Audiologists wage grassroots campaign against direct-to-consumer hearing aid sales

David Kirkwood
November 6, 2013


By David H. Kirkwood

When hi HealthInnovations announced two years ago that it would start selling “high-tech, lower cost hearing devices” directly to consumers, hearing healthcare organizations immediately denounced the plan. They contended that in bypassing the hearing professional, hi’s distribution model would provide inferior hearing solutions and would also endanger patients whose hearing loss was a symptom of an underlying medical condition that a licensed practitioner would be likely to detect.

Leading the opposition to hi HealthInnovations, a subsidiary of the managed healthcare giant United HealthCare (UHC), were the major national associations of hearing professionals, including the American Academy of Audiology (AAA), the International Hearing Society (IHS), the American Speech-Language-Hearing Association (ASHA), the Academy of Doctors of Audiology (ADA), and the Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS).

Joining them in condemning direct-to-consumer sales were the Better Hearing Institute, governmental agencies in several states, and numerous state affiliates of AAA and IHS.



Mark Caffrey

Mark Caffrey

More recently, individual practitioners have been joining a grassroots campaign to discourage their patients from getting their hearing aids through UHC’s direct-to-consumer system. A letter addressed to “all United Healthcare Patients” has been circulating by e-mail within the audiology community and is also posted on ADA Connect, the Listserv for members of the Academy of Doctors of Audiology.

The letter was composed by Mark Caffrey, AuD, owner of Caffrey & Associates Audiology.  Caffrey, who has offices in Gloversville and Amsterdam, NY, told Hearing News Watch that he wrote it specifically for his patients, and had no plan to disseminate it more broadly. He explained, “I was vehemently opposed to direct-to-consumer hearing aid sales and I wanted our patients to understand our concerns.” He noted that in composing the letter, he drew heavily on information provided by the American Academy of Audiology.

The letter begins, “This practice and the professional doctors of audiology and/or licensed audiologists who work here will not participate in any way with United Healthcare’s ‘Direct-To-Consumer Hearing Aid Benefit.’”

It continues, “The American Academy of Audiology, the American Speech & Hearing Association, the International Hearing Society, the federal Food and Drug Administration, and several state licensing boards have raised concerns about the significant risks and consumer safety issues with United Healthcare’s dispensing model. We believe that the consumer is not being fit responsibly or ethically via the United Healthcare ‘Direct-to-Consumer Hearing Aid Benefit.’”

Caffrey’s letter goes on to specify objections to direct-to-consumer distribution. Among these are:

• “Lack of professional intervention at any level (evaluation, diagnosis, referrals, medical contraindications, treatment options, on-going counseling/rehabilitation, education and on-going patient-focused care);

• “The assumption by the hi HealthInnovations team that the device was the ‘cure’;

• “The need to address conductive/mixed losses and other medically relevant issues such as asymmetry;

• “Issues related to dispensing a hearing aid without a license;

• “Lack of follow-up care.”

Caffrey, who began using the letter in his practice last January, said that many of the people who have come into his office for an audiological evaluation so they can order hearing aids from UHC “have respected my opinion” and decided to get their hearing aids from his practice. After reading the letter, they understand that if they buy hearing aids from the company they will not have a practitioner to turn to to have them fitted properly, modified, and serviced.

The letter, which also contains a detailed history of UHC’s direct-to-consumer program and the objections to it, gained national attention when he posted it on the ADA ListServ in response to a member seeking advice on what to tell patients about the program. Since then, more audiologists have begun using the letter, though there is no way of knowing how many.



hi Health Logo UHGI invited Will Shanley, a spokesperson for hi HealthInnovations, to comment on Caffrey’s letter and also asked him several questions about his company’s direct-to-consumer program. Shanley responded with a statement that, while not directly addressing the letter, did offer a defense of HI’s distribution model. He wrote, in part:

“HI HealthInnovations is dedicated to improving the access and affordability of hearing aids. Published studies show that 90% of people with hearing loss could benefit from hearing aids, but only 25% currently use them. Hearing health provider associations have acknowledged that the cost and traditional service delivery models for hearing aids have been “barriers to accessing hearing health care.”

Shanley added that his companyseeks to address those concerns by offering people additional access points to the hearing health system, including through a national staff of licensed audiologists and hearing health professionals who provide in-person testing, fitting and support… We believe consumers benefit from alternative hearing aid dispensing models that improve access and affordability, while helping ensure safety and quality.”

Asked how many hearing aids hi is selling via its direct-to-consumer model, Shanley declined to give numbers (hearing aid companies almost never reveal their sales figures). He did say that the company “is growing rapidly” and has staff audiologists or hearing health professionals in more than 35 states, with plans to expand to additional states during the next year.

The hi spokesman did not answer a question posed to him about whether hi hopes to obtain FDA approval to use an online hearing test rather than asking prospective hearing aid purchasers to submit an audiogram, as they do now. Originally, the company offered consumers an online test that made it possible for them to buy hearing aids without any contact with an audiologist or hearing aid specialist. However, in March 2012, the Food and Drug Administration advised the company that using its online hearing test without the agency’s approval violated the Federal Food, Drug, and Cosmetic Act.



HI HealthInnovations/UHC is only one of many companies selling products directly to consumers with hearing loss. However, it is by far the largest such company and also one of the few that is selling its products as hearing aids rather than personal sound amplification products (PSAPs), which generally escape governmental regulation.

These factors explain why individuals and organizations that are part of the traditional, regulated hearing aid distribution system have so strongly opposed this particular program. How effective their opposition will be remains to be seen.



  1. I am interested in knowing : What is HHTM position on this matter? Do you side with the dispencing groups or do you side with UHC?

    John Bart

    1. Dear John,

      Thank you for your question. The short answer is that HHTM has no opinion on this matter or on any other topic. HHTM is a collection of blogs with numerous editors with, I assume, varying opinions on everything except for our shared commitment to establishing HHTM as the leading publication on hearing health.

      My post, to which you are responding, is a news story, which is as accurate and objective as I could make it. I hope readers found it interesting and informative.

      While HHTM as a whole does not take sides on issues, we do have a blog, Hearing Views, that publishes informed opinions and perspectives every week on topics related to hearing. I am confident that my colleague Kevin Liebe, who is editor of that blog, would be open to publishing a Hearing View on the UHC issue if you or anyone else submits one.

      Again, thank you for your comment.

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