By David H. Kirkwood
For audiologists and other hearing healthcare providers, there’s been no more disturbing development in recent years than the explosion in the sale of hearing aids directly to consumer sales.
When hard-of-hearing consumers buy hearing aids without the care of a trained professional, practitioners lose out on the revenues they would have received if these consumers had come to them. Moreover, hearing professionals point out, people with hearing loss also lose out because they do not get hearing aids selected and programmed specifically for their particular needs, and they may even be putting their health at risk.
hi HealthInnovations, part of the giant UnitedHealth Group, is probably the best known of the companies that sell hearing aids without any in-person involvement by a hearing professional. But there are dozens of others companies selling devices to consumers online or through retail stores, generally for much lower prices than hearing aids obtained through traditional dispensing channels.
Many of these companies describe their wares as personal sound amplification products (PSAPs) to avoid being subject to the Food and Drug Administration (FDA) regulations for hearing aids. But their marketing makes clear that PSAPs, like hearing aids, are designed to help people with hearing loss.
Another company that has started to sell hearing aids online is General Hearing Instruments (GHI), which for most of its 27-year history distributed its products exclusively through licensed professionals.
According to Mike Major, production manager of the Louisiana-based company, GHI still sells most of its hearing aids that way. However, for some time its non-custom hearing aids have been available over the counter in hundreds of stores, mostly Walmarts and Sam’s Clubs. More recently, GHI began selling ReadyWear products online.
Major noted that these non-custom devices are intended to give people with mild to moderate hearing loss an easier and less expensive option than going to a professional for hearing help.
THE ACADEMY FIGHTS BACK
All the major professional organizations in hearing care, including the American Academy of Audiology (AAA), the International Hearing Society, the American Speech-Language-Hearing Association, and the Academy of Doctors of Audiology have taken steps, individually and together, to turn back the rising tide of online hearing aid sales.
The latest such effort was launched last week when AAA announced to members that it had posted toolkit on its web site to “provide you with the resources to educate consumers, receive fair compensation, and inform legislators about the dangers of removing the audiologist and audiological services from the hearing aid fitting process.”
The academy, which has more than 11,000 audiologist members, said, “The proliferation of direct-to-consumer hearing aid delivery models has presented challenges to the practice of audiology. This kit was designed to provide tools and resources to help you address this evolving service delivery model while maintaining a successful and vital practice where the audiologist remains central in the provision of hearing healthcare diagnosis and treatment practices.”
A growing problem
One section of the toolkit, entitled Managing Patients Who Have Purchased Hearing Aids Elsewhere, advises AAA members, “The success of online commerce has resulted in an increase in patients obtaining hearing aids through online venues. Obtaining a hearing aid online can be attractive to a consumer who is not well informed about the unpredictable complexities of an effective and individualized hearing aid fitting.”
It continues, “Many in the general public believe that the management of hearing loss is accomplished with a device alone. The average consumer of hearing care is not aware of the necessary components for successfully managing a hearing loss.” Among these it lists selecting and programming a device appropriately, extensive counseling, individual needs assessment, creating realistic expectations, and hearing aid maintenance.
Speaking to consumers
The kit has several sections suggesting arguments for members to use in explaining to patients why they need an audiologist to get a successful hearing aid fitting.
One passage states, “Hearing aids are medical devices regulated by the Food and Drug Administration (FDA) and must be recommended and prescribed by licensed professionals. This standard is in place to protect the individual with hearing loss, as not all individuals are candidates for amplification.
“Additionally, an improperly fit hearing aid or hearing aid sold online without a face-to-face evaluation with an audiologist can potentially cause various problems. Without a face-to-face evaluation, the consumer will not have an otoscopic evaluation (have the audiologist look into the ear canal) and medical problems such as ear drainage or ear blockages which can cause hearing loss will not be identified.
“Additionally, hearing aids that are not adjusted to the individual needs of the patient have the potential for increasing the hearing loss if the devices are not set appropriately. Lastly, audiologists can tailor a comprehensive treatment plan for each individual patient so as to ensure maximum performance from any device that may be prescribed.”
The kit casts a dim light on online hearing testing, an approach used by some companies that say they can sell customized hearing aids directly to consumers. A section on that topic states:
“While a hearing test completed in the convenience of your own home may be attractive as an alternative to making an appointment to see an audiologist, the tests and equipment currently available have never been approved by the FDA. The accuracy of online hearing testing for purposes of diagnosing a medical hearing loss is highly suspicious and unlikely to be accurate or reliably identify the extent of your hearing problems.”
The academy also discusses the legality of online hearing aid sales in which the consumer never sees a professional. A section of the kit entitled Regulations for Internet Sales of Hearing Aids states, “The introduction of hearing aid sales via the Internet has raised many concerns and questions about the legalities of these types of models.” Adherence to FDA regulations and state requirements for the sale and dispensing of hearing aids, it says, is “of critical importance.”
It adds, “Without the involvement of hearing healthcare professionals in the fitting of amplification, patient safety may be in jeopardy.”
The section notes that the FDA has stated that it will investigate direct-to-consumer Internet sites to determine if they are in compliance with its regulations. It also advises members that they can report concerns about the sale of hearing aids to the FDA at email@example.com.