MINNETONKA, MN– UnitedHealth Group Inc. announced last week that its direct-to-consumer offering of less expensive hearing aids has been extended to 26 million people covered by employer-sponsored and individual health insurance plans through UnitedHealthcare. The original program, unveiled 11 months ago, made the discounted hearing aids available only to people in Medicare-based plans.
The hearing aids, which are priced as low as $479 apiece for UnitedHealthcare participants, are being provided through a collaboration between UnitedHealthcare and hi HealthInnovations, sister companies in the UnitedHealth Group. Retail consumers can pay from $749 to $949 for the devices, which are manufactured by IntriCon Corp. of Arden Hills, MN.
UnitedHealthcare is the nation’s largest health insurance company in terms of membership
Sam Ho, MD, the company’s chief medical officer, said, “Cost is a significant barrier for millions of Americans suffering from hearing loss, and this new discount will help make hearing aids more accessible and affordable for more people nationwide.”
Last October, when UnitedHealth announced its plans to sell lower-price hearing aids directly to consumers, it set off a storm of protest from audiologists and hearing instrument specialists. They warned that allowing hearing aid purchasers to bypass the licensed hearing professional violated the Food and Drug Administration (FDA) hearing aid rule and would lead to poorly fitted hearing aids. They also warned that if consumers were not seen by a healthcare professional, any medical conditions that underlie their hearing loss might go undiscovered.
The Better Hearing Institute, the consumer education wing of the Hearing Industries Association, issued a warning to consumers last fall against what it termed “do-it-yourself hearing care.” It pointed to “the inherent risks associated with purchasing over-the-counter, one-size-fits-all hearing aids instead of consulting a hearing healthcare professional.”
ONLINE TESTING CHALLENGED
When it first began offering the UnitedHealth hearing aids, hi HealthInnovations also introduced an online hearing test that consumers could take at home on their computer so that the devices could be programmed to their individual hearing loss.
Although hearing professionals challenged the validity of the online testing, hi HealthInnovations continued to promote it. However, on March 28, the FDA advised Lisa Tseng, MD, CEO of Hi HealthInnovations, that the online test was being marketed without necessary approval from the agency. The warning letter said, “Your firm should not continue to market the device [i.e., the online test] 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 company quit offering the online test at least temporarily. In April, Will Shanley, the director of public relations for UnitedHealthcare, said in a response to Hearing News Watch, “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 web site while we work with the agency. We hope to bring an online testing option back in the near future.”
To date, the online test has not been revived. Now, the company advises consumers to get tested through one of the company’s hearing professionals or another healthcare provider.
The company is continuing to sell its devices directly to consumers, rather than selling them through hearing professionals, as the major hearing aid manufacturers do.