This week, HHTM welcomes long-time contributor, Amyn Amlani, PhD, as the new editor of Hearing Economics. While Dr. Amlani has written several well-received articles for HHTM over the years, today we’re republishing a very popular and timely post he authored on OTC hearing devices, originally published here on 8/22/17.

 

by Amyn Amlani, PhD

The reality of over-the-counter (OTC) products becoming federally regulated took one step closer to certainty last week. The FDA Reauthorization Act of 2017 (HR 2430), which includes provisions for OTC hearing aids for adults with perceived mild-to-moderate hearing loss, passed successfully through the US House of Representatives in July 2017 and through the US Senate in August 2017, and was signed into law by President Trump late last week.

While this bill will improve consumer access to a low-cost alternative to traditional hearing aids, the literature on OTC performance and patient outcome is still in its infancy. In fact, the preconceived notion—from the provider side—is that OTC devices are inferior in performance to traditional hearing aids, and thus performance and patient outcomes will be compromised compared to a traditional hearing aid.

In this post, we take a closer look at the existing literature on OTC electroacoustic performance, and how these electroacoustic data influence behavioral performance for devices fit by an experienced practitioner. The findings from the literature are then cast to provide insight into what the future holds for the hearing aid market.

 

Electroacoustic Performance

 

There is a growing body of research on OTCs and hearing aids that indicates, “You get what you pay for.”1-5

In general, OTC devices and traditional hearing aids that retail for less than $150 and $500 per unit, respectively, tend to yield unacceptable levels of equivalent input noise (EIN) and total harmonic distortion based on ANSI standards for traditional hearing aids. These same, economically-priced devices provide insufficient high-frequency amplification and too much low-frequency amplification for moderate degrees of hearing losses relative to a prescriptive target.

For OTC devices and hearing aids retailing for more than $150 and $500 per unit, respectively, the literature indicates that most devices provide acceptable electroacoustic tolerance levels relative to the ANSI standards for traditional hearing aids. These same, premium-priced devices tend to yield appropriate levels of amplification for moderate degrees of hearing losses relative to a prescriptive target.

 

Behavioral Data

 

Economy Line OTC Data

 

Based on the categorical findings of the electroacoustic data, the data suggest that economy line OTC devices (i.e., priced under $150) are inferior to traditional hearing aids.

To validate this notion, Amlani and colleagues6 compared participant responses of sound-quality attributes (e.g., comfort, clarity, intelligibility) in three listening conditions:

  1. speech recorded in quiet
  2. speech recorded against multitalker babble at a +4 signal-to-noise-ratio
  3. speech recorded in a echoic environment having a reverberation time of 1.17 sec

for four amplification products:

  1.  the participant’s own premium level device (i.e., retail price > $2600 per unit)
  2.  an economy level hearing aid (i.e., retail price < $300 per unit)
  3. a smartphone-based hearing aid application
  4. an economically priced  OTC device (i.e., retail price < $150 per unit).

For each sound-quality attribute measured, and in all three listening conditions, the OTC product (product #4) was rated poorest compared to the other amplification products. This finding was highly correlated with the fact that the gain for the OTC product differed from the participant’s premium-priced hearing aid (product #1), which was programmed and verified to a prescriptive target, by an average of 13 dB in the high frequencies (between 2000 Hz and 6000 Hz).

Our finding of reduced performance/preference with less expensive OTCs has also been reported by others.7,9

 

Premium Line OTC Data

 

Conversely, the literature shows that premium OTC devices (i.e., priced above $150) tend to provide similar performance to traditional hearing aids. Rønne and Rossing,7 for instance, found similar sound-quality preferences between a premium traditional hearing aid and a premium OTC product.

Xu et al8 compared aided sound-quality preferences between two traditional, premium level hearing aids and two premium OTC products using a paired-comparison approach for three listening conditions: speech in quiet, speech in noise, and music. Results revealed that the OTC products performed as well as hearing aids for speech in noise and music, but not speech in quiet.

More recently, Reed and colleagues9 compared speech understanding in noise for a hearing aid and five OTC products (4 premium, 1 economy). Results revealed similar speech understanding performance between the hearing aid and the three most expensive OTC products (i.e., retailing at prices > $299.99). Speech understanding performance declined for the two lower prices OTC products. Specifically, speech understanding performance with a OTC product retailing at $269.99 was reduced compared to the traditional hearing aid and three, more expensive OTC products. The lowest price OTC device, retailing at $29.99, significantly degraded speech understanding ability compared to all other amplification products.

 

Implications

 

Like it or not, OTC products are here and they will be a disruptive force to the existing marketplace. OTCs have the opportunity to enhance the marketplace through increased awareness of hearing desensitization; increased need for regular audiological maintenance and the need for hearing protection in certain noisy environments; and a means for the public to reduce its stigmatism towards hearing aids.

However, to enhance this opportunity to grow adoption rates of audiological services and technology, there is a critical need to define minimum standards of electroacoustic characteristic performance of OTC products entering the market.

The literature review to date suggests that to meet this standard, the retail price floor for OTCs resides around $300 per unit.

To meet this minimally acceptable electroacoustic standard at this retail price point, it is imperative that economy-priced OTC manufacturing firms increase production costs to provide a standardized product. Any tomfoolery by manufacturers to circumvent a high standard in production and design will negate the opportunity for growth in this market.

Assuming that the manufacturing standards are adhered to, providers who fit their patients with OTC devices in their practices can expect roughly a 5% to 7% increase in first-time users entering the market, with a conversation rate of about 30% of OTC users transitioning to traditional hearing aids on an annual basis. The lag time from OTC purchase to traditional hearing aid adoption is a bit tricky to estimate mathematically given that this event is a first in our professional evolution. However, using optometric data for eyeglass reader to prescriptive lens, the best guess for a lag time appears to be between 18 and 30 months.

 

References

 

  1. Cheng CM, McPherson B. (2000). Over-the-counter hearing aids: Electroacoustic characteristics and possible target client groups. Audiology, 39: 110-116.
  2. Callaway SL, Punch JL. (2008). An electroacoustic analysis of over-the-counter hearing aids. American Journal of Audiology, 17, 14-24.
  3. Chan ZY, McPherson B. (2015). Over-the-counter hearing aids: A lost decade for change. Biomedical Research International: 827463.
  4. Smith C, Wilber LA, & Cavitt K. (2016). PSAPs vs hearing aids: An electroacoustic analysis of performance and fitting capabilities. Hearing Review, 23(7):18.
  5. Reed NS, Betz J, Kendig N, Korcak M, & Lin FR. (2017). Personal sound amplification products vs. a conventional hearing aid for speech understanding in noise, Journal of the American Medical Association, 318: 89-90.
  6. Amlani AM. (2017). Sound-quality ratings of traditional and over-the-counter amplification products obtained under real-world- and laboratory-listening conditions. Invited presenter, British Society of Audiology, Harrogate, United Kingdom, June 29-30.
  7. Rønne F, Rossing R. (2016). Are hearing aids the better rehabilitative choice when compared to PSAPs? Hearing Review, 23(11): 26.
  8. Xu J, Johnson J, Cox R, Breitbart D. (2015). Laboratory comparison of PSAPs and hearing aids. Paper presented at: Annual meeting of the American Auditory Society, Scottsdale, Arizona, March 5-7. Available at: http://www.harlmemphis.org/files/9814/2593/1864/XuAAS2015_PSAPs.pdf

Originally published on 8/14/2012,  Ethics of Stealing and Deception, is a post in Hearing Economic’s “But That Would be Wrong” series. It has garnered the most readership of any post at Hearing Economics over the years.

 

Last time Hearing Economics described thefts and deceptions in professional settings. Transgressions were bizarre, some absurd, but all actually happened. Most were illegal; all received some form of punishment.  The point was that owners and managers are responsible for imposing and enforcing checks and balances in hearing healthcare environments in order to protect patients, staff, and assets from theft and manipulation.  Indeed, checks and balances are important preventive measures put in place to protect people from making bad choices and create a reliable, trusting environment.  

Which brings us to the topic of today’s post: Illegal or not, do situations exist in which stealing or deceptions are ethically defensible in hearing healthcare environments?  I think I’m on reasonably firm shifting sand when I say that the Economic view is that all are OK so long as they are not illegal and are done for the good of the firm. Readers are encouraged to send in stories of legal stealing and deception that helped their companies prosper — I’m sure we could all benefit from such information.

While we anxiously await examples, it’s worth a minute to define terms.  Bad behavior is often described as “morally and ethically wrong.” But seriously, does anyone reading or writing this post know the difference between moral and ethical?  Can something be morally right and ethically wrong, or vice-versa? This area has consumed the life of more than one philosopher, so don’t look for an answer in this post.  However, I was encouraged to dig a little when I discovered that I could ask the Universe on its brand new twitter account.  I haven’t heard back from The Universe–making me wonder fleetingly if I am just a speck–but I quickly left that path to seek out more reliable, or at least closer, experts.  Somewhat tautologically, it turns out that morals are beliefs and ethics are “advanced expressions of morality”2 based on consistent reasoning.  You have to wonder how consistent rationalizations are handled.

You’re in the moral ballgame if your gut tells you that a proposed act is “wrong” (e.g., stealing from the business) or “right” (not stealing).  Rushworth M Killer, deceased ethicist and author of How Good People Make Tough Choices calls these “right-wrong” decisions moral temptations: clear-cut decisions about behaviors that are widely “understood to be wrong” and provide excellent career opportunities for televangelists.  Dealing with what Dr. Killer calls “right-right” decisions moves you up to the big leagues of ethical dilemmas, where choices set one central value (not stealing is good) against another (taking money from the wealthy to feed the poor serves the Greater Good) “in ways that will never be resolved simply by pretending that one is wrong.’”  So much for rationalizing… ethics requires honesty in one’s thinking.

How about those transgressions in healthcare mentioned last week? Were they moral temptations or ethical dilemmas?  What is the economic view?  Below are a few examples, grouped according to the aforementioned Central Values pitted against the good of the firm.1

Central Value:  Family Matters

  • The poor accountant last week embezzled $16 million, but her motive–only now revealed–was pure.  She used that money unselfishly to prop up her son’s failed ambulance business.  The big picture emerges:   A mom helping her son, a family business, ambulances saving people’s lives, the world a better place.  Ethically, how can you blame the woman for repurposing that money to such a worthy cause?
  • A close-knit family business in Long Island employed 11 family members who provided Special Ed services to disabled toddlers.  In the process, the business is accused of falsifying records and overbilling about $2mil.  But hey, the kids got (some) services, the family prospered, and $2 mil is a drop in the bucket in  the program’s $2 billion budget.  
  • “Your office manager confesses that she stole money from the office account to buy medicine for her ailing father. Her father has died, and she offers you a check from the insurance proceeds to pay you back. After you cash the check, do you fire her or forgive her?” 3 

Comment:  With notable exceptions (Robin Hood, Soprano family) most of us will see these examples as moral temptations rather than ethical dilemmas.  It is wrong to steal.

On the other hand, it is not only OK to steal but stealing is a cornerstone of Robin Hood and Tony Soprano ethics – one ethic says it’s for the Greater Good of the Family of Man, the other’s ethic says it’s for the Good of The Family.  Not stealing (or not doing other wrong things) would be an ethical dilemma for those bound by oath to organizations such as these. 4 

The Economic view is clear cut for the three cases, unless the Sopranos go into healthcare.  Stealing from the firm raises Costs, which reduces Supply, raises Price, and cuts Demand.  Not good for the Business.  Not good for Consumers.  Separate the transgressors from the Business and get the stolen funds back, using legal means if necessary.  Beyond that, any punishments are the purview of the courts.

In general, professions are not well served by instances of moral and/or ethical failure.  The ripple effects of such failures tend to reach consumers, who react by complaining.  Complaints get the attention of agencies, which in turn react by applying scrutiny to the profession. Life gets really rough when Government agencies move from scrutiny to regulations and investigations of the profession and its members.  Just ask Tony Soprano, who practically lives with the Feds in his house.  He’ll tell you:  it’s a lot easier and far more profitable to police your own organization than have the Government step in or, worse, take over.  

Next week, back to Government Regulation in hearing healthcare.  Click here if you want to jump to the 3rd post in the “Wrong” series.

 

Footnotes

 

Readers are reminded that “the firm” in economics refers to all non-government entities making transactions of Supply and Demand, either for-profit or non-profit. 

2 This quote surfaced years ago when the post was written. The link is now broken, attribution can no longer be given, but someone other than me said it.

This conundrum is provided courtesy of Dr. Rushworth M. Killer.

4 The ethical dilemma of organizational omerta deserves further scrutiny. I’ll revisit it when membership organizations’ ethical codes come up.

 

*featured image courtesy moneycrashers