by Harvey Abrams, PhD.

Harvey Abrams PhD

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

 

It has NOT been a quiet week in Lake Woebegone. Legislation has been introduced in both the Senate and the House of Representatives to permit over-the-counter (OTC) hearing devices to be sold to the public without any requirement for professional involvement. Similar legislation was introduced at the end of the 114th Congress but the session concluded before any action could be taken on the bill.  

 

Into the Congressional Woods

 

The 2017 version of the Over-the-Counter Hearing Aid Act differs from the 2016 version in several respects. Maggie Hassan (D-NH), and Johnny Isakson (R-GA) have been added as cosponsors in addition to its original sponsors, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA).

The current bill requires that the Food and Drug Administration (FDA) provide “reasonable assurances” of the safety and efficacy of OTC hearing aids to include the establishment of appropriate output limits. Another important revision is that the bill now requires the FDA to update and finalize its draft guidance on personal sound amplification products (PSAPs). The 2016 version of the bill called for it to be withdrawn.

In addition, the language in the 2017 bill strengthens the federal preemption provision (i.e., limiting State or local laws in conflict with federal law) that appeared in the 2016 bill by adding a prohibition against the establishment or continuation of “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”.

The language in the house version of the bill, sponsored by Representatives Marsha Blackburn (R-TN) and Joe Kennedy III (D-MA), is very similar to that in the Senate version.

 

Is it Safe for Stakeholders to Walk Through the Woods Alone?

 

If we accept the possibility that some form of this legislation is likely to pass both Houses and be signed into law, the changes that have taken place in the few months between the introduction of the two versions of the bill are moves in a positive direction. The addition of language requiring the FDA to ensure that OTCs meet specific standards of safety and efficacy and to update, rather than withdraw, its guidance on PSAPs are small but meaningful victories for the professional organizations and industry associations who supported these changes.

There is still another battle to fight – and that is to limit the sale and distribution of OTCs to individuals with mild hearing loss, only. As currently conceived, these devices would be made available to those with “mild to moderate hearing loss”.  Notably, in none of the published reports or recommendations has anyone proposed a definition of “mild to moderate” hearing loss. The ends of this continuum represent vastly different degrees of hearing impairment and different approaches to treatment to ensure optimum benefit.

For example, if we use ASHA’s classification system, the OTCs would be appropriate for individuals with hearing losses ranging from 26 dB at one end to 55 dB at the other. The FDA  describes an even wider continuum of hearing losses with mild to moderate categories ranging from 20 dB to 70 dB. Neither ASHA nor FDA, however, define the specific frequencies that should be used to determine these cut-offs.

Assuming, for the sake of illustration, that 2000 Hz is included as part of a 3-frequency PTA at 500, 1000, and 2000 Hz, an individual can have hearing losses exceeding 90 dB at 2000 Hz and still be considered an appropriate OTC candidate according to the proposed legislation and the FDA classification criteria (Figure 1).  

 

Satisfaction in an Outcome Measure Too

 

Another important OTC-related development that occurred in the past couple of weeks was the publication of a randomized controlled trial (Humes et al, 2017) that prospectively compared the effects of an audiology best practices (AB) hearing aid delivery model to an OTC approach.  The results suggested that there were no significant differences between the 2 approaches on 5 of 6 outcomes; the exception being the measure of satisfaction, on which the AB approach yielded a significantly higher mean satisfaction rate than the OTC approach. In addition, those assigned to the AB model were more likely to purchase their hearing aids following completion of the clinical trial than those in the OTC group.

It should be noted that participants in both groups (as well as those assigned to the placebo arm of the study) received baseline audiologic evaluations and the same high-end, commercially-available digital hearing aids.  In addition, 83% of the OTC participants who were undecided about keeping their hearing aids at the end of the initial phase of the trial decided to do so following completion of an additional 4-week follow-up trial during which they received the AB service-delivery model (i.e., probe microphone verification to target, adjustment of MPO and hearing aid orientation).

Satisfaction rates increased among the OTC group after the follow-up trial as well. One could reasonably assume, then, that the professional component of the hearing aid selection and fitting process matters (as does, perhaps, the quality of the device).

 

The FTC is Knocking at the Door

 

With these OTC-related activities as prologue, the Federal Trade Commission (FTC) will be holding a workshop  on April 18th “to examine competition, innovating, and consumer protection issues raised by hearing health and technology, especially hearing aids.” The specific topics to be discussed include:

  • Consumer Information and Search Costs
  • Innovation in Hearing Technology and Treatment
  • Innovation in Hearing Health Care Delivery
  • The Benefits and Costs of Regulation

The agency is also seeking comments from the public and interested parties through May 18th in response to the following questions:

  1. What information about hearing technology and related health care services is available to consumers who may be shopping for these goods and services? How useful do they find this information?
  2. How are hearing aids and other forms of hearing technology commonly distributed and sold? To what extent are new sellers of hearing devices, as well as new methods of distribution and sales, affecting the range of goods, services, and prices available to consumers?
  3. How are innovations in hearing technology – including hearing aids, personal sound amplification products (PSAPs), and other devices and platforms – changing the competitive landscape and expanding the range of viable options to ameliorate hearing loss? What other innovations and developments are on the horizon?
  4. To what extent are hearing aids, PSAPs, or “hearables” interoperable with different adjustment or programming tools, as well as other technologies and communications systems? What standard setting efforts are underway and how might standard setting further competition and innovation (or fail to do so)?
  5. To what extent might existing federal and state regulations be modified or streamlined to better accommodate new technologies and business models, consistent with promoting competition and innovation while meeting legitimate consumer protection objectives?

Fasten your seatbelts; it’s going to be a bumpy ride.

 

References

 

Humes, L.E., Rogers, S.E., Quigley, T.M., et al. (2017). The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. American Journal of Audiology, 26, 53-79.

 

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 at harvey_abrams@starkey.com

Feature image by Ross Land/Getty

Brian Taylor, AuD

by Brian Taylor

“Signal & Noise” is a bimonthly column by Brian Taylor, AuD

Recall the term “good audiology” is loosely defined as a combination of science and art that cannot be duplicated by a computer algorithm. The first two Signal and Noise posts of 2017 were devoted to this concept of “good audiology” and why – even in this era of disruptive technology and service models – it is even more important than ever. 

 

Speech Audiometry Resuscitated

 

This installment of Signal and Noise examines the limitations of the ubiquitous pure tone audiogram as a counseling tool and how the use of one quick speech audiometry procedure can provide important insights into hearing aid expectations and use. As you will recall from your introductory coursework in clinical audiology, speech audiometry – when properly conducted – is an effective way to evaluate the information carrying capacity of the cochlea and remaining auditory pathway.  

The use of one additional low level speech test, described below, allows audiologists to resist the temptation to treat the audiogram, and instead treat the damaged cochlea.

 

Speech Performance-Intensity Functions 

 

Figure 1. Audiogram, cytocochleograms and performance-intensity functions from two temporal bone cases. Described here as Patient A (left) and Patient B (right). From Halpin, C. & Rauch, S. (2009) Clinical implications of a damaged cochlea: Pure tone thresholds vs. information-carrying capacity. Otolaryngology-Head & Neck Surgery. 140, 473-476.

Conducting routine speech audiometry at two intensity levels can be a particularly effective way to explain hearing aid performance differences, especially in patients with mild to moderate, downward sloping hearing loss. This is illustrated in the Figure 1, which was reported by Halpin and Rauch in 2009 (p.474). Notice in the Figure two similar audiograms from two different patients: call them Patient A on the left and Patient B on the right.

If the clinician were to rely on standard tests – the audiogram and speech testing completed at higher intensity levels only, both patients are likely to be fitted and counseled in very similar ways. However, by conducting word recognition at a low and then high intensity level, the potential information carrying limitations of the cochlea can be established in a way that is easy to communicate to patients. 

Specifically, note the results for Patient B on the right side of the Figure 1. These results, shown on the bottom right performance-intensity function, indicate the information carrying capacity for this patient is severely limited – increasing the intensity of the speech does not result in an improvement in word recognition ability.

It is this limitation that cannot be overcome with gain from hearing aids.

 

Using Speech Performance-Intensity Functions to Predict Hearing Aid Benefit

 

Most clinicians conduct speech audiometry at higher levels (see Guthrie & Mackersie, 2009 for details on best practices) as part of a routine diagnostic assessment. But as Halpin and Rauch point out, by adding a low level presentation, the clinician can demonstrate to the patient the potential for improvement from the gain provided by amplification. In their paper, they suggest conducting the procedure at two levels: 40dB HL and 70 dB HL. You could also obtain similar information by using any validated speech test, like the Quick SIN, by presenting a list at a low level and comparing it to the score you obtain at a higher intensity level.

Further, if you are wondering of it is really worth the time to make one more run of 50 words in each ear at a lower intensity level, the authors reported that of 255 cases of individuals with sloping audiograms, like the ones shown in Figure 1, a whopping 81% of cases showed no improvement at the higher intensity level.  

These patients need to know that hearing aids (or any other device that restores audibility) won’t exceed their scores obtained at the higher intensity level obtained with earphones. There is a performance ceiling, uncovered by their performance-intensity function. 

 The bottom of Figure 1 shows the performance-intensity (PI) function for both Patient A (bottom left) and Patient B (bottom right). Note the normal PI function is in bold, while the results for both patients are represented by the dotted line.  The results on the bottom left, which shows a tight match of the normal PI function, indicate the Patient A should perform quite well with hearing aids when audibility is optimized. On the other hand, as shown at the bottom right of the Figure, Patient B is likely to experience significant limitations from amplification even when audibility is optimized. Patient B will, in addition to gain, require technology that markedly improves signal to noise ratio, such as companion microphones or assistive listening devices.

 

Audiologists As Experts in a Time of Second Opinions

 

The report from Halpin & Rauch is another example of the need for “good audiology” — a clinician who can quickly and accurately conduct a validated test and use this information to make better decisions for patients. In the case of those 81% that show no improvement in performance at the higher intensity level, it is up to steadfast clinician to temper expectations, explore alternative technology that maximizes the signal-to noise ratio and not oversell the benefits of hearing aids.

As more and more patients purchase PSAPs, over-the-counter devices, and eventually, self-fitting hearing aids, it is likely clinicians will see some of these patients for a second opinion – patients that are likely to have similar performance-intensity curves like the one on the bottom right in the Figure below and are below par benefit than expected with their devices.  The use of simple procedures, like presenting words at a low and a high level and plotting on the performance-intensity function, help position clinicians as experts, unbound from their hearing aid technology, willing to use data to make clear decisions for patients.

 

References

 

Guthrie LA & Mackersie CL. A comparison of presentation levels to maximize word recognition scores. J Am Acad Audiol. 2009 Jun;20(6):381-90.

Halpin C & Rauch SD. Clinical implications of a damaged cochlea: pure tone thresholds vs information-carrying capacity. Otolaryngol Head Neck Surg. 2009 Apr;140(4):473-6. doi: 10.1016/j.otohns.2008.12.021.

 

Brian Taylor, AuD, is audiology advisor for the Fuel Medical Group and contractor for Bose.  He continues to serve as Editor of Audiology Practices, the quarterly publication of the Academy of Doctors of Audiology. During the first fifteen years of his career, he practiced clinical audiology in both medical and retail settings. Since 2005, Dr. Taylor has held a variety of leadership & management positions within the hearing aid industry in both the United States and Europe. He has published over 50 articles and book chapters on topics related to hearing aids, diagnostic audiology and business management. Brian has authored three text books:  Fitting and Dispensing Hearing Aids(co-authored with Gus Mueller), Consultative Selling Skills for Audiologists, and Quality in Audiology: Design & Implementation of the Patient Experience.  His latest book, Marketing in an Audiology Practice, was published in March, 2015.  Brian lives in Golden Valley, MN with his wife and three sons.  He can be reached at brian.taylor.aud@gmail.com or brian.taylor@turtlebeach.com.

feature image courtesy of Cambridge in Color (edit)