|IHS, ADA & AAA Send Letters to UnitedHealth & hi HealthInnovations
From The Hearing Review 11/4/11
Thanks to Bob MacPherson
Three of the major professional organizations involved in hearing aid dispensing responded last week with letters directed to hi HealthInnovations, a subsidiary of UnitedHealth Group that announced in early October its plans to market hearing devices via UH’s provider network and directly to consumers via the Internet. Both letters raised questions about the legality of the online marketing of hearing aids by hi HealthInnovations, as well as expressed concerns about eliminating hearing care professionals from the testing, selection, fitting, and rehabilitation process. (For more information, see the HR Online news item from October 3 and the October 10 HR interview of hi HealthInnovations CEO Lisa Tseng, MD, at www.hearingreview.com.)
In a “cease and desist” letter to Dr Tseng dated October 26, International Hearing Society (IHS) General Counsel John Paul Hessburg said that IHS believes hi HealthInnovations is not in compliance with FDA regulations in the company’s online marketing of hearing aids. Hessburg’s letter also states that they believe the company is in violation of most, if not all, state licensing laws.
The letter goes on to outline FDA requirements for dispensing hearing aids, including the provision of a User Instructional Brochure, labeling and warranty requirements, and steps to ensure that “red flag” medical conditions are identified prior to the dispensing of a hearing aid. “Based on our review of your website as well as our own participation in your online ‘hearing test,’ it is evident that your program requires the consumer to do their own ‘red flag’ testing. This ‘self diagnostic’ approach is not only inconsistent with the FDA's directives and State Licensing laws, it unreasonably places the consumer at great risk,” writes Hessburg.
Complete article: http://www.hearingreview.com/news/2011-11-04_02.asp