“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.
I received a notice in my mailbox earlier this week informing me that there was $9.75 postage due on a package that my town post office was holding for me. For the life of me, I couldn’t figure out what it could be.
I suspected it had to do with some forwarded mail (I move around a lot) and for $9.75, it must have been a pretty big or heavy package. So, I went to the post office the next day to find out what it was and who sent it. It was a box (not too heavy) and, as I suspected, it was forwarded from my previous address (apparently the recipient is responsible for the costs associated with forwarding parcel post items) but the sender’s information was of no value for identification purposes.
I couldn’t figure out what was in that box or who sent it and I had to pay the postage due to open the package. Now, what do I do? Do I pay the $9.75 to find out what’s inside or do I tell the post office that I refuse delivery and always wonder what possible “treasure” I might have passed up?
No Segue but Keep Reading
On June 9th, I attended a stakeholder’s meeting in Washington, D.C. that was to serve as a follow-up to the National Academies of Science, Engineering, and Medicine (NASEM’s) publication of Hearing Health Care for Adults: Priorities for Improving Access and Affordability. The details of the meeting have been reported in Hearing Health & Technology Matters and elsewhere. The specific objectives of the meeting were to:
- Facilitate discussion on strategies for a multi-pronged approach to improve hearing health care access and affordability;
- Identify needs, barriers, and opportunities for action on hearing health care; and
- Brainstorm about new and future actions and
Much of the morning was devoted to participating in 4 breakout sessions: Public Awareness and Consumer Measures, Quality Metrics and Health Professional Education, Innovation in Services – Accessibility and Affordability, and Consumer Comparisons – Evaluation Criteria and Standardized Terminology.
The afternoon session, however, was devoted to discussion of a “For Discussion Draft” document prepared by the Federal Food and Drug Administration (FDA) entitled: “OTC Hearing Devices – Starting Points for Discussion at the June 9, 2017 Stakeholder Meeting”. Here we had the “starting points” for what might ultimately lead to a FDA regulation pertaining to a new classification of over-the-counter (OTC) hearing aids (assuming, of course, they are directed to do so following the passage of current legislation in the House and Senate and the signing of that legislation into law by the President).
The discussion items for the afternoon session were broken down into 3 major categories:
- On the package labeling
- Safety Requirements for Manufacturers
- Considerations for Quality
This last category consisted of a list of some 20 features (e.g. distortion, noise reduction, directionality, connectivity, etc.) and the focus of the discussion involved the extent to which these features should be required, if there should performance standards associated with each (or some), if the information associated with these features should be made available to consumers and, if so, how. Needless to say, there was considerable discussion (and some disagreement) among the stakeholders (academicians, hearing aid industry representatives, consumer electronics industry representatives, and patient advocate representatives).
Not surprisingly, we didn’t come to any decisions on most of the draft discussion items in the few hours available to us.
Still With Me Here?
So, what does this all have to do with my ‘postage due’ dilemma? If you’ve been following my posts for the last year or so, you’ve been on an OTC journey with me, which include the PCAST reporst, NASEM’s support of OTC hearing aids, the FDA and FTC meetings, and recent legislative efforts associated with OTC hearing aids.
All of the above has been a very costly process involving considerable time and labor invested by stakeholders and staff members involved in multiple task forces and committees, attendance at meetings, responses to published reports, promulgation of legislation, lobbying efforts in support of and opposed to the pending OTC legislation, the hundreds of articles written in, what appears to be, every small and large town newspaper across the country.
Our Mystery Package
From my perspective, we appear to be inexorably moving toward the adoption of an FDA regulation on OTC hearing aids. I don’t believe there is another example of FDA approving a medical device (or, more accurately, a delivery system for a medical device) for which there is so little evidence for its safety or efficacy. Similar to my ‘postage due’ experience, it seems to me that we are paying to see what’s inside this “OTC” package because we just don’t know what it contains, do we? We don’t know whether the contents of this box will yield improvements in hearing healthcare accessibility and affordability, or if what we find inside is simply not worth what we’re paying.
Ironically, just a few days before the June 9th stakeholder’s meeting, NASEM published a report entitled, “The Promise of Assistive Technology to Enhance Activity and Work Participation.” Chapter 5 is devoted to “Selected Hearing Technologies”. It’s an excellent review of the technologies available to and barriers experienced by people with hearing loss. Among its conclusions is the following:
Proper fitting and training are complex but necessary elements of maximizing performance among users of hearing devices. Consumers who work with providers trained in the use of properly prescribed and fitted hearing devices can expect better results than those who use off-the-shelf products.
My Mystery Mail
I paid my $9.75 to the post office to find out what was inside that package. It turned out to be some marketing materials for a cerumen removal product.
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 email@example.com