A subsidiary of UnitedHealth Group has launched an online hearing test and a line of lower-cost hearing devices that are generating alarm about patient safety among otolaryngologists.
In an Oct. 2011 release announcing its products, hi HealthInnovations said its goal is to reduce the cost of hearing aids so that more people have access to them. About 36 million American adults have hearing loss, but only one of five people who could benefit from hearing aids wears one, according to the National Institute on Deafness and Other Communication Disorders.
Anyone can take the hearing test at hi HealthInnovations’ website, using earphones and most computers, tablets or smartphones. After completing the test, users are shown a summary of their “hearing health” and, if applicable, hearing devices that may work well for them. People who have had a hearing test within the past year can enter their audiogram results into the computer to see device recommendations. The website states that if consumers decide to purchase any of hi HealthInnovations’ four hearing devices, their test results will allow the company to custom program the devices to their specific hearing levels.
Hi HealthInnovations has contracted with several UnitedHealthcare Medicare Advantage and Medicare Part D plans to make the devices available to plan members. Some Medicare Advantage plan members would have no out-of-pocket costs. Retail consumers would pay between $749 and $949 for the hearing aids, much less than the usual cost.
Poor Results
Otolaryngologists worry about the accuracy and safety of the direct-to-consumer approach.
“There’s a reason that we have an audio booth that costs anywhere from $30,000 to $40,000 to do hearing tests, and that’s to maintain the accuracy of the hearing tests,” said Todd Hillman, MD, an otolaryngologist at Pittsburgh Ear Associates. “There is not a viable way to do an online hearing test that is accurate or consistent at this point in time.”
The hi HealthInnovations website tells consumers to take the test in a quiet place where there is no noise from the TV, fans or appliances. But these precautions are insufficient, otolaryngologists said. Everyone’s home has some background noise, which will affect the test results, Dr. Hillman said. That’s why a soundproof booth is necessary.
Audiometers are calibrated to meet federal guidelines, noted Mark Pyle, MD, academic vice chairman of otolaryngology and residency program director at the University of Wisconsin in Madison. This ensures test accuracy nationwide. With an online test, “there is no calibration, there is no soundproof room, there is no masking, there is no control,” Dr. Pyle said. “So we really don’t know what degree of hearing loss they have. Some people may receive devices that are too powerful. They may receive devices that aren’t appropriate.”
Results for a consumer who takes the test with background noise could show hearing loss where there is none, causing the person to buy a hearing aid that isn’t needed.
In addition, headphone quality is not standardized, Dr. Pyle noted. A person with low-quality or malfunctioning headphones could get test results indicating hearing loss that doesn’t exist.
The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) recommends that if patients suspect they have hearing loss, they should visit a physician who can refer them to an otolaryngologist. After a medical exam, the otolaryngologist then helps patients obtain an assessment from an audiologist. “The AAO-HNS strongly believes a physician-led hearing health care team with coordination of services is the best approach for providing the highest quality to patients,” the Academy said in an Oct. 13, 2011 written statement.
The physician-led approach was backed as the preferable model by Consumer Reports in a July 2009 article, the academy noted.
Hi HealthInnovations’ online test directs people to see a physician if their hearing loss is only on one side or occurred suddenly. But that recommendation is not enough, otolaryngologists said.
“There will be missed pathology that could potentially be life-threatening in the case of a vestibular schwannoma or skull-based tumor, and easily fixable problems that could be missed,” Dr. Pyle said. “A lot of these patients might have correctible problems that would be covered by insurance.”
Also, there is no guarantee that patients would visit a doctor if their online test results warranted it. Elderly patients, in particular, could think the process is streamlined and smart without realizing that a correctible or medically risky condition could be the cause of their hearing loss, Dr. Pyle said.
The U.S. Food and Drug Administration prohibits hearing aid sales unless the buyer has first received a physician’s evaluation, but consumers can waive that step if they’re older than 18.
Otolaryngologists expressed concern that under the direct-to-consumer model, people risk buying poorly fitting hearing aids and won’t get needed follow-up care. In its statement, the AAO-HNS noted that “mail-order hearing aids typically cannot be custom fit either in terms of physical fit or to compensate for the patient’s individual loss.”
Substantial numbers of patients need follow-up from an audiologist to make sure the devices fit properly and the electronic settings are right, Dr. Pyle said. He questioned how these needs could be met at a distance.
Although some hearing aids don’t require molding, many do need acoustic molds that are custom-made by an audiologist under direct visualization with hearing mold material, Dr. Hillman said. He’s heard of direct-to-consumer mold kits but doubts that patients can properly fit their hearing aids on their own.
The American Speech-Language-Hearing Association (ASHA) has stressed to hi HealthInnovations the key role of audiologists in any process that involves the fitting and dispensing of hearing aids, ASHA spokesman Doug Plesh said in an e-mail to ENT Today. The association also discussed with company officials the need for a controlled listening environment when conducting hearing testing.
Primary Care Role
In its press release, hi HealthInnovations stated that it will seek to engage more primary care physicians in the care of hearing loss, because early detection and treatment often lead to better outcomes. Test kits will be made available to primary care doctors, “providing them an additional tool to screen their patients for hearing loss,” the statement said.
Involving more primary care physicians in screening and diagnosing hearing loss is a fine goal, as long as they’re using proper equipment and the next step is referring patients with hearing loss to an otolaryngologist for an examination and making sure they get an accurate audiogram, Dr. Hillman said. “If they’re skipping steps and they’re using a screening test as an accurate audiogram, that’s what can lead to misdiagnosis and inaccurate fitting of hearing instruments,” he added.
Most primary care doctors are able to conduct a good exam of the ear and rule out problems such as an acute infection, a hole in the eardrum or a wax obstruction, Dr. Pyle said. But they might not be aware of all of the conditions for which they should refer patients to an otolaryngologist.
“A lot of these patients might have correctible problems that would be covered by insurance.”—Mark Pyle, MD
Cost Concerns
The AAO-HNS noted that Congress and many state legislatures are exploring “more acceptable ways to reduce the cost of hearing aids for consumers.” These ideas include tax deductions, tax credits and greater health plan coverage. United could increase its health plan coverage for hearing devices and reduce plan participants’ out-of-pocket costs, the Academy added.
United did not return calls for comment.
Although United is trying to find a lower-cost way to help people buy hearing aids, this should not be done at the expense of safety, Dr. Pyle said.
United’s effort is “the equivalent of someone with vision loss doing an online vision test, making a diagnosis themselves and ordering their glasses,” Dr. Hillman said. “What if they had glaucoma? What if they had macular degeneration? What if they had diabetic retinopathy? The vision test may come out the same as someone with normal vision loss. There is a reason why people getting glasses are not able to do it online. The same should hold true for hearing aids.”