On January 1, 2012, hi HealthInnovations, a subsidiary of UnitedHealthcare Group (UHG), introduced a new hearing health benefit to its members and non-members. This benefit includes direct-to-consumer marketing with the option to purchase hearing aid devices online. It is being offered to UHG's Medicare Advantage plan enrollees at a discounted rate of $749 to $949 per hearing aid.
The concept of selling hearing aids over the Internet is not new. However, the collaboration between hi HealthInnovations and UHG is the first model to provide this service as an insurance benefit.
While consumers have direct access to hearing aids through the online platform, hi HealthInnovations is contracting with hearing health professionals (audiologists and hearing instrument specialists) to evaluate patients and offer additional support. Audiologists should be aware that products sold by hi HealthInnovations and programming software are only accessible to hearing health professionals, including audiologists, who are contracted participants in the program, payment for services must be the contracted amount. Hi HealthInnovations will facilitate access to the hearing aid programming software and equipment for contracting audiologists.
More companies like hi HealthInnovations are engaging in direct-to-consumer hearing sales and over-the-counter hearing sales. As the term implies, sales are made directly to the consumer - in most cases without consultation with a hearing professional. Hi HealthInnovations's model is based on direct-to-consumer marketing and purchasing of hearing devices online as determined by the results of an automated process taken in a primary care physician's office, a test administered by one of the company's hearing professionals, or taken audiometric test results provided by the customer within the last year. The automated test does not require a health care provider who is trained in administering hearing tests to adjust the computerized test parameters. In addition, there have been no literature, studies, or findings discussed by hi HealthInnovations pertaining to the validity, accuracy, or legitimacy of the automated test administered in a physician's office.
In March 2012, ASHA submitted a letter to CMS raising concerns about the improper billing of CPT code 92552 related to hiHealthInnovation’s automated hearing test performed in primary care offices. CPT code 92552 is a diagnostic code that requires the skills of an audiologist; the hiHealthInnovations primary care test kit does not meet the Medicare standard, due to the application of automated technology. CMS verbally acknowledged our concerns.
ASHA raised concerns directly with hi HealthInnovations in 2012 regarding the test validity of the online and physician office hearing assessments, patient safety, and the direct-to-consumer model of hearing aid dispensing. The FDA later requested that the online hearing test be removed.
Though there have been some modifications to the hi HealthInnovations model, ASHA continues to have concerns regarding:
The Food and Drug Administration (FDA) regulates hearing aids in the United States as medical devices, as stated under Section 201 of the Federal Food, Drug, and Cosmetic Act, 21 C.F.R. Sec. 801.420. FDA regulations require that hearing aids, in the absence of a suitable waiver, not be distributed or dispensed without an examination by a medical doctor, as stated in the Act under Section 21 C.F.R. Sec. 801.421(a). The FDA defines a hearing aid as a wearable sound-amplifying device intended to compensate for impaired hearing. Hearing aids are subject to different types of premarket review requirements. Potential users of hearing aids (over the age of 18) must be advised that it is in their best interest to see a physician prior to purchase, or they must sign a waiver to indicate that they are explicitly declining this suggestion.
In addition, under Section 201 (h) of the Act, 21 U.S. Sec. 321(h), online hearing tests are also considered devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.
A personal sound amplification product (PSAP), on the other hand, is defined by FDA guidelines as a "wearable electronic product not intended to compensate for impaired hearing." It is designed to be used by non-hearing impaired consumers to amplify sounds related to various recreational activities (e.g., hunting, bird watching, lecture listening). A PSAP is not subject to FDA hearing aid device regulations. Hi HealthInnovations carefully describes the apparatus it is selling on its website as a hearing device, rather than a hearing aid. The FDA has issued guidelines pertaining to PSAPs in 2009 that are non-binding and instructional in nature. ASHA supports more binding and effective regulation of PSAPs.
ASHA encourages audiologists who have questions about hi HealthInnovations products or services or who encounter hi HealthInnovations beneficiaries seeking assistance with their hearing aids to contact Jennifer Stalpes, vice president of business strategy and development at hi HealthInnovations, at firstname.lastname@example.org.
Members who have information to share about their experience with consumers who have complained, or addressed concerns, about hi HealthInnovations products and hearing services, may contact:
If you have questions for ASHA about this issue, please send an e-mail to email@example.com.