Ian Windmill, PhD

by Barry A. Freeman, Ph.D. and Ian Windmill, Ph.D.

Barry Freeman, PhD

In the January/February AAA President’s Message, Dr. Ian Windmill discusses the recent FDA, NAS, and legislative activities surrounding affordability and accessibility to hearing care.  He notes that Audiology “suffers from an access issue. There simply are not enough audiologists…to meet current demand” and we shouldn’t be surprised by these federal activities. 

 

Anticipated Gap in Demand and Supply

 

Windmill and Freeman (2013) projected a gap between patient demand and the number of audiologists available to provide the services.  While they noted that the good news was that more people would seek audiology services in current and future years, the number of providers, however, would remain relatively flat or grow slowly in the coming decades. 

The relatively flat projected growth presented in Figure 1 is based on anticipated graduation rates and retirements from the profession.  The projected need is based on the anticipated demand for audiology services and the number of providers necessary to meet this need.  The gap between the two should not be perceived as an unmet need but, rather, a challenge for the profession to improve efficiencies, increase the number of entrants to the profession, and avoid the incursion of new providers who may want to assume portions of the audiologist’s scope of practice.

Hosford-Dunn (2017) looked at actual projections and provided some interesting insights into economic factors  as to why the audiology profession may not be growing and, in fact, may be decreasing in the number of providers.

 

Missing Component

 

However, there appears to be a missing component to these projections; that is, the actual applicants to Audiology degree programs and role of the universities in preparing sufficient graduates to meet patient demand and accessibility to hearing care.

The ASHA Higher Education Services (HES) provides data on audiology education and academic programs through surveys of programs and monitoring enrollment and graduation rates (Table 1).  Culling through this data provides some interesting trends and facts that may help shed additional light on the declining number of audiologists reported by Hosford-Dunn and predicted by Windmill and Freeman.

 

Year

Applications

Program Capacity

Enrollment

Total Enrollment

Degrees Awarded

2009-10

3,249

799

787

N/A

548

2014-15

6,017

797

784

2,793

623

Table 1.  Summary of Enrollment and Graduation data from 70 Au.D. programs in 2009-10 and comparing  to data from 71 Au.D. programs in 2014-15.

 

Table 1 is a summary of data provided by HES and suggests the pool of applicants to Au.D. programs has grown by more than 85% from 2009-10 to 2014-15.  This is not necessarily the total number of students applying because it is understood that many students apply to more than a single program.  

Hosford-Dunn refers to the AAA’s “Ask an Audiologist” marketing campaign to enhance the profession’s brand.  It appears that it has been successful as the growth in applications to Au.D. programs is significant and reveals an increasing interest in a career as an audiologist.

 

A Question of Capacity?

 

During this same time, the capacity of Au.D. programs and enrollments have not grown and may even have declined slightly (Table 1).   Program capacity and enrollments remain at an average of 11.3 students per program and, according to HES, Au.D. programs ranged in their percent of filled capacity for new enrollments to “less than 50% capacity …while others…reported exceeding 100% capacity.” 

While enrollments remain constant, graduation rates appear to be increasing.  Of course, the 2009-10 survey was completed shortly after the final transition from master’s to doctoral degrees and some reporting programs may not have had a graduating class in 2009-10.  Average graduation rates in 2014-15 were 8.7 students per program, suggesting attrition from enrollment to graduation of 20%.  A review of HES surveys from the years between 2009 and 2015 reveals similar attrition rates.  Only 80% of students enrolling in AuD programs are graduating and entering the profession. 

 

A Question of Programs?

 

Windmill and Freeman (2013) broached the topic of audiology supply when they asked whether there are too many or too few academic programs graduating audiologists.  While some may argue that there are too many academic programs in Audiology, they cautioned that the graduation rates were so low that eliminating programs might actually end up eliminating the profession since there would be an inadequate supply of audiologists to meet patient demands. 

As Hosford-Dunn recently noted, “over the last eight years, the audiology labor force decreased by 3.3%.”  While there is a positive trend of increased interest in the profession, program capacities and enrollments are flat.  There appears to be an overall decline or, at best, flat growth in the number of practicing audiologists. 

 

A Question of Accreditation Standards?

 

When academic programs were asked by HES to explain their primary reason for not increasing enrollments, they reported that the primary factor impacting enrollment was “insufficient clinical placements” and getting students the required clinical clock-hours. This is surprising and somewhat disappointing considering that all of the programs reporting data to HES are accredited by the ASHA Council on Academic Accreditation (CAA) and CAA has no reference to clinical clock hours for Audiology students in their accreditation standards and clock-hours are not required for program accreditation or student graduation. 

The CAA Accreditation Standards for Au.D. programs state that programs should have “appropriate courses and clinical experiences.”  The accreditation standards require,

“Doctoral-level programs in audiology must provide evidence of a curriculum that allows students to achieve the knowledge and skills…[with] the aggregate total of clinical experiences must equal at least 12 months, to include direct client/patient contact, consultation, record keeping, and administrative duties relevant to professional service delivery in audiology. The program must provide sufficient breadth and depth of opportunities for students to obtain a variety of clinical experiences in different work settings, with different populations, and with appropriate equipment and resources in order to acquire and demonstrate skills across the scope of practice in audiology, sufficient to enter independent professional practice.” 

We often hear about the challenge of students attaining 1820 clinical-clock hours and that is a stated reason why academic programs will not enroll more students.  However, clinical clock-hours only are required for ASHA certification and not academic program accreditation.  Programs should not blame insufficient clinical experiences for clinical clock-hours as an excuse to not increase enrollments and meet the current and future needs of the profession.  It is not a requirement of their accreditation standards.

 

How to Meet Demand

 

It is clear that access to hearing care will remain an issue since an increase in the number of licensed audiologists is not on the horizon with current enrollments and graduation rates.  In order to avoid someone else stepping in and taking over the scope of practice, audiologists must develop and adopt technology advancements to improve clinical efficiencies and increase the role of audiology-extenders such as Audiology Assistants to meet the demand of patients. 

 

References

 

Higher Education Archived Data Reports, ASHA.   

Hosford-Dunn, H. 2017 New Year’s Resolution:  Demand an Audiologist. HearingHealthMatters.org, Jan 3, 2017.

Hosford-Dunn, H. How Much and How Low, Audiology Workforce part 2.  HearingHealthMatters.org, Jan 10, 2017. 

Windmill IM & Freeman BA.  Demand for audiology services: 30-yr projections and impact on academic programs.  JAAA 24:407-416 (2013).

Windmill, IM and Freeman, BA.  If there’s a surfeit of AuD programs, what do we do? Vote ‘em out?  Hearing Health Matters, July 24, 2013.

Windmill, I.M., Where is the outrage?  Audiology Today Jan/Feb, P.10-12 (2017).

 

Barry Freeman, PhD, is Vice President of ZPower Battery, LLC.  Dr. Freeman was founding Chair of the Audiology Department and a Professor of Audiology at Nova Southeastern University and continues to maintain adjunct appointments and teach at several audiology programs.  Before returning to academia in 1997, Dr. Freeman owned and practiced for twenty years at the Center for Audiology in Clarksville, TN.  He is a past-president of the American Academy of Audiology and received the Distinguished Achievement Award from the American Academy in 2006. Ian Windmill, PhD, is Director of Audiology at Cincinnati Children’s Hospital Medical Center and Professor in Otolaryngology at the University of Cincinnati School of Medicine. 

by Harvey Abrams, PhD.

Harvey Abrams PhD

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.

As we all know by now, the third shoe (or was it a boot) dropped with a loud thud heard ’round the industry. The FDA appears to be investigating the feasibility of creating a new category of basic hearing aids that adults can purchase as an over-the-counter (OTC) device without medical clearance, prescription, or an evaluation by licensed professionals.

 

Consensus and Predicament

 

The PCAST supports this; the NAS supports this; HLAA, the leading consumer group for people with hearing loss, supports this; 2 Senators from opposing political parties support this, and even the former President of the United States supported this (and there’s no reason to believe that our current President will not support it as well). In an era of bitter bipartisanship, isn’t it interesting (and not a bit ironic) that the one issue that seems to bring everyone together in this great Kumbaya moment is the high cost of hearing aids!  

It’s not my intention to relitigate the flawed assumptions that, in particular, formed the basis of the PCAST report, nor review how we got ourselves into this predicament but, rather, I’d like to discuss some of the issues that will likely impact the pace and scope of implementation of a change in FDA regulations and, more importantly, how we can take advantage of these developments.

 

OTC Issues

 

It is important to remember that the creation of an OTC class of devices is not a fait accompli. In its press release announcing the suspension of its medical examination/waiver requirement, the FDA references the OTC issue as follows:

The FDA intends to consider and address PCAST and NAS recommendations regarding a regulatory framework for over-the-counter hearing aids without the requirement for consultation with a credentialed dispenser. The agency is committed to seeking additional public input before proposing such an approach.

The release reminds the public that, The FDA … protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The bill introduced in the last Congress, The Warren-Grassley Bill (S9) (which needs to be reintroduced in the 115th Congress) also addresses the issue of safety: the legislation requires FDA to include requirements that provide reasonable assurances of the safety and efficacy of OTC hearing aids, describe the requirements under which the sale of OTC hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, and  determine whether OTC hearing aids require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.

 

Steps in the Process

 

Several important things must happen before we see a new category of hearing aids (note that OTC products are already abundantly available).  

  • The legislation must be passed by both houses of congress and signed into law by the President;
  • The FDA must promulgate and publish an initial draft of the new rules which comply with intent of the legislation with specific attention paid to the issues of safety;
  • The FDA must allow a period of comment which is typically 90 to 180 days following which the FDA must, by law, read and analyze all of the major comments, and then issue a final rule;
  • The final rule will need to go through an internal review process before being issued.

 

A State-Side Stumbling Block

 

And here is another interesting provision of the proposed legislation that may create some heartburn, particularly among states-rights advocates. The language of the bill specifically prohibits the states from establishing or continuing in effect “any law, regulation, order, or other requirement related to the manufacturing, marketing, sale, customer support, or distribution of over-the-counter hearing aids.”

In effect, the legislation would strip consumers of state-mandated protections, such as refunds, leaving the consumer in a “caveat emptor” position and the states powerless to do anything about it. One could argue that the consumer is still protected by other existing state consumer rights laws but don’t forget, these OTC products will be regulated by the FDA – they continue to be medical, not consumer, devices.

 

A Call for Evidence-Based Policy Decisions

 

From a personal perspective, I do not object to OTC products. I believe they can represent, for the right individual, an important and potentially effective solution to their hearing problem–a solution, in fact, that should be part of every clinician’s tool box in addition to PSAPS, hearables, wearables, brain fitness training software, assistive technology, group AR sessions, and every other technological and non-technological strategy that has been shown to effectively improve the communication function and quality of life of individuals with hearing loss.

I have no doubt that we will see improvements in OTC technology and the methods associated with self-fitting them. What objections I do have is directed toward the current rush to legislation and regulation in an environment characterized by misinformation and false assumptions voiced by our nation’s senior scientific and technology experts (e.g. OTC hearing aids and OTC eyeglasses are equivalent; mild and moderate hearing loss can be managed identically; there has been no innovation in the hearing aid industry; there is little value associated with the professional component to hearing health care, etc., etc., etc.).

 Just as we demand evidence-based practice in the clinic, we should demand evidence-based decision making by our regulators and legislators. Unfortunately, what we are currently witnessing in this rush to create a separate category of OTC hearing aids is not based on any existing body of evidence.

After a very busy year of hearings, committee meetings, reports, and press releases we have some time to catch our breath before we see a change in the FDA rules pertaining to OTC devices, particularly given the slow pace of government regulation. Let’s use this time to seriously consider how we can re-engineer what we do as professionals to truly communicate the value of our services. I’ll address those issues in my next post.

 

This is Part 22 of the Peeling the Onion series.  Click here for Part 1,Part 2,  Part 3,  Part 4,Part 5, Part 6, Part 7, Part 8, Part 9Part 10,Part 11,  Part 12, Part 13, Part 14, Part 15, Part 16, Part 17, Part 18, Part 19, Part 20, and Part 21.

 

Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice.  Dr. Abrams can be reached atharvey_abrams@starkey.com

Feature image by Ross Land/Getty, foot drop boot courtesy of rehab mart