The END of Dispensing Hearing Aid Professionals?

By Roy Binder, ACA, BC-HIS posted 11-03-2015 16:25

  

The END of Dispensing Hearing Aid Professionals?

On April 27, 2009, President Obama announced the President's Council of Advisors on Science and Technology (PCAST). PCAST is an advisory group of the nation’s leading scientists and engineers who directly advise the President and the Executive Office of the President. PCAST makes policy recommendations in the many areas where understanding of science, technology, and innovation is key to strengthening our economy and forming policy that works for the American people.

October 2015 PCAST released a report and their recommendations for Accessible and Affordable Hearing Health Care for Adults.

If their recommendations come to fruition, ALL dispensing Audiologists and Hearing Aid Specialists will cease to exist.

Please read their recommendations and pass it on to as many dispensing professionals as possible. To wait and see what will happen is a kiss of death to our professions.

PCAST makes the following recommendations:Open up the market for innovative hearing technologies

Recommendation 1. FDA should designate as a distinct category (“basic” hearing aids) non-surgical, air conduction hearing aids intended to address bilateral, gradual onset, mild-to-moderate age-related hearing loss and adopt distinct rules for such devices.

(a) FDA should approve this class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser. FDA should also approve for OTC sale, both in stores and on-line, tests appropriate to the self-fitting and adjustment of these OTC devices by the end user. Such hearing treatments and tests meet the FDA requirements for OTC products, which are that consumers should be able to self-diagnose, self-treat, and self-monitor the condition.

(b) FDA should exempt this class of hearing aids from QSR regulation in its present form and substitute compliance with standards for product quality and recordkeeping appropriate for the consumer electronics industry, developed by an appropriate third-party organization and approved by FDA. Similar actions should be taken with respect to diagnostic hearing tests used to dispense and fit Class I hearing aids.

Recommendation 2. FDA should withdraw its draft guidance of November 7, 2013 on Personal Sound Amplification Products (PSAPs). PSAPs should be broadly defined as devices for discretionary consumer use that are intended to augment, improve, or extend the sense of hearing in individuals. PSAP manufacturers should continue to be able to make truthful claims about their use in normal settings. FDA should not require language in PSAP labeling or advertising that excludes their use by individuals with age related hearing loss no worse than mild-to-moderate.

 Recommendation 3. Analogously to its “Eyeglass Rule,” FTC should require audiologists and hearing aid dispensers who perform standard diagnostic hearing tests and hearing aid fittings to provide the customer with a copy of their audiogram and the programmable audio profile for a hearing aid at no additional cost and in a form that can be used by other dispensers and by hearing-aid vendors. Also analogously, the availability of a hearing test and fitting must not be conditioned on any agreement to purchase goods or additional services from the provider of the test.

 Recommendation 4. Similarly in effect to its “Contact Lens Rule,” FTC should define a process by which patients may authorize hearing-aid vendors (in-state or out-of-state) to obtain a copy of their hearing test results and programmable audio profile from any audiologist or hearing-aid dispenser who performs such a test, and it should require that the testers furnish such results at no additional cost.

While FTC has the authority to issue new regulations of this sort, action can be accelerated and strengthened by legislative direction. We urge the Administration to work with Congress to initiate bipartisan legislation that would instruct FTC to issue a rule for hearing aids and PSAPs similar to the eyeglass and contact lens rules.

In summary, PCAST finds that the costs and risks of inaction with respect to untreated hearing loss in the aging U.S. population are large. PCAST finds that the unnecessarily high price of hearing aids for individuals and the conspicuously slow pace of innovation by their manufacturers compared with other consumer electronics are consequences of a concentrated and increasingly vertically integrated incumbent industry, operating in the context of longstanding Federal and State regulations that appear to discourage potential new entrants. PCAST recommends specific actions by FDA and FTC that would have the effect of opening up the market for innovative hearing technologies and increasing opportunities for consumer choice.

Solution:Option #1) We can all sit around and wait to see what happens and hope it just goes away. Option #2) ALL dispensing hearing aid professionals including Audiologists and Hearing Aid Specialists to join together and fight this as ONE group ( Better choice!)

Your opinions are welcome!

 



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03-19-2016 16:41

This was an interesting read. Gwendolyn when will you be posting the rest of your comments? As a Hearing Instrument Specialist, I have always preached against mail order hearing aids, internet sales, and PSAPS. When people self treat, earwax, ear infections, and brain tumors can go undetected. I never understood why people were allowed to sign waiver to forgo seeing a doctor and a hearing test as well. I thought it was illegal. At least it was in Wisconsin. I never knew until recently that the Federal Regulations were as lax as they were. What I would like to see, is that our manufacturers provide us with hearing aids that cost us $200.00 so we can have an affordable option for those those who would purchase the hearing aids on line to save money. if it were an American made hearing aid it would be best. If people knew that a lot of those PSAP's were made in China they might come to us first to get one that was Made in America if it were similarly priced. Or, maybe we should sell the PSAP's and other amplifiers in our offices offering a bigger array of products for our patients. You might think I am crazy for saying that. If we can't get PCAST to change their minds we will have to offer more products for sale. My practice is starting to be known as the phone store, we are now getting into the Hearing Protection Industry, and I am also thinking about the hearing loop market as well. With all the changes in our industry we need to expand our offerings. Now is the time to prepare for the future. It is coming fast and we cannot afford to to be left behind.

02-24-2016 08:52

Go to website below to register your comments and opposition to PCAST report directly to FDA....

https://www.federalregister.gov/articles/2016/01/07/2016-00065/streamlining-regulations-for-good-manufacturing-practices-for-hearing-aids-public-workshop-request#open-comment

02-23-2016 16:21

Roy: Thank you for being informed and attempting to bring this out in the light. It’s simply amazing how absurd some of the recommendations are from PCAST. However, it’s just as startling how little opposition is being mounted to combat those recommendations. I noted that most dispensers I have spoken with regarding this matter have not even read the 15-page report…. when I have more time I will post the four major recommendations and my personal opinion.
However, here is the link to that pdf for anyone having trouble finding it, if you are a dispensing Audiologist or Hearing Instruments Specialist, I recommend you read it:
https://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf
Mr. Taylor: I assume Roy is calling on us to fight the ridiculous recommendations in the report. I assume he is suggesting to fight for your career (unless you have decided to retire). I certainly hope you don’t feel a citizen can be better served testing and fitting their own hearing aids over your own services! Or getting fitted from a kiosk at the drug store, app from their phone, guy in the back of a gas station???
I am curious, what digital tsunami do you think you will be riding coming from this report’s recommendations? Do you plan to offer these: http://ihearmedical.com (They are already fda approved) if you think this is a better option than what you offer within your practice than by all means ride that digital tsunami. I think having a diagnostic test with proper equipment from a trained specialist and then fitted properly with quality hearing aids serve citizens much better. Have you even read the report? They deregulated hearing aids in Japan and now Japanese citizens go to electronics stores or jewelry stores for fitting/programming…It hasn’t worked out very well. There are actually less people wearing hearing aids after deregulation (according to recent survey) and just more drawers at home full of junk hearing aids.
To all: You can visit the following link to learn more about attending or even sending electronic comments on opposition.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm
I am personally attending and will be speaking against this ridiculous report! The meeting will be webcast. You can contact susan.monahan@fda.hhs.gov. to submit your written comments and or for further.
I hope they FDA blasts this report (which by the way was not developed by one Audiologist, ENT or even a H.I.S.)
I am passionate about this topic and this report not because I am scared I may lose customers but because it’s not in the best interest of citizens. My daughter has a profound hearing loss, I would be delighted if stem cell research cured all loss and hearing aids were a thing of the past.
These recommendations do not help hearing impaired.
Keep up the fight Roy!
Gwen

12-16-2015 07:55

Dan,
Thank you for responding.
Can you please offer your take on the PCAST’s recommendation to deregulate hearing aids, reclassify PSAP’s, and allowing OTC and internet sales of hearing aids?
Are you in agreement, disagreement or neutral with the PCAST recommendations and if so, can you please elaborate on your position?
In advance, thank you
Roy

12-15-2015 11:03

Just exactly what is it that you are calling on to fight?
Putting and pitting ourselves against the substantial science that indicates an incredibly small risk to the general public from self fitting serves us how?
Are we to presume to continue to make hearing healthcare decisions for the public under the guise of knowing what's best for every consumer?
Are we continuing to demand that they see us before addressing a hearing loss in any way that excludes us as professionals?
If so, how do we square this with both the consumer's own choices in the matter, as well as the natural evolution of ear worn signal processing gear that delivers sounds processed from all manner of inputs?
Is this fight an attempt to hold back a digital tsunami that we should be trying to ride rather than hold back?
Again, just what and how do my colleagues anticipate our tail wagging this dog?
Happy Holidays,
Dan......

12-02-2015 10:24

The AAA and other audiology groups have failed, in many states, to marginalize the Hearing Aid Dispenser position, so this looks like a back door way to control the industry they want to control. If they make PSAD devices like hearing aids for the poor/under-served, they will effectively put us out of business and cause great danger for the hearing aid wearer. The IHS and FSHHP are both on board to fight this recommendation.
Ben Brody, HAS, BC-HIS
Secretary, FSHHP.