HA Business model


#1

Has anyone noticed if local audiologists have changed their business model in the past couple of years with the new rules regarding HA dispensing? I would expect their business model to change with lower prices and more ah la carte services. Be interested in opinions.


#2

Sure, the industry has no choice but to head in two directions. The discount end is grabbing more business at a rapid pace.

The wholesale price of a top-end hearing aid is usually less than $400. At about $3k a pop, one needs a lot of fitting time to get good value for money spent. Some people do and it’s worth every dollar. But most people, especially with “routine” or moderate age-related hearing loss, probably don’t need much time with a fitter. For them, Costco and other discounters are the way to go.


#3

Wholesale for top end is nowhere near that. You might get heavily discounted mid-range stuff for that money - in sterling but that’s £300 - no major manufacturer will put their high end product out for that.


#4

Did I miss it? What new rules? Is this in the USA or elsewhere?


#5

New rules??? The big change that is coming is the OTC (over the counter) classification of hearing aids. The FDA is now charged with making rules to accommodate the OTC. It is not here yet but is certainly coming. More practices will probably unbundle their prices. Some may go the “concierge service” route and offer more services and conveniences to the patient. Many will offer the OTC products and charge for the testing and fitting of the OTC. No one really know what will play out with the OTC product yet.


#6

I did find this reference but not sure how different it is:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.420
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES

Help | More About 21CFR

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2017]
[CITE: 21CFR801.420]