Tele-audiology Offers Great Promise in Reaching Underserved People Globally

By De Wet Swanepoel, James W. Hall, and Leigh Biagio

Editor’s Note: This post, first published on August 23, 2011, ended with a hearkening of the future that is becoming a reality for audiology services as we enter 2017.  It bears republication as a reminder of the thinking and technology in place six years ago.
“In light of the global shortage of hearing health professionals and the overwhelming need for hearing care, tele-audiology may be the most likely way to make a significant impact on global hearing health care delivery.”

Audiological interventions for patients of any age with hearing loss have demonstrated the potential to dramatically alter life course with improved outcomes in language, academic, and vocational achievement as well as far-reaching improvements in socio-emotional wellbeing and quality of life.
According to the World Health Organization (WHO), there are approximately 300 million people in the world who could benefit from hearing health services. Unfortunately, more than 80% of these individuals live in regions where hearing health care services are virtually non-existent or inaccessible to all but a few. In Africa, for example, only two of the 48 countries on the continent of almost 1 billion people offer tertiary professional training in audiology.

This is indicative of the dearth of audiological services that currently exist, and it points to the need to consider alternative strategies to reach patients. The recently developed field of tele-audiology has the potential to help bridge the enormous gap between the demand for hearing care and the available supply.
 

WHAT IS TELE-AUDIOLOGY?

Telehealth is a system of delivering health care in which the provider and the patient are separated by distance. Telehealth services can be provided by two methods. One is synchronously, where the patient and the professional interact in real time through the use of information and communication technology. Or, services may be delivered asynchronously, with information being shared in a store-and-forward model.

Both methods may be incorporated into a hybrid model that relies on synchronous and asynchronous components interacting for maximal efficiency. A recent review of the telehealth literature pertaining to audiology reveals that both models have been used for various audiological functions, including screening, diagnosis, and intervention (Swanepoel DT, Hall JW: “A systematic review of telehealth applications in audiology.” In Telemedicine and e-Health 2010;16(2):181-200).
 

HOW A TELE-AUDIOLOGY CLINIC CAN OPERATE

The first tele-audiology clinic in Africa was started in 2010 as a collaborative project between the University of Pretoria, GeoAxon, and Witkoppen Health and Welfare Centre. It is situated in a primary health care clinic serving an underserved population with a high prevalence of HIV/AIDS and tuberculosis.

The clinic’s daily operation is managed by a trained tele-audiology facilitator. Patients are assessed with diagnostic air- and bone-conduction audiometry.An automated testing sequence is used, and results are uploaded onto a secure server. This allows remotely located audiologists to interpret the audiogram findings. If the results raise questions, a synchronous test is scheduled in which the audiologist takes remote control of the equipment, reinstructs the patient, and tests him or her manually.

The telemedicine-enabled audiometer employed at the clinic is produced by GeoAxon and has unique features suitable for assessments in underserved populations using information and communication technology. The KUDUwave audiometer (Type 2 clinical audiometer) is computer-operated and USB-powered with its hardware encased in the two circumaural earcups. This means the device is fully mobile, which is important for testing in remote areas where services may have to be provided at many sites.

The major obstacle to effective mobile diagnostic audiometry is ensuring that ambient noise levels are sufficiently low to allow for reliable testing. Sound booths are too expensive and unavailable in many developing countries. Those that are available are usually not mobile, which restricts services to a specific location.

The KUDUwave audiometer has two important features that allow it to be used compliantly outside a soundproof booth, as is the case at this tele-audiology clinic. First, the device offers significant attenuation through the use of insert earphones covered by circumaural earphones. Importantly, however, it also actively monitors the environmental noise for compliance by microphones on the circumaural ear cups.

The ambient noise levels are continuously monitored across 1/3-octave bands to ensure that testing is done within permissible ambient noise levels. If these levels are exceeded, the test can be stopped temporarily. Once thresholds are documented, the noise levels at these levels are also stored. Quality control features like these allow for reliable testing in remote areas.

While the pilot phase of this project is almost complete, the formal evaluation phase has not yet begun. However, initial results have been very positive and demonstrate that diagnostic audiological services can be provided at a primary health care level in remote areas within a hybrid telehealth service-delivery model.

Video-otoscopy has also been included as part of the evaluation phase. It is conducted by the facilitator, who is trained to take pictures of the ear canal and tympanic membrane. These can then be evaluated in a store-and-forward manner by ENTs and audiologists. Future phases of this project will include the evaluation of remote hearing aid fittings using non-custom earmold options.
 

LOOKING FORWARD

Information and communication technology combined with the technical nature of audiological screening, diagnosis, and intervention makes audiology uniquely suited to provide a full range of services remotely. The field of hearing health can capitalize on the exponential growth in information and telecommunication networks in the developing world to reach populations that are currently without any services.

In light of the global shortage of hearing health professionals and the overwhelming need for hearing care, tele-audiology may be the most likely way to make a significant impact on global hearing health care delivery.

FDA Eliminates Hearing Aid Medical Clearance Regulation – Effective Immediately

By Brian Taylor

WASHINGTON, D.C. — Today during the National Academies of Science, Engineering and Medicine Dissemination Meeting, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, Eric Mann, Chief, Ear, Nose and Throat Devices Branch of the U.S. Food & Drug Administration (FDA) announced that it does not intend to enforce the requirement for adults to obtain a medical evaluation before obtaining most hearing aids. This guidance is effective immediately.  As many know, the majority of individuals waive this requirement prior to purchasing hearing aids.

In addition, the FDA announced its continued commitment to the possible creation of a category of over-the-counter (OTC) hearing aids. The rapidly aging population,  and both the low uptake & high retail price of hearing aids were cited by the FDA as reasons new, lower cost products  are needed. These types are new products are thought by the FDA and others to create more consumer choice and foster greater competition and innovative among manufacturers. The FDA per today’s press release reaffirmed it is committed to seeking additional public input before proposing a new category of OTC devices.

Robert Califf, MD

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourages innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf in the FDA press release.  
 
“The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”  –Robert Califf, FDA Commissioner
 
In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) issued recommendations intended to facilitate hearing aid device innovation, and improve affordability and patient access. And, this past June the National Academies of Sciences, Engineering and Medicine (NAS) published a comprehensive study examining the affordability and accessibility of hearing care for adults.

Over the past 15 months two organizations, PCAST and NAS, have cited FDA regulations regarding conditions for sale as a potential barrier to availability and accessibility of hearing aids. Both groups concluded that the regulation was providing little to no meaningful benefit to patients. As hearing care professionals know, since the early 1970s – and until today – the FDA regulation required all prospective hearing aid users obtained a medical evaluation by a licensed physician (or sign a waiver if 18 or older) prior to purchasing hearing aids.

According to today’s FDA press release, under the new guidance, the FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18. Under the FDA’s hearing aid regulations, hearing aid labeling must include information about medical conditions that should be evaluated by a licensed physician. In addition, the FDA requires that information and instructions about hearing aids be provided to consumers before any purchase from a licensed audiologist or hearing aid dispenser.
 

Guidance Effective Immediately

Since today’s guidance is “Immediately in Effect,” it is implemented without prior public comment “because it presents a less burdensome policy that is consistent with public health.” In their press release the FDA did say the public can still comment on the guidance, and it will consider all comments received and revise the guidance document as appropriate.

Hearing News will continue to report on the reactions of all key stakeholders to this regulation change.

ADA Supports OTC Hearing Aid Bill; AAA Applauds FDA Decision to Eliminate Waiver

By HHTM

In a move that perhaps caught some in the audiology community by surprise, the Academy of Doctors of Audiology (ADA) announced its support of S.9, the Over-the-Counter Hearing Aid Act of 2016. In a statement released by ADA, it said that the organization “commends Senators Warren and Grassley for their foresight in introducing and advancing this legislation, which if enacted, will remove unnecessary and burdensome barriers to hearing care for millions of Americans”.

The Over-the-Counter Hearing Aid Act of 2016 (S.9), if enacted, would allow hearing aids “intended for use by adults to compensate for mild to moderate hearing impairment” to be sold to consumers over the counter (OTC). In addition to eliminating the requirement for medical clearance to purchase a hearing aid, the legislation would also task the FDA with issuing appropriate regulations for the safety and labeling requirements for the new OTC category of hearing aids, as well as update the draft guidance on Personal Sound Amplification Products (PSAPs).
 
The ADA and its members seek to foster expanded access for consumers to audiology services. We strive to accomplish this goal through the advancement of practitioner excellence and high ethical standards in the provision of quality audiologic care. The Over-the Counter Hearing Aid Act will help to facilitate these objectives and is consistent with the ADA’s mission and philosophy. -Exerpt from ADA Statement in Support of S.9
 
While the organization supports the proposed legislation, ADA recommends that all over-the-counter (OTC) products be very specifically labeled and include a strong recommendation that a patient seek a comprehensive audiologic evaluation from an audiologist or physician prior to purchasing any device for the treatment of hearing loss, particularly if the patient exhibits any of the warning signs of ear disease (including tinnitus, dizziness, drainage from the ear, sudden hearing loss, asymmetric hearing, foreign body in the ear, cerumen impaction, pain, congenital or traumatic deformity of the ear).

ADA recommends that labeling state that the device is a “non- surgical, air conduction hearing aid intended to address mild to moderate hearing loss.” It also recommends that all amplification devices be required to adhere to defined maximum output thresholds.

ADA contends the availability of OTC hearing devices, including appropriate labeling and safeguards, will allow consumers to make better informed decisions about their treatment options, and will likely also make products more affordable and accessible to the hearing impaired.
 
“The ADA stipulates that there are risks with self-treatment, including overlooking conditions that warrant medical intervention. However, we contend that in the current regulatory environment, those risks are already being taken with either limited information–or worse yet, misinformation.”
 
According to the statement, ADA believes that the current regulatory environment has not kept pace with rapid advances in technology and by creating an OTC hearing device market, it “will foster competition, broaden consumer choice, improve affordability, and accelerate future innovation.” Furthermore, because consumers already have direct-to-consumer access to hearing aids and similar unregulated technologies via the internet, the creation of a regulated OTC class will not increase existing risks to the public.
 

AAA Offers Support of FDA Decision

With the announcement earlier this week that the FDA will no longer enforce the requirement for medical clearance to purchase a hearing aid, the American Academy of Audiology (AAA) released a statement applauding the decision of the FDA.
 
“The Academy is thrilled that the FDA has heeded the comments from stakeholders in the hearing health community and has taken immediate steps to improve hearing aid accessibility for patients and remove unnecessary barriers for those seeking hearing health-care.” –Ian Windmill, PhD, AAA President
 
Having long advocated for such a move by the FDA, the Academy says that it “applauds” the decision.

Customized Hearing Health Care

By Dr. Nancy Tye-Murray

This week at Hearing International we are pleased to have guest author, Dr. Nancy Tye-Murray of Washington University, St. Louis Missouri. Dr. Tye-Murray has been working in the area of Aural Rehabilitation for many years and now has designed a new Aural Rehabilitation Program called clEAR™ .

In today’s changing hearing healthcare environment, more and more audiologists are adopting the philosophy of “customized hearing healthcare” to distinguish themselves from the competition. Customized hearing healthcare has four key elements: understanding and treating the patient’s particular hearing-related communication challenges, including the frequent communication partner in the aural rehabilitation plan, creating a sense of belonging and a community among patients who share hearing-related communication difficulties, and last but by no means least, joining the patient on the hearing healthcare journey. This short article is about that last element, being a part of the patient journey.

But first, a little history. Before the advent of the truly wearable hearing aid, which coincided about the time soldiers began returning from World War II with noise-induced hearing loss, the only option available to patients with hearing loss was to receive speechreading and auditory training. Today, we associate speech perception training with computerized programs that are often completed by patients via a personal computer in the home environment and usually, with little contact with an audiologist (e.g., LACE; Read My Quips).
But by looking at history, it’s possible to see that by computerizing some of our aural rehabilitation interventions, a crucial element of the treatment has been eliminated. As two examples, consider first an excerpt from the speechreading training curriculum developed by Edward Nitchie (1918)  and then one from the auditory training curriculum developed by the otologist, Victor Urbantchitsch (1895) (Pictured above, ca 1920):

Nitchie: Have an “assistant read a story (e.g., Ben Franklin, Issac Newton) to you without voice…until you follow half or more…have your assistant read it again, this time with interruption….let your assistant ask you questions about the story…then endeavor to carry a short conversation with your assistant about the story...”

Urbantchitsch: “I begin by speaking aloud a sustained vowel, usually /a/ or /o/... If these attempts yield no result, I repeat them with increased intensity accomplished by shaping a funnel with the hollow of both hands through which I speak into the ear... [We might resort to] two persons shouting /a/ simultaneously into both ears...”

If you’re thinking that I’m about to suggest that you hire two people to holler into your patients’ ears, you are mistaken. But what I am suggesting, and which is often sorely missing in modern aural rehabilitation curricula and treatment plans, is that hearing healthcare professionals should give their patients more personal attention, both in terms of feedback and support throughout the aural rehabilitation plan. As illustrated beautifully in the two excerpts above, in bygone days, either the hearing healthcare professional or a hearing healthcare assistant oversaw training and provided support and feedback about progress in an ongoing fashion.

clEAR™ (customized learning: Exercises for Aural Rehabilitation) provides affordable auditory training to persons who have hearing loss and is designed to enhance people’s abilities to recognize the speech of their frequent communication partners and the speech of everyday talkers, especially in noisy environments. A unique feature of clEAR is that it includes a recording and automated editing system so that patients can receive customized training designed to help them recognize the speech of a specific frequent communication partner (FCP). Patients also have the option of training with generic voices that are stored on the clEAR website, and may choose to train with male, female, or child speech samples. A second unique feature of clEAR is that the training activities are presented in a game-like format so that training is engaging. The clEAR website also creates an easy way for audiologists to stay in contact with their patients.

We provided clEAR auditory training to about 100 patients with hearing loss and had an over 95% compliance rate (meaning that patients completed the training program) (Tye-Murray et al., 2012). At the end of their training, we asked each patient, “What did you like best about the experience?” The most popular answer was some variant of “Regular contact with an audiologist” and “Knowing that a professional cares about my progress.” It should be added that the contact patients had with the audiologist during our study was minimal. An audiologist greeted them when they arrived and led them to the computer training station for the training. After the training, an assistant thanked them for coming and reminded them of their next appointment. Total contact time was about five minutes. (Click here for a video)

There is a very powerful message in this research outcome: An effective way for an audiologist to be more competitive with the Sam’s Clubs and the Costco‘s of the world is to maintain contact with their patients after the hearing aid fitting (and even if the patient doesn’t opt for a hearing aid) and to convey the sense that they genuinely care about the patient’s predicament and about being an important component of the solution.

Contact can be accomplished as just described, with the patient coming to the clinic for a course in auditory training delivered via the Internet. It also can be accomplished by having the patient receive auditory training and the concomitant support with a personal computer at home. At clEAR, we recommend that patients be enrolled in the clEAR program with the following procedures:

1. Patients’ hearing predicament is assessed and treated (e.g., with appropriately fitted hearing aids if aids are warranted and the patient is motivated).
2. If deemed a candidate for clEAR (candidacy for auditory training in general will be the subject of a future article), the audiologist enrolls the patient and provides both an orientation to the website and provides the patient with an auditory training schedule a the practice site. An array of training schedules are available, based on the patient’s predicament (e.g., a new hearing aid user; a patient who wants to better understand females’ or children’s voices better).
3. Patients continue training at home.
4. Throughout training, the audiologist stays in contact with each patient via semi-canned emails (e.g., “Hi Ms. XXX, I see that you played the XXX game for XXX minutes today. Congratulations on you score of XXX……”, where the XXX fill in automatically by the clEAR software).
5. The audiologist also stays in contact with the clinic’s clEAR community of patients by posting regularly on a communal message board.
6. The audiologist may perform an assessment before and after and even during the training, using the assessment materials stored on the clEAR website.

Using clEAR is just one example of how an audiologist can become part of their patients’ hearing healthcare journey. Becoming part of the patient journey doesn’t have to be expensive for the audiologist, either in terms of time or effort and the payback can be enormous. Just ask your patients.
 
Nancy Tye-Murray is a Professor at Washington University in St. Louis and the author of five books, including Foundations of Aural Rehabilitation: Children, Adults, and Their Family Members (4th Edition, 2015), and over 150 peer-reviewed articles. Funded by grants from the National Institute of Health, her research focuses on audiovisual speech recognition, auditory training, and speechreading training. She is also the CEO for clEAR (customized learning: Exercises for Aural Rehabilitation).
 

References

Tye-Murray, N., Sommers, M. S., Mauzé, E., Schroy, C., Barcroft, J., & Spehar, B. (2012). Using patient perceptions of relative benefit and enjoyment to assess auditory training. Journal of the  American Academy of Audiology, 23(8), 623-634.
Urbanisch, V. (1895). Uber Horubungen bei Taubstummheit bei Ertaubung I’m spateren lebenstalter, Gyan Books, Pvt, Ltd.  Retrieved December 13, 2016.

US Hearing Device Patents for November 2016

By Holly Hosford-Dunn 

On the Demand side, marketeers talk about creating and growing markets by identifying needs (e.g., hunger) and turning them into wants by creating products that offer more and more satisfaction (e.g., hamburgers, then caviar). Economists talk about growing demand by foreseeing consumer preferences across all possible goods which deliver the greatest satisfaction within their budget constraints (the champagne taste on a beer budget problem).  Regardless of approach, it’s the collective behavior of consumers that shapes the Market, aka the Demand schedule.

On the Supply side, marketeers talk about creating buzz and excitement to sell new products, coupled with desirable pricing and branding. Economists talk about technological innovation and increased productivity to create new and better products more efficiently than competitors. Regardless of approach, it’s the competitive behavior of suppliers that shapes the Supply schedule.

Patents and patent protection of specialized “products” are key competitive behaviors of successful suppliers, especially in technologically intensive areas. They help keep price high enough to encourage continued production and development by protected suppliers; they discourage lesser competitors’ endeavors, which may slow innovation in the short run. But in the long run, they shift Demand by creating more utility for consumers.

It’s been so since the time of the ancient Greeks, when “any new refinement in luxury” was encouraged in the Greek city of Sybaris by ensuring that “the profits arising from which were secured to the inventor by patent for the space of a year.”

What kind of technologies were being developed and innovated back in 500 BCE by Sybarites, when ancient Greece had only recently emerged from its own Dark Ages and entered the Iron Age in metallurgy? True to their name, and setting the stage for consumers and suppliers throughout the ages, Sybarites were interested in developing and protecting  ever more sybaritic tastes, starting with the culinary. According to Phylarchus, “exclusive rights were granted for one year to creators of unique culinary dishes.”

So much for hamburger and refining the sense of taste by patenting culinary arts. Later cultures expanded into the other four senses, inventing to influence consumer preferences and grow demand by improving consumers’ ability to see, feel, smell and hear.

We’ve Come A Long Way, Baby

The years of  plain vanilla amplifiers squealing in the ears and worn only by those with hearing loss are past us. Now, suppliers of Hearables by any name are aiming for the best sound, least noise, most content, longest battery life, fastest processing, widest connectivity, smallest size, greatest multi-functionality, most comfort, most attractive, and, of course, broadest market. And, of course, we sybaritic consumers want it all now, at the lowest price we can get, and preferably over the counter so we can pick it up at takeout, just like our food choices.

Inventors and suppliers are undaunted by this demanding set of demands from the Demand function. On the contrary, they’re spurred on to more and better ear device creations, as we’ve been seeing in the traditional hearing aid manufacturers’ products as well as from consumer electronics firms and start ups. The patent applications and awards are proof of progress, as well as protection and pricing.  Reading what’s envisioned is a bit mind boggling, even if we limit functionality to “only” audio. Consider this dense description in a patent application by Mass Moment LLC:
A multifunctional wearable audio-sensing electronic device is disclosed in which audio is detected, detected audio is analyzed to determine characteristics of the audio, a warning is generated in response to determining that a decibel level of the detected audio is physically harmful, when the wearable audio-sensing electronic device is in a musical tuner mode, a deviation of the audio from a pre-determined audio characteristics of a musical instrument is displayed, when the wearable audio-sensing electronic device is in a hearing aid mode, an identification of the audio and a direction from which the audio originates is displayed, when the wearable audio-sensing electronic device is in an ambiance indicator mode, a visual representation of an audio ambience is displayed, and when the wearable audio-sensing electronic device is in an audio recorder mode, the audio is recorded to the memory and played back. (USPTO #9500515)

Sybarites rejoice. The luxury of exclusive and highly personal audio is available and preferred.

The November List

Editor’s note:  The Patent Series is updated monthly now, and every two months in the past. Click links for patents approved in October 2016, Sept 2016,  Jul/Aug 2016,  May/Jun 2016, Mar/Apr 2016, Jan/Feb 2016, Nov/Dec 2015,  Sept/Oct 2015,  Jul/Aug 2015,  May/Jun 2015,  Mar/Apr 2015,  Jan/Feb 2015,  Nov/Dec 2014,  Sep/Oct 2014,  July/Aug 2014,  May/Jun 2014,  Mar/Apr 2014,  Jan/Feb 2014,  Nov/Dec 2013,  September/October 2013,  Jul/Aug 2013,  May/Jun 2013,  Mar/Apr 2013,  Jan/Feb 2013,  Nov/Dec 2012

Reproduced with kind permission from hearinghealthmatters.org.