When hi HealthInnovations, a subsidiary of United Healthcare (UHC), announced in October 2011 it planned to offer direct sales of hearing aids to its beneficiaries, it sparked a firestorm of controversy. Many private-practicing audiologists viewed UHC's dispensing plan with skepticism and, in some cases, deep concern.
A number of audiologists objected to UHC's methodology—expressing concerns about the online "hearing test," the resulting lack of validation, and the lack of face-to-face contact with a certified, licensed audiologist—and signed petitions demanding a ban on Internet hearing testing and fitting of hearing aids. Most major hearing organizations, including ASHA, also expressed strong disapproval of certain aspects of UHC's program.
The organizations find a March 28 development encouraging: In a letter, the U.S. Food and Drug Administration (FDA) ordered hi HealthInnovations to cease marketing its "Online Hearing Test" until it submits a formal application to the agency and obtains premarket approval.
UHC's "Hearing Test" Protocol
In fact, the FDA had never determined that UHC's protocol—developed by audiologist Dianne Van Tasell and a team of audio engineers—resulted in the correct determination of the type and degree of a user's hearing loss. There was no control for background noise or calibration to ensure accuracy. Van Tasell stated that the purpose of that test was not to establish thresholds across frequencies, but rather to identify candidacy and to program a hearing aid (Van Tasell, 2012). But the needs of people with hearing loss were not well served by a procedure that wasn't proven to test hearing reliably and with validity.
Audiologists administer various tests—required by most states—to aid in the diagnosis of hearing loss, utilizing calibrated equipment and sound-treated rooms to ensure accurate results. During intake, an audiologist examines the ear, asks numerous questions, and runs a variety of standardized, scientifically validated tests that have been proven to determine the presence of hearing loss.
But UHC's "hearing test" was troubling because it did not always require a certified, licensed professional to examine the patient and, using the procedures noted, assess candidacy for amplification before hearing aids were provided. As Mark Ross, professor emeritus of the University of Connecticut, recently wrote, it is nearly impossible to complete a hearing test accurately without properly calibrated earphones and controlled acoustical conditions (Ross, 2012). It was clear to Ross that further research is desirable.
In its original form, the online testing protocol could not be used with bone conduction, tympanometry, speech testing, otoacoustic emissions, or other important tests. Nor could the ear be examined to determine whether cerumen impaction or perforations of the tympanic membrane might have been responsible for the hearing loss and required referral to a physician. To my knowledge, no audiologist has come forward in support of evaluating hearing in the absence of these tests and an ear exam. The FDA's order to remove the "test" only bolsters this stance.
A Lack of Validation
ASHA's Guidelines for Hearing Aid Fitting for Adults (1998) recommend a treatment protocol involving much more than the relatively simple, technical matter of fitting a hearing aid. Comprehensive hearing loss management requires an evidence-based, systematic approach that addresses not only the hearing impairment, but also co-occurring activity limitations, participation restrictions, and the resulting reductions in quality of life. Audiologists refer to outcomes measured in this way as "validation of treatment."
Although UHC's program, at the time of this writing, provides hearing aids only to people who can use open-fit devices and do not require a custom-made earmold—and only people with a mild to moderate hearing loss would be acceptable candidates for this benefit—validation of treatment is notably absent in some cases. There is sometimes no face-to-face contact with a certified hearing professional to administer tests, counsel the patient regarding appropriate expectations, or provide personalized fitting and follow-up care of the hearing device.
The FDA's letter to hi HealthInnovations states the company can continue its hearing aid sales, provided it complies with FDA regulations. But after hearing the concerns of national and state hearing-related organizations and individual audiologists, many state licensure boards also are reviewing UHC's plan. Some states—like New Jersey and Ohio—have voiced strong opposition to the plan based on their licensure and compliance guidelines. Colorado, Texas, and New York have previously banned Internet sales of hearing aids (and a Missouri ban was stricken by the 8th Circuit Court based on federal preemption).
On February 28, the Hearing Aid Advisory Council of Pennsylvania met with a representative of the Pennsylvania attorney general's office concerning online testing and Internet sales of hearing devices. The representative encouraged audiologists in Pennsylvania to contact the attorney general's office to express objections to the UHC program.
Each state attorney general's office must determine if the UHC plan violates that state's laws governing hearing aid sales, and take action to protect the state's citizens.
hi Healthinnovations' approach is new, but more important, it is untried. The health and safety of people with hearing loss depend on how well the dispensed hearing devices function. But studies have shown that successful hearing aid fittings are based not just on the audiogram, and that face-to-face evaluation and fitting of appropriate amplification by a certified professional is the requisite standard of care. All the major hearing health care organizations—including ASHA, the American Academy of Audiology, the Academy of Doctors of Audiology, the American Academy of Otolaryngology–Head and Neck Surgery, and the International Hearing Society—support this stand.