This week’s Hearing International discusses an issue that likely will be upon us rather soon in the United States.  In the United States, a large discrepancy exists between the number of people who could benefit from hearing aids and those who actually wear them. Close to 29 million U.S. adults could benefit from using hearing aids, according to National Institute on Deafness and other Communication Disorders (NIDCD). Yet, among adults aged 70 and older with hearing loss who could benefit from wearing hearing aids, fewer than one in three (30%) have ever used them. Even fewer adults aged 20-69 (approximately 16%) who could benefit have ever used them.  While a complex topic that deserves substantial discussion, there are some that feel the cause of this issue is the cost of these products and government efforts are being initiated to reduce the cost of hearing aids.  Some of the uninformed believe that these products should simply be available over-the-counter with no expertise offered as part of their dispensation.

Republican Senator Charles Ernest “Chuck” Grassley, the senior United States Senator from Iowa and Elizabeth Warren, a Democratic Senator from Massachusetts have introduced a bill into the US Senate (S. 9).  Their legislation would make permanent the policy change announced by the Food and Drug Administration (FDA) December 12, 2016 to no longer require a medical examination that has long been required for the use of hearing aids as well as put real hearing aids into drug stores.  While the sunset of the medical examination requirement has long been advocated by audiology organizations and those that support the hearing impaired, Grassley’s statement, “It’s bewildering that a consumer can buy non-prescription reading glasses over the counter but relatively simple hearing aids are not available for sale off the shelf.”  If they would have actually checked, there are already instruments that satisfy that market in drug stores, radio waves, television ads, and online called Personal Sound Amplification Product Systems (PSAPS).  These products are designed for simple hearing losses that might be assisted by a cheap, simple amplification devices.  Of course, they are not nearly as sophisticated as today highest technology hearing aids, but they are directed at the same type of individual that would purchase reading glasses over-the-counter (OTC). What Senator Grassley and/or Elizabeth Warren’s advisors have not told him is that sensori-neural hearing loss is not nearly the same as the simple correction offered by reading glasses.  While most vision difficulties are corrected by refractive corrective lenses, such as OTC reading glasses, there some patients with macular degeneration and astigmatism and other visual disorders that cannot be helped with simple corrective lenses.  So for many there are no glasses that will correct their vision but they are a relative minority compared to those that use these OTC reading glasses.  The correction of hearing disorders is quite different.  Sensori-neural hearing loss could loosely be called macular degeneration of hearing and it makes up most of the hearing impaired that will use hearing aids.  Most hearing impaired patients suffer from sensori-neural hearing loss.  For those few patients where a simple amplifier will treat their hearing impairment, PSAPS are already available OTC.  For the greater percentage of hearing impaired patients with sensori-neural losses,, a professional is required to assess the variables of the hearing loss, prescribe the appropriate device, insure that it works for the life of the product as well as take care of earwax and other complicating issues.  While audiologists, patients, and their physicians will welcome the discontinuation of the annoying medical examination requirement, the thought that real hearing aids in drug stores and other such places will increase those using the devices is probably wishful thinking.  More likely, it will increase what audiologists call the “Dresser Drawer Syndrome”,  or those hearing devices sitting drawers at home that are unused and actually increasing the overall costs to the patient.   Success of a hearing device is not just the device itself as it is with reading glasses, there is huge psychological overlay with hearing loss that is not there with a vision problem.  Audiologists refer to this issue as stigma, long an issue with hearing devices that have disappeared from the use glasses.  So, Senators Grassley and Warren, this is what happens when those with no background working with hearing impaired patients, stick their nose into the middle of an issue when they really do not understand.  

Where’s the Evidence that Hearing Professionals do it better?

 As clinicians, everyday we see anecdotal benefit from our patients in their use of properly prescribed and fit amplification products. While we see this benefit each and every day in clinic, there has been a lack of research that has led to the type of statements offered by Senator Grassley and others.  There are so many variables in this the type of research that need to be covered prove it is best to see a professional for hearing aids that it has long eluded audiology in their quest to prove their success.  National Institute on Deafness and Other Communication Disorders (NIDCD) has prioritized funding research in areas that could lead to the improvement of hearing health care for adults with mild-to-moderate hearing loss that will enhance the accessibility and affordability of hearing health care.   In an effort to seriously look at the benefits of audiology prescribed and fit hearing devices versus those obtained OTC, researchers at Indiana University (IU) – Bloomington with funding support from the  have begun to seriously review this issue.  Their recent study sought to compare patient outcomes when hearing aids are delivered via an audiology “best practices” model compared with an “over-the-counter”  model.  This study was the first-ever placebo-controlled, double-blind, randomized clinical trial of hearing aid outcomes by researchers at the University of Indiana – Bloomington.  The IU research team, led by Dr. Larry Humes- a distinguished professor of Audiology within the Department of Speech and Hearing Sciences- found that “The research findings provide firm evidence that hearing aids do, in fact, provide significant benefit to older adults,” and “This is important because, even though millions of Americans have hearing loss, there has been an absence of rigorous clinical research that has demonstrated clear benefits provided by hearing aids to older adults. Consequently, the U.S. Preventive Services Task Force has not been able to support widespread hearing screening for adults over age 50. This study, along with others to follow, will help establish the evidence base needed to foster better hearing health care for many older Americans.”

The study looked at 154 adults ages 55-79 years with mild-to-moderate hearing loss. All participants received the same high-end digital mini hearing aids fitted in both ears. Subjects were divided into three groups. One (the best practices group) received “best practices” services from audiologists that included professional fitting and counseling; one (the OTC group) received no professional fitting by an audiologist and selected their own pre-programmed hearing aids; and the placebo group that received a professional fitting but used a hearing that was programmed to provide no acoustical benefitResearchers found that hearing aids are effective in older adults for both the audiology best practices model and the OTC model. There were no significant differences in outcome between these two service-delivery approaches for five of the six outcome measures, but the OTC group fared somewhat worse when it came to satisfaction with their hearing aids. Fewer OTC participants were also likely to purchase their hearing aids after the trial (55% for the OTC group vs. 81% for the best practices group, with 36% for the placebo group). Following the initial 6-week trial, both the OTC and placebo groups were offered hearing aids under the best practices model. Satisfaction significantly increased for patients in both groups who chose to continue under audiologist care, and more participants opted to purchase their hearing aids after this continued period of care than after the initial trial.

“More studies are needed to assess the generalization of the results obtained here to other patient populations, other devices, and other models of OTC service delivery,” said Humes, adding, “All of the devices used in this study were of high quality as opposed to the simpler, less expensive devices many associate with an OTC model. Also, all patients received a complete audiologic evaluation prior to treatment which is another potential difference from some OTC models under consideration. These factors could impact patient outcomes. However, the results of this study should serve as a yardstick for comparing outcomes of future hearing aid studies.”

The message in this study to those that are considering OTC hearing aid models of delivery is that those that were counseled, fit and followed using the best practices model were 27% more likely to purchase the hearing aids that they were trying. It appears that hearing aids in an OTC environment are setting patients up to fail in their use. 

Senators Grassley and Warren….Are you listening?

 

References:

Humes, L., Rogers, L., Quigley, T., Main, A., Kinney, D. & Herring, C. (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, Retrieved March 7, 2017.

 

 

 

To those of us that have had the opportunity to study contemporary hearing, deafness, and its treatment, the products discussed below in this post seem, at first glance, to be quackery.  Initial appearances suggest that these products were a con man’s idea of how to sell a device with no value to the hearing impaired. When considering the times and the prevalence of various hearing disorders, deafness was quite different than today and may offer a completely different rationale for these devices.  

 

Consider the Prevalence of Otosclerosis in 1900 

 

The American Academy of Otolaryngology/Head Neck Surgery (AAO/HNS) (2017) indicates that otosclerosis is the formation of spongy bone about the stapes and the oval window of the ear, causing progressive deafness.  While this genetic disorder affects about 10% of adult Caucasians, it is less common in Japanese and South American populations and is rare in African Americans.

The video describes the disease as a progressive disorder that affects mostly women although it does affect men as well. [Click on the picture for a description of otosclerosis]  The gradual deafness that begins in one ear and slowly causes hearing loss in the other ear with the progression of the hearing loss over a lifetime.

Sakihara, Christensen, and Parving (1999) found that the cohorts for 1910 to 1919 and 1920 to 1929 had basically the same incidence of otosclerosis as currently found in Caucasians.   It was known then that the hearing loss was caused by the stapes being dampened by the spongy bone within the oval window, impeding the sound transmission to the cochlea.

In the hands of a capable 2017 otologic surgeon, otosclerosis is about 85% curable with a stapendectomy operation.  In 1900, however, it was quite a different story.  Tod (1909) describes the state of surgery for otosclerosis of his time as a mobilization procedure.  The goal was to mobilize the stapes and restore hearing once again.  Dr. Tod describes the surgical results in 1909 as “difficult to foretell as it is chiefly dependent upon the extent of the adhesions already existing within the tympanic cavity and on the mobility of the stapes within the fenestra ovalis [oval window].  If the latter is already fixed, then improvement is impossible.  If, however, the adhesions are limited, a better result may be obtained by this method than by pneumo-massage and inflation.  The surgeon must be guided by the extent and duration of the improvement as to how long to continue treatment.  Unfortunately, relapses are not uncommon, though temporary benefit may be obtained.” 

If the surgery was declined, or considered not beneficial, then massage was conducted as a last resort “in the hope of obtaining some improvement in hearing.”  

Thus, according to Tod, surgery for otosclerosis was a mobilization to achieve at least a temporary respite from hearing loss; however, recurrence of hearing loss was not unlikely as the spongy bone grew back.  So why not consider the massaging approach?  Theoretically, it should work to move the eardrum, then the ossicles, and maybe the stapes bone that was stuck in the oval window. 

 

But If No Surgery…..Then What?

 

In 1900, hospitals were a place to go and die, not necessarily to get better, or restore hearing.  Thus, there were lots of “out patient” remedies for most everything, including some strange elixirs and devices thought to restore most anything.  For example, consider that radium had just been discovered in 1898 and by the early 1900s, radium was considered to be much more valuable than either gold or platinum. Radium or radon laced water was called “liquid sunshine” because it was believed to be a magical elixir that could promote health and prolong life by rejuvenating effects that provided a host of widespread benefits.  Given the views and limited knowledge of the times, the idea of massaging the eardrum and thus, the auditory ossicles for otosclerosis probably had some merit. 

It is well documented that Miller Reese Hutchinson first fit the Queen of England with his Akuophone device in 1902. Ear massagers debuted right about this time and appear to be the brainchild of Hutchinson.  According to Bauman (2017) of the Hearing Aid Museum, “at that time he was hobnobbing with the deaf royals of Europe.  And, remember that several of them were suffering from the results of otosclerosis.”  Of course, the royals of Europe had intermarried and perhaps this was a factor in why otosclerosis was a problem for many of them. 

It is Bauman’s contention that Hutchinson was probably trying to fix Alexandria’s hearing by inventing one of the very first vibration devices, Massacon Ear Treatment Device.  Originally called the “Akou-Massage”, the Massacon was a rather ingenious, non-invasive way to treat deafness caused by otosclerosis.  The treatment was to create a loud sound vibration through the earphone held against the patient’s ear.  Theoretically, the Massacon would cause severe vibration to the eardrum and, consequently, auditory ossicles as a means of loosening them in the oval window.  While this Massacon was made for the use of physicians and not as a home treatment for hearing loss, it produced ear-damaging levels of sound as its softest sound was about 120 dB and the volume went up from there.  Bauman feels that this was not necessarily a quack device, but a sincere attempt to create a device that would cure otosclerosis. 

The Massacon was just the beginning of devices specifically designed to work for otosclerosis.  The rare instrument to the left was used by Berlin physicians in the early twentieth century.  The patient would put on the stethoscope and listen to various sound frequencies played through a battery powered violin. This device complements the violin vibraphone above since it employed a violin bow to be used for the diagnosis of various forms of hearing impairment. 

Then there was the Dr. Guy Clifford Powell’s vibratory therapy or the Ardente “Aurashelle” Ear Treatment Device (Ear Vibrator) a 1930s device from England that was also to vibrate the ossicles.  The intent of the Aurashelle seems to have been to cause severe vibration to the eardrum and consequently the ossicles but the loud buzzing of the device was enough to cause sensorineural hearing loss and tinnitus.

 

There are probably a hundred other treatments that either never made it to prime time or have been lost over the years.  My conclusion is that, while these were feeble attempts to cure a hearing loss without much research, most were honest attempts at cures based upon the knowledge of the time.

 

References:

American Academy of Otolaryngology Head Neck Surgery (2017). Otosclerosis.  Retrieved February 27, 2017.

Bauman, N. (2017a).  The Massacon.  The Center for Hearing Help, Hearing Aid Museum.  Retrieved February 28, 2017.

Bauman, N. (2017b).  Oticon.  The Center for Hearing Help, Hearing Aid Museum.  Retrieved February 28, 2017.

Sikihara, Y., Christensen, B. & Parving, A. (1999). Prevelence of hereditry hearing loss in adults.  Scandinavian Audiology, 28(1), pp. 39-46.  Retrieved February 27, 2017.

Tod, H. (1909). Section III. Operations Upon the Ear, Chapter III, Operations Upon the Tympanic Membrane and Within the Tympanic Cavity.  In Burghard, FF (Ed) A System of Operative Surgery.  Oxford Medical Publications. pp. 350. Retrieved February 27, 2017.

Traynor, R. (2015).  The road to the first portable electronic hearing aid and beyond.  Hearing Health Matters.  Retrieved February 28, 2017.

Videos:

Varakala, V. (2017).  Otosclerosis.  You Tube.com Retrieved February 27, 2017.