLinks.])

Obtaining hearing aids without a consultation with a qualified professional, and using only a limited online screening tool for diagnosing and prescribing the aid, caused an uproar among hearing healthcare professionals. The American Academy of Audiology, the Academy of Doctors of Audiology, and the American Speech-Language-Hearing Association asked regulators to step in. The FDA took action after reviewing hi HealthInnovations' website.

“Based upon the technology and point of use, the FDA determined that the online hearing test required 510(k) clearance. hi HealthInnovations did not obtain 510(k) clearance prior to making the online hearing test available,” explained Steven D. Silverman, the director of the Office of Compliance Center for Devices and Radiological Health. “Removing the online hearing test is a positive step by the firm. The firm is actively working with the FDA to bring their product into compliance.”

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hi HealthInnovations replaced its online hearing test with a place for consumers to enter audiogram results obtained elsewhere. “Ask your physician for a hearing test,” it said, and suggests that consumers ask their doctor to call hi HealthInnovations for a hearing test kit. “In addition, hi HealthInnovations audiologists and hearing professionals provide free hearing testing in many US cities. If you've already been tested within the past year, enter your results to order custom programmed hearing aids.”

This is a step in the right direction, but still poses problems, experts said. “The audiogram that results from entering hearing test data obtained by a hearing professional is certainly a more reasonable and acceptable approach than the online hearing screen that had problems associated with it,” says Vic S. Gladstone, PhD, the chief staff officer for audiology at ASHA.

Figure. Vic

Figure. Vic

“But people must still use a current set of data accurately obtained from a qualified professional, and of course, the consumer must accurately input their data into the template. Hearing test data should not be solely relied upon to determine candidacy for a hearing aid.”

Gregory Frazer, PhD, the owner of Pacific Hearing and Balance Center in Los Angeles and an AuDNet board member, also said he remains skeptical. Dr. Frazer sent a 14-point list of concerns to UnitedHealth Group after hi HealthInnovations launched its website last fall explaining that audiogram results will only give a rough approximation of what is needed. “It is incrementally a little bit better, but you are only 20 percent of the way there. Eighty percent of getting a good hearing aid is based on the audiology professional fine-tuning the device to the wants and needs of the individual.”



Dr. Frazer also suggested that encouraging consumers to ask their doctor to order the hi HealthInnovations kit is a flawed model. People with mild or moderate to severe hearing loss were significantly more likely to discuss their hearing with their family doctor than going to an ENT, an audiologist, or a hearing instrument specialist, Dr. Frazer said, pointing to findings from MarkeTrak VIII. (See FastLinks.)

“But the fact is that most primary care providers are not properly trained to provide a diagnostic audiologic evaluation,” Dr. Frazer said. He also noted that primary care doctors should know when to refer a patient to an audiologist, an ENT, or both, instead of prescribing a hearing aid. “But hi HealthInnovations is trying to get doctors to do their test in the office, bill for it, and sign clearances to get a hearing aid, all bypassing the audiologist,” he added.

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The online test might not be gone for good. Dr. Frazer said he heard that hi HealthInnovations plans to bring it back, a suggestion that is backed by a statement given to The Hearing Journal by Lisa Tseng, MD, hi HealthInnovations' chief medical officer. “We remain committed to offering people affordable, effective ways of understanding and addressing their hearing health issues. We are in discussions with the FDA regarding the Online Hearing Test and have voluntarily removed this test from our website while we work with the agency. We hope to bring an online testing option back in the near future,” she said.

ASHA has had several conversations with Dr. Tseng and other representatives from hi HealthInnovations and UnitedHealth Group, Dr. Gladstone said. “We wanted them to label their online hearing test as a screening tool. In the health arena, the failure of a screen necessitates referral for follow-up procedures,” he said.

ASHA also wants the hi HealthInnovations model to incorporate audiologists. “We have heard from some of our members that they have been asked to become a provider within that network, sometimes at the request of their own patients whose health insurance happens to be provided by UnitedHealth Group,” Dr. Gladstone said. “This is an indication that hi Health is trying to engage audiologists in the process, but how that will work remains to be seen.”

He added that hearing healthcare professionals want United Healthcare expand its hearing health benefit to include the diagnostic and rehabilitative services of an audiologist. “We haven't yet seen any clear indication that they're willing to do that,” he said.

The issue has brought hearing healthcare organizations together, putting them all on the same page, Dr. Gladstone said. It also may serve as the canary in the coal mine for hearing healthcare. “We do need to look at this model and ask if this is an indication that perhaps the whole hearing health delivery system, including the delivery of hearing aids, will be different in the future from what it has been for so many years. What role will audiology play in making sure that any new models are meeting patients' needs and ensuring quality hearing healthcare?”

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HJ Quick Poll

Would you request a hearing kit from hi HealthInnovations? Vote in our quick poll on or tell us your opinion by writing to

In April's quick poll, “Do you itemize your fees by services and equipment?” two people responded yes, and eight people responded no.

© 2012 Lippincott Williams & Wilkins, Inc.