Both PCAST (President’s Council of Advisors on Science and Technology) and NAS (National Academies of Sciences) have recommended that OTC hearing aid (over-the-counter) sales be permitted for mild-to-moderate hearing losses. Additionally, the SB 9 Over-the-Counter Hearing Aid Act of 2016 introduced by Senators Warren and Grassley Senate Bill further requires that the FDA (Food and Drug Administration) remove the “normal hearing” restriction on Personal Sound Amplifier Products (PSAPs), and would override the restrictions in all 50 states.* (correction at end).

With the decision directing the FDA to allow hearing aids to be available via OTC sales, the reality is that many of the instruments currently identified as PSAPs (personal sound amplification products) can also legitimately be identified as hearing aids. That identification is essentially up to the producer of the product.  Or, as some are now doing, producing exactly the same product, but labeling one as a hearing aid, and the other as a PSAP, obviously looking at different markets for the same product. 

Of course, final FDA procedures relative to performance standards and labeling of OTC devices are not yet defined, but are suspected to consider recommendations made by the Consumer Technology Association PSAP Quality Standard Committee, which is suggesting a number of restrictions for PSAPs greater than required of hearing aids1.

  

Objection Expressed with OTC Hearing Aid Sales – Dissatisfied Users

Many hearing professionals have expressed concerns that OTC hearing aid sales will result in dissatisfied users because:

  1. The instruments are not professionally fitted
  2. An audiogram is necessary
  3. OTC-sold devices (previously defined as PSAPs) are of poor quality and will not meet the needs of the hearing impaired, and
  4. Poor experiences by the purchaser will discourage them from seeking additional assistance and purchasing a “real” hearing aid
  5. A Universal, basic hearing aid cannot manage all hearing losses

  

What follows is a discussion of the first of the five concerns (listed above) that hearing professionals have argued would result in dissatisfied users of OTC products.

  

The Instruments Will Not Be Professionally Fitted

 

What is a professionally-fitted hearing aid? 

Is this a fitting made only by an audiologist?  Does this include both audiologists and hearing aid dispensers, and what about otolaryngologists?  Does this require a state dispensing license, and if so, what does the license guarantee?  For example, an individual can be state licensed as an audiologist, which in many states allows them to legally sell hearing aids, but may have no practical knowledge and/or interest in hearing aids.  If such a person fitted a hearing aid, would it be “professionally fitted?”

It would seem difficult to exclude otolaryngologists, even if they have no hearing aid fitting experience or license, because it could easily be argued that they are the ultimate hearing professional.

It is noteworthy that often comments by hearing professionals citing personal experience stories about poorly-fitted OTC or other non-traditional sales, state this as being related to unqualified individuals, or to no individual performing the fitting.  This casts light on their unstated assumptions then, that all fittings by hearing professionals are uncontested.  If this were only the case.  Unfortunately, there is no factual agreement as to when a hearing aid fitting is optimal.  If there were, such discussions would be more meaningful.  In truth, the final decisions as to whether hearing aids are useful and worthy of being worn, are relegated to the users, not to anyone else.

As a result, it may be easy and sound reasonable to say that a hearing aid should be fitted professionally, but it appears that this statement will involve a serious discussion of what/who this involves.

Additionally, recent comments make it clear that the number of “professionally qualified” individuals is not growing at a rate to keep up with the demand for hearing amplification needs2,3

  

Does having a hearing professional involved increase consumer purchasing decisions?

The action of visiting a hearing professional for hearing loss solutions is often cited as of major importance in the selection and fitting of hearing aids.  To this end, suggestions and attempts have been made over the years for audiologists to actively provide potential users information about the importance of hearing and visiting hearing professionals for proper evaluation, counseling, and fitting to make consumers more knowledgeable purchasers of hearing aids.

The question to be asked is, what is the impact of visiting an audiologist?

 

Role of the Hearing Professional – Consumer Action

A recent report might provide some insight into this issue.  A 2015 survey conducted by the Northwestern University’s Kellogg School of Management’s Experiential Learning Initiative, sheds some light on how successful such promotional efforts may have been5.  They surveyed 328 persons over 55 years of age, who were perceived or diagnosed as having a hearing loss, and who were interested in finding a solution for their loss.  The study provided information as to how effective the role of the hearing professional was from a consumer point of view.

 

HA Professional Contact

Figure 1. In a survey of 328 individuals who were perceived or diagnosed as having a hearing loss, and who were interested in finding a solution for their loss, 55% had sought the advice of a hearing professional, whereas 45% had not4.

Of the 328 persons involved in the Kellogg/NU survey, fifty-five percent had seen a hearing professional, and forty-five percent had not (Figure 1).  Keep in mind that this was a survey of individuals perceived or diagnosed as having hearing loss and had an interest in doing something about it.

 

 

 

 

 

Does Contact with a Hearing Professional Influence Consumers’ Decisions to Purchase Hearing Aids?

Frequent rhetoric espouses the importance of seeing a hearing professional when it comes to amplification.  But, what impact does this have on the consumer?  Up to this point, if this has been measured, it seems to be escaping documented published commentary.

However, the Kellogg/NU survey provides data on the success rate of hearing aid purchase following a hearing professional visit (Figure 2).  Forty-five percent (81 individuals) purchased hearing aids resulting from their professional visit, 55% (99) did not.  Of the remainder of patients who reported that they were interested in finding a solution, 45% (81) did not seek the counsel of a hearing professional.

 Logical questions are:

  • why did only 45% purchase hearing aids even after having been evaluated and counseled by a hearing professional?, and
  • why did 55% who then were interested in finding a solution not seek the counsel of a hearing professional if that is seen as the “enlightened” way?

Figure 2. Hearing aid purchase performance of individuals who saw a hearing professional. (Kellogg/NU Survey, 2015. n=328).

  

Reasons for Not Purchasing Hearing Aids After Seeing Hearing Professional

Perhaps the real reason may not be known, but a factor that weighed heavily in the decision not to purchase, even after having been seen and counseled by a hearing professional, related to cost.  This seems to be somewhat at odds with other published information expressing that cost is not a primary reason for non-purchase5.  Perhaps the result differences reflect the way the question has been asked, and reported.  In the Kellogg/NU survey, cost was listed as the number one reason (60%), but 80% of the patients cited cost as being too expensive (Figure 3).  It appears that cost continues to be a reason for non-purchase, even when presented from a hearing professional office.

Figure 3. Cost was cited as the number 1 reason by those who saw a hearing professional and decided not to purchase hearing aids (60%). Overall, 80% commented that hearing aids were too expensive. So, seeing a hearing professional and being counseled by such, was not sufficient cause for more than half (55%) to not purchase.

  

Why did 55% who then were interested in finding a solution not seek the counsel of a hearing professional if that is seen as the “enlightened” way?  This post cannot provide the answer to that question.  However, it might be speculated that some individuals with a hearing loss are not prepared to make a commitment with a capital “C,” (primarily as seen to be associated with professional services) but might possibly try making a commitment with a small “c,” (OTC) especially if they have doubts about whether they want to try amplification or not.  They may see the risk factor between the two as something they are able to manage.

Following posts will continue this discussion, commenting on the additional four objections listed at the start of this post, namely:

  1. An audiogram is necessary
  2. OTC-sold devices (previously defined as PSAPs) are of poor quality and will not meet the needs of the hearing impaired, and
  3. Poor experiences by the purchaser will discourage them from seeking additional assistance and purchasing a “real” hearing aid.
  4. A Universal, basic hearing aid cannot manage all hearing losses

 

References

  1. Killion, MC. and Gudmundsen, G. (2016).  New CTA PSAP quality standard. ADA Audacity Conference, San Diego, CA, 11/12/2016.
  2. Freeman, B and Windmill, I. (2017).  Demand an Audiologist, but will there be one available?  February 7, 2017. http://hearinghealthmatters.org/hearingeconomics/2017/demand-audiologist-will-one-available/.
  3. Hosford-Dunn, H. (2017).  Supply and Demand in the Audiology Labor Market, Part 4, February 21, 2017  http://hearinghealthmatters.org/hearingeconomics/2017/supply-and-demand-of-audiologists-part-4/.
  1. Anderson. (2015).  Market Research Study commissioned through Northwestern University’s Kellogg School of Management’s Experiential Learning Initiative, 2015.
  2. Valente, M., and Amlani, A.M. (2017).  Cost as a barrier for hearing aid adoption.  American Medical Association.  http://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2627924.

 

* Clarification and Correction

This week’s post opened with the following statement:

“Additionally, the SB 9 Over-the-Counter Hearing Aid Act of 2016 introduced by Senators Warren and Grassley Senate Bill further requires that the FDA (Food and Drug Administration) remove the “normal hearing” restriction on Personal Sound Amplifier Products (PSAPs), and would override the restrictions in all 50 states.”  This incorrectly makes two statements that are not correct, and what follows corrects this statement.  We apologize for this error, having used the information from a previous post as a general background.  HHTM

 

What is?

What is a HA (hearing aid) and what is a PSAP?

 

  1. FDA Guidance = 2013

FDA to:

  1. Review Guidance and finalize in 2014.
  2. Clarify difference between a hearing aid and PSAP

                  Both for OTC and otherwise

            Normal hearing restriction – nothing said about restricting this in the 2013 guidance.

 

The Language

(c) New guidance issued. —Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.

 

 

Action Re State Regulations

 

  1. No state hearing aid regulations are going to be overridden that are not in the OTC category.
  2. FDA will enforce whatever definition PSAP turns out to be. 
  3. The language of the bill is very narrowly written to apply ONLY to a new category of OTC hearing aids.
  • That is, states cannot require that consumers buy an OTC hearing aid from a licensed professional. 
  • They may, however, still require that consumers buy other hearing aids from a licensed professional. 
  1. Only those laws that prevent OTC sales will be preempted, and only with respect to OTC hearing aids that are approved by FDA. 
  2. Generally applicable consumer protections are unaffected, such as warranty provisions and return periods.
  3. State licensure laws will still be applicable to sales of traditional hearing aids.

 

 

The Language

(4) EFFECT ON STATE LAW.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically applicable to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(p) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

Accommodating the OTC Hearing Aid Discussion: Hearing Screening in the Absence of Audiometry – Part 2

 

by Wayne M. Garrison* and Joseph H. Bochner**


This is the second of a two-part series on an evaluated option to hearing level identification to fit OTC hearing aids in the absence of audiometry.  Part 1 introduced an online hearing level identification test, the NSRT (NTID Speech Recognition Test)1 that could be used to circumvent the belief by some that a pure-tone audiogram is critical to any hearing aid fitting, much less for OTC hearing aid sales. Data obtained from the NSRT® testing experience are used to construct a pseudo audiogram. We report that, when predicted hearing thresholds are compared with conventional, clinical pure-tone measures, the sensitivity and specificity of the NSRT® screening measure have been found to be 95% and 87%, respectively; diagnostic accuracy is 91%2These statistics reinforce the argument for OTC hearing aid sales suggesting that, in addition to self-fitting, self-assessment may be a viable way to manage the market of those individuals not served by current audiological practice.

The use of the term “hearing screening” in this article is not to be confused with hearing screening that uses pure-tone signals.

 

Self-Administered Automated Speech-Based Hearing Screening Test (NSRT®)

Information reports and interpretation resulting from NSRT self-evaluation are provided in this post.  Readers are encouraged to take this online test at https://apps.ntid.rit.edu/NSRT/ to more fully understand and appreciate this self-test of hearing.


Output Displays of the Online Screening

After completing an NSRT® adaptive testing session, respondents have the option to view a variety of tabular/graphical displays illustrating their hearing screening results.  Before any testing results are provided, however, NSRT® data are subjected to a statistical, “plausibility” analysis. The overwhelming majority of test records examined at this point have been found to be valid.  In a small number of cases, however, we have observed enough “noise” within a test record to preclude the output of screening results, insofar as the accuracy of these same results is questionable. Questionable test records are generally the result of carelessness, inattention or otherwise unintended human behavior during a testing session.  Individuals whose test records are flagged as questionable are invited to retake the test.

The simplest of the displays that can be output following a hearing screening test is shown in Figure 1. For many individuals, this simple summary of their performance on the screening measure will be sufficient.  Moving from left to right across the tabs shown moves the respondent to other diagnostic displays.

Figure 1. Simple text output.

The respondent’s hearing screening test score expressed on a scale that extends from 0 – 100 is illustrated in Figure 2. The NSRT® score corresponds roughly to the percentage of speech that one is able to recognize in everyday listening situations. A confidence interval associated with the score is also shown. It represents the range of scores within which we would expect to find one’s “true” NSRT® score 95% of the time on repeated testing, under the same testing circumstances. The NSRT® score may be considered a functional measure of overall hearing sensitivity.  Scores obtained in noise will be lower than those obtained in quiet. Note, however, that the NSRT® is only one piece of information that is used in assessing a respondent’s overall level of hearing sensitivity.

Figure 2. Hearing screening result expressed in terms of speech understanding.

A screenshot of the tabular display available to respondents that statistically combines the information available via the NSRT® testing experience with other self-report data (elaborated at the left of the screen capture) to produce an audiogram (for the better ear), is shown in Figure 3. This pseudo audiogram has been found to conform closely to the audiogram that would be obtained under more controlled, clinical conditions. The NSRT® application does not currently provide threshold data for left and right ears separately since the auditory stimuli usually are delivered to both ears. The next version of the NSRT will allow the user to test each ear separately.

Figure 3. Hearing for speech vs. pure-tone testing connection.

In the “Application to Speech Sounds” tab, we use the NSRT® score in quiet to illustrate the probability that a respondent is able to recognize specific phonetic categories of speech. The “History” tab enables respondents who have tested on more than one occasion or under different testing conditions (i.e., quiet vs. noise) to compare/contrast their pseudo audiograms in graphical format. 


Concluding Comments

In its 2015 report, the President’s Council of Advisors on Science and Technology support the claim that hearing loss in an aging population is now a “substantial national problem,” citing cost as the largest barrier to hearing technology access by individuals who could benefit from amplification, simultaneously advocating changes in FDA regulations that include disruptive improvements in both the assessment and treatment of hearing loss. 

On the treatment side of the argument, the OTC Hearing Aid Act of 2017 is now pending legislative action. 

On the assessment side of the argument, R/D efforts described herein suggest that self-testing may also hold a place in managing the market of those individuals who are not otherwise served by professionals. 

Does the move to self-assessment and OTC hearing aid sales diminish the role of audiologists in the delivery of hearing healthcare?  Not at all!  It actually sharpens and focuses their work with individuals who fall outside the range of mild to moderate hearing loss. 

We invite commentary on our work.


References

  1. Bochner, J. H., Garrison, W. M. and Doherty, K. A. (2015). The NTID Speech Recognition Test:  NSRT®. International Journal of Audiology, 54, 490-498.
  2. Garrison, W. M. and Bochner, J. H. (2015). Applications of the NTID Speech Recognition Test (NSRT®). International Journal of Audiology, 54, 828-837.

 

*Dr. Wayne Garrison is a Research Professor at the National Technical Institute for the Deaf on the Rochester Institute of Technology campus in Rochester, New York.  He is a psychologist by training, with a broad range of R/D experience in statistics, psychometrics and software design.

**Joe Bochner is a professor and department chair at RIT/NTID.  He has been involved in the language sciences, deafness and higher education for four decades, conducting research on the acquisition of English language and literacy skills, speech perception and production, and American Sign Language.