By David H. Kirkwood
hi HealthInnovations, which recently removed a controversial online hearing test from its web site after receiving a strong warning letter from the U.S. Food and Drug Administration (see our April 18 issue), hopes to resume offering that option to consumers soon.
So stated Will Shanley, the director of public relations for hi HealthInnovations’ parent company, UnitedHealthcare, in a brief e-mail response yesterday (April 24) to repeated inquiries from this blog. Shanley wrote, “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.”
Although the company says that it removed the online hearing test voluntarily, FDA’s letter suggests otherwise. In his letter of March 28, 2012, Steven Silverman, director of the Office of Compliance at FDA’s Center for Devices and Radiological Health, told the company’s CEO, Lisa Tseng, MD, that marketing its Online Hearing Test without marketing clearance or approval from the FDA was “a violation of the law.” He wrote, “Your firm should not continue to market the device until it receives FDA clearance” and warned that if it did so, “the FDA could initiate regulatory action, such as seizure, injunction, or civil money penalties against your firm.”
HOW THE LETTER GAINED ATTENTION
Neither the agency nor the company publicized the letter, and it was not until three weeks later that its existence became widely known.
It was the Academy of Doctors of Audiology (ADA) that first brought wider attention to the letter in an April 18 e-mail message to its members. The message contained a link to the FDA letter, which was posted on its web site.
ADA and the American Academy of Audiology (AAA) had both received a copy of the letter from a member, John Coverstone, AuD. He had obtained it from Josie Helmbrecht, AuD, who, as a member of the Speech-Language Pathologist and Audiologist Advisory Council to the Minnesota Department of Health (MDH), had received it from Catherine Dittberner Lloyd, a staff person in the Health Occupations Program of MDH.
In an interview yesterday with Hearinghealthmatters.org, Lloyd said that MDH has received questions over the last several years regarding online hearing aids sales and, more recently, online hearing tests. In fact, the MDH issued a news release last October advising consumers to be cautious about buying hearing aids over the Internet and urging those who suspect they have a hearing loss to see a hearing professional. The news release also noted that state and federal laws require that a qualified practitioner inspect a consumer’s ears before hearing aids can be sold to the consumer.
MDH has had ongoing communications with the FDA as part of a long working relationship and contacts on a number of regulatory issues, including and, in particular, the matter of Internet dispensing of hearing instruments.
As a follow up on this issue, Lloyd sent a Freedom of Information request to the FDA asking if it had any new information relevant to the issue of online sale of hearing aids. The federal agency responded by sending Lloyd a copy of its warning letter to Tseng, which was a public document, albeit a little known one.
FDA ACTION HAILED
Ever since hi Hearing Innovations announced last summer that it planned to sell hearing aids directly to consumers, using an online hearing test to program the instruments to the buyer’s hearing loss, all the major professional associations in hearing care, as well as the Better Hearing Institute, state health agencies in Minnesota and Arizona, and major hearing aid manufacturers have adamantly opposed the plan.
They insist that the evaluation and counseling of patients and the successful fitting of hearing aids require the face-to-face involvement of a qualified hearing professional. In its statement, the Better Hearing Institute, a non-profit educational foundation funded by the hearing industry, warned of “the inherent risks associated with purchasing over-the-counter, one-size-fits-all hearing aids instead of consulting a hearing healthcare professional.”
Critics also contended that in selling hearing aids to consumers directly and using an online hearing test, hi HealthInnovations was violating FDA regulations.
Therefore, when word of FDA’s letter became better known, the professional associations were quick to celebrate it—and also to take credit for their role in spurring the agency to act.
In a message to its members, AAA noted that it had begun discussing the hi HealthInnovations issue with the FDA in early November 2011 “and was instrumental in the Agency’s investigation of this matter.”
Therese Walden, AuD, the president, added, “The Academy is pleased to see that our multi-faceted approach to addressing the patient safety concerns associated with the hi HealthInnovations online hearing test and online hearing aid purchase continues to be effective. We will persist in our efforts on all fronts to ensure our patients receive the highest quality of hearing health care.”
In his letter bringing the attention of members to the FDA letter, Eric Hagberg, AuD, president of ADA, shared the credit. He noted, “ADA and many other national and state organizations have sent letters to the FDA regarding this issue, and we are pleased to see the FDA investigating those concerns diligently.”
Hagberg added, “ADA will continue to take aggressive action to ensure that our patients and consumers everywhere receive safe and effective hearing healthcare services, and we encourage you to do the same.”
However, it was not only the audiology organizations that pressed their case with the FDA. John Paul Hessburg, a principal in the International Hearing Society’s legal counsel, Kitch Drutchas Wagner Valitutti & Sherbrook, sent a five-page letter to the FDA on March 12. In it, Hessburg offered a detailed analysis of the legal issues, then concluded:
“Based on these various deficiencies in the apparent method of marketing, selling, and dispensing hearing aid devices by Healthlnnovations, IHS asks that you take action to further review and investigate these techniques and actions for the benefit and protection of hearing-impaired patients and consumers.”
The letter is posted online.