According to news reports from Washington, DC, US Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa) have announced that they will introduce the Over-the-Counter Hearing Aid Act of 2016. The bipartisan bill would make certain types of hearing aids available over the counter (OTC) and remove “unnecessary and burdensome” requirements that currently create barriers for many consumers who could benefit from hearing aids.
Approximately 30 million Americans experience age-related hearing loss, yet statistics indicate that only about 14% of those with hearing loss use assistive hearing technology, often because they cannot afford costly hearing aids.
“Millions of people in Massachusetts and across the country experience hearing loss as they get older, but are unable to get the hearing aids they need because of high costs and complicated regulations,” Warren said. “This bipartisan bill is a simple fix that that will make hearing aids easier to access and, unlike in the current marketplace, will make it easier for consumers to shop for the best value.”
“I hear from Iowans about the high cost of hearing aids, and I understand the concern,” Grassley said. “If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. More consumer choice and convenience are what we want to accomplish with this legislation. This won’t affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted. The over-the-counter option is for those who would benefit from a simpler device.”
The Over-the-Counter Hearing Aid Act of 2016 would allow hearing aids that are intended to be used by adults to compensate for mild-to-moderate hearing loss to be sold over the counter, and would eliminate the requirement that people get a medical evaluation or sign a waiver in order to acquire these hearing aids. It also asks the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids and update its draft guidance on Personal Sound Amplification Products (PSAPs).
The Over-the-Counter Hearing Aid Act implements recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine, which have both issued reports recommending making some types of hearing aids available over the counter and removing the requirement of a medical evaluation in order to allow millions more Americans to access hearing aids. Out-of-pocket costs for a single hearing aid currently average around $2,400. According to a report by PCAST, “There is considerable evidence that hearing aids can be profitably sold for a fraction of today’s end-user cost.”
The text of the senators’ bill is available here, and a fact sheet is available here. The legislation will be introduced when the Senate returns to session.
To view opinions about this issue as expressed by thought leaders in the hearing healthcare industry, please refer to the Hearing Review website’s September 28, 2016 Commentary from ASHA President Jaynee Handelsman, PhD, CCC-A, and the October 14, 2016 Counterpoint from Brian Taylor, AuD, and Stephanie Czuhajewski, CAE.
Source: Newsroom for Elizabeth Warren, US Senator for Massachusetts
All for it ( actually sometimes wear one in one ear …)
But why not just make hearing loss a medical diagnosis and have it covered under your health insurance ! So The insurers can negotiate prices for the patients….
What you are ignoring is that the current status of delivering hearing services is unnecessarily expensive, to the point that the majority of persons who could benefit from your services and aides are unable or unwilling to use the current resources. Several thousand dollars for small electronic devices makes no sense when you can buy state of the art electronic devices of much greater sophistication for far less. Have you considered a “public health” model instead? Why not provide audio logical services through local public health agencies, and use the power of large buying power to drive down the cost of the devices?
What ev r you support, I hope (as a non audiological professional) that you consider means to reduce cost and increase accessibility to professional serves and necessary components to them solution. Thank you.
I’m afraid, based on what I’ve read so far about this bill, that this legislation has far less to do with truly helping individuals with bona-fide hearing loss than it does Democrats once again trying to build their base of constituents. To argue the obvious benefits of being fitted by a licensed and skilled practitioner versus self-evaluations and fittings would be redundant here, so I will refrain. I agree on all points with those professionals who oppose OTC hearing devices for the very reasons stated by said professionals. Regulations are a two-way street to protect both the fitter and the patients. Over-regulation will, as it is intended, oppress our industry because it lacks the insight and understanding needed for balance.
Comparing OTC hearing aids to reading glasses is completely misleading for the consumer. There is no way for the patient to know what type or degree of hearing loss they have without seeking medical advice and a hearing aid evaluation. The patients may be saving money on the actual device, but what happens when it doesn’t fit, when it feeds back, when it doesn’t have enough amplification or when they need maintenance and do not know what to do to fix it? Who do they seek for follow up care? Are we as audiologists allowed to charge this population for their visit? And, then what kind of money are they saving if they have to pay us for our time and expertise? I believe these devices may have their place, but I also believe that it does a disservice to our patients and they need education about hearing loss and hearing aids. The people writing this law need some serious education about hearing loss and hearing aids as well.
I would ask the political pair that are putting this bill forth to consider the danger they are putting “self curing” people in. These devices enter a body cavity which could contain wax, bacteria, foreign material, etc, all of which could multiply under heat and moisture when sticking an object in the ear. They are asking for a flood of ear infections among “self curing” people…and, possibly, mastoid problems and more. Think about it…there is a need for guidance and monitoring.
Dr, Mendelson, Your comment about sticking a contaminated earpiece in the ear causing all kinds of infections is based on what? I have been wearing hearing aids since 1990 and never had an infection in my ear. Once I walk out into the street with my hearing aids and start using them the person who sold them to me does not follow me home and clean my hearing aids for me; so what’s the difference. I suspect that more germs are introduced into ears by people using everything from a paper clip to their little finger to address and itch or dig out wax.
The proper fitting of amplification for a sensorineural or conductive loss is every bit as critical and time consuming as the proper fitting of corrective lenses for myopia or hyperopia. It requires a personalized prescription based on careful assessment in order to achieve any degree of natural sounding hearing correction in the same way that prescriptive lenses cannot be pulled off a shelf with the expectation of approaching near normal vision results. No one wants to just be able to hear for a moment and then return to a state of hearing impairment. Hence the comparison to OTC “readers” is more than inaccurate.
I have frequently fit patients who had attempted the OTC route of using Personal Sound Amplification Products in order to save money only to shelf them as soon as a correctly fitted set of hearing aids could be procured. This is not money saved, it is money wasted. In addition, there is no need to pass an Over-the-Counter Hearing Aid Act of 2016. These near worthless products are already on the market and available in department stores and through junk mail publications.
Dr. Christensen, As an engineer and hearing aid user since 1990 I can appreciate your view expressed in the 1st paragraph; but you are assuming that all OTC users require the same degree of fitting and adjustment that can only be done in an office such as yours. I submit to you that this is not the case with the advent of hearing aids that can be tailored by the user via a smartphone, I submit to you that this puts the judgement of the most natural sound and the best fit into the hands of the person who knows best what he/she is hearing. Yes they may not have access to a calibrated Speech Ineligibility Rating (SIR)test; but many licensed practitioners do not use SIRs and most of those that do use a live person to read the words in an very un-calibrated, un-standardized way. I am now retired and my 15 year old hearing aids have worn out; but I cannot afford to replace them with today’s pricing of several thousand dollars per ear.
Regarding your 2nd paragraph, I believe that the OTC hearing aid industry could be required to produce products that are useful if they were held in compliance with certain basic standards by the FDA. I would go so far as to require the manufacturer to prove to the FDA that their product meets requirements via having tests by an independent laboratory provided.
There are situations which warrant an OTC hearing aid. Pure conductive loss is one. Hospice and advanced aging situations where additional trips to health care facilities are not practical are another. Should the single-sided deaf pay $800+ to find out that someone is addressing them on their deaf side when an air-conduction aid with 20 dB of gain for the deaf ear side will solve the problem? We need to address the many practical issues that face the needful. Dogmatic opposition to the OTC option is wrong and risks public contempt. Go and visit an assisted care facility. These are vulnerable people. This is denial of care to immobile individuals with limited financial means.
Hard to believe no one in our profession has explained the difference between nerve damage resulting in hi frequency hearing loss and the precision needed to correct that, and simply wearing magnifying glasses on your face to compensate for myopia to Sen Grassley and Sen Warren
Yet, there are situations which do warrant an OTC hearing aid. Pure conductive loss is one. Hospice and advanced aging situations, where additional trips to healthcare facilities are not practical, is another. Should the single-sided deaf pay $800+ to find out that someone is addressing them on their deaf side when a simple 20 dB of gain on the deaf side will solve the problem? We need to address the many practical issues that face the needful. Narrow understanding and dogmatic opposition is simply wrong.
I am objecting to the comparison to over-the-counter eyeglasses. Sean Hannity is selling over the counter hearing aids in his radio show and has been for sometime. He soaks people for $1600 a pair. As long as its presented in a way that people can get 100% of their money back when it falls out of their ear or makes it sore or gives them for results I really don’t have a big objection to it. But it is in no way similar to a simple magnification issue. Louder is not better when it comes to understanding speech in noise and having a comfortable fit inside an ear canal is in no way as easily accomplished as balancing glasses on the bridge of the nose. The final point would be a proper fitting hearing device maybe worn 16 hours a day where cheater eyeglasses are worn for a few minutes to a couple hours at a time. We hear in the mind not in our ears. taking hearing devices off and putting them back on in a way that somebody would with cheaters degrades understanding ability it does not improve it.