Guest article: Will the Mobile Medical Apps transform hearing healthcare?
By Tarik Zukic
Editor’s Note: From time to time The Hearing Blog presents guest articles for our Readers to consider. Today’s article by Tarik Zukic, who is the Managing Director of 2Pi GmbH in Vienna, will bring a fresh perspective on mobile medical apps as applied to the hearing healthcare industry worldwide.
The convergence of hearing aids and personal mobile platforms like smartphones is opening a way for new and innovative applications. The first product offerings from the hearing aid industry are promising: GN ReSound has generated a healthy dose of excitement with its foray into the Bluetooth 4.0 Low Energy (“BLE”) territory and the anticipated SoundPoint-styled app from Starkey is promising a real innovation by allowing the user to substantially adjust his/her hearing aids. But will the new technology transform hearing healthcare and reach new customers?
Despite of technological possibilities the effectiveness of providing hearing prosthesis has not changed since decades. And while the industry relies on demographic and geographic developments to guarantee the future growth, the conventional hearing aid concept has failed to attract customers outside the traditional set. We can even speculate that if the growth figures are adjusted for demographic and geographic developments (including purchasing power) the penetration of the hearing aid market is actually shrinking.
The hearing aid industry of today is an interdependent ecosystem. Manufacturers and conventional hearing aid retailers are united in understanding that the equilibrium of the ecosystem serves best the interests of all relevant actors. New products are conceptualized and engineered according to the slowly changing demand of traditional purchasers. A substantial innovation, aiming at creation of totally new product class, seems to be inhibited by the risk of co-adoption in the ecosystem of hearing aid. [An enlightening discussion of co-adoption risks is described in the book The Wide Lensby Ron Adner1]. Evidently, the future of innovation in the hearing healthcare industry will depend not only on the technology, but on other factors as well, which we will discuss in this article.
The introduction of smartphone-based solutions has the potential to be a game changer: Unlike the internet boom that failed to significantly affect hearing healthcare, smartphone technology is much more suitable. Being an isolated and relatively standardized device, a smartphone can better comply with safety requirements. The touch-screen and the available computing power can provide a seamless audio-visual interface between the user and his/her hearing aid.
Direction of Innovation in the Hearing Aid Industry
The existence of innovation pessimism in any high-tech industry of today may seem unlikely at first, especially that the signs of technological excellence are everywhere. But as soon as distinction is made between the fundamental innovation, the one that provides a basis for a substantial growth wave, and the incremental innovation that maintains profitability but has no purpose of creating new market opportunities, one can confirm a modest innovation pace in many technology driven industries.
Two types of Innovation
In his seminal book The Innovator’s Dilemma1 Harvard professor Clayton Christensen introduces the concept of disruptive innovation in technology driven products. His model makes a distinction between the incremental and disruptive innovation and is valid for the hearing aid industry of today. Two aspects are particularly interesting:
- The successful industry players are focused on covering demands of their biggest purchasers. The manufacturers concentrate on incremental innovation in order to satisfy the demands of those customers and they are efficient at it. But this optimization puts the internal innovation under pressure. The very strength of supplying the existing customer creates a disability to spot a new market opportunity and innovate in a disruptive way.
- The market demands on performance are continuously growing, but the technological advance is often happening at higher rate. As a result one technology solution can surpass the market demands. To innovate only technologically is therefore not enough; the innovation must reference the product concept and value proposition.
In the terms of the hearing aid industry that means the following:
- Following the digital revolution of the 1990’s, incremental innovation was pursued together with strengthening operations-based part of the value chain. A conventional hearing aid product has been since equipped by an impressive variety of new features: Inspired algorithms, waterproofing, colorful styles and rechargeable batteries. By optimizing the performance in serving their traditional customers (individual practitioners in the US, dispensing chains, and European & UK government health services) the leading hearing aid manufacturers essentially overlook large groups of potential customers and markets: Traditional non-adopters, emerging economies, and so forth;
- The ever increasing technological performance of a state-of-the-art hearing aid and the complexity of related services are outpacing the demands of the mainstream market and might not be necessary for the majority of the users.
The question is: will Made for iPhone hearing aid be utilized as just another incremental innovation or will it be employed for accelerating market growth in line with promises of demographic and geographic developments?
iPhone as a medical device – market demand, technology potential and regulations
Increased availability of smartphones will inevitably lead to a revolution in the app-based diagnostic devices. The computational power as well as the quality of built-in sensors and user interface rapidly surpassed the technology used in many professional diagnostic devices. While the technological advantages of the smartphones are obvious, the regulatory issues related to the technology are catching up slowly.
Despite of a complex procedure for approval of medical products by FDA, TÜV, and similar bodies, there has been an increased introduction of medical apps for mobile phones, and especially iPhone. Examples of such devices are iPhone ECG from AliveCor, iBGStar’s glucose monitor and Scanadu’s Scout. [Editor’s Note: The Remotoscope iPhone-based otoscope and companion app developed at Georgia Tech was previously covered by The Hearing Blog.] All of those devices require additional sensor hardware that has been cleared by the FDA. In terms of regulations, the main dilemma is the fact that the diagnostic device is meant for use by the patient himself – in absence of a supervising professional. The main concern of the FDA is that the supervision of a doctor or nurse has to be fully replaced by the functionality of the app (software)3. In the case of hearing healthcare, the FDA is especially concerned about internet-based sales of hearing aids.
FDA and mobile medical apps
In 2011, the FDA drafted a guidance protocol for the regulation of Mobile Medical Applications as means of ensuring safety in medical products. Once the regulations are defined they will encourage further development of such products. New entrants will be attracted by an emerging market opportunity. It can indeed happen that the clear FDA regulation of Mobile Medical Applications will eventually lead to deregulation of common practices in the hearing aid market.
Made for iPhone” hype and invasion of PSAP’s – in search of the Killer App
The recent hype about “made for iPhone” hearing aids and the market-invasion of PSAP’s are not isolated events. They are both an expression of the confidence that the technology can challenge the prevailing market conditions and boost the growth. What can be changed?
Mobile Medical App for increasing hearing aid acceptance
Acceptance of hearing aids is an important issue. According to MarkeTrak, in the US, as many as 13% of fitted devices are not actively used – expensive high-tech products are ending up in a drawer.4
Main reason for the low hearing aid acceptance is the dissatisfaction with the nature and quality of the sound provided by the hearing aid. This again depends on the adjustment of signal processing parameters of the device. For the first-time-users the sudden change in the sensory experience of the environment is a stressful event that sometimes leads to the user abandoning the hearing aid device.
Smartphone connected hearing aids can provide valuable support during the acclimatization phase, where the user can re-adjust the hearing aid frequently and optimize speech intelligibility and listening comfort in real-time. By providing an appropriate human interface to the hearing aid device on a smartphone, the hearing aid device will automatically feel to the user to be more controllable and this will lower the likelihood of rejection.
Mobile Medical App enables Telehealth
Telehealth solutions have a great potential at both outermost ends of the hearing aid market: they can provide unique features for maximizing the benefits of the premium devices but also extend the offering on the lower end of the market by replacing expensive visits to a medical professional.
Mobile Medical App for fitting accuracy and alternative distribution channels
The majority of conventional hearing aids is being sold in bundle with audiology services. This model has been successful in serving traditional customers, but seems to raise an impenetrable barrier for the non-adopters. As a reaction to these market conditions a variety of PSAPs and internet-sold hearing aids have recently been introduced to the market.
The majority of PSAP’s and internet-sold hearing aids that target the customers behind the adoption barrier lack appropriate adjustment and none of them provide diagnostic capabilities. This significantly reduces the user benefit that those products can provide.
Integration of hearing aid with smartphone can provide major advances in hearing loss diagnostics and patient-driven fitting. Interactive procedures that involve audio streaming of test sounds from smartphone to the hearing aid can offer high accuracy of hearing loss estimation and provide a satisfactory prescription. Especially for mild to moderate sensorineaural hearing loss this solution has a potential to be equivalent to the conventional fitting procedure.
Substituting professional guidance during the fitting procedure must of course be taken seriously. By implementing sophisticated precautions, an interactive fitting app can support a high level of protection from incorrect diagnosis. Furthermore, interactive procedures that increase the level of involvement by the patient in the process of hearing aid adjustment (such as the SoundPoint feature in Starkey Inspire programming software) have a positive effect on the fitting outcome.
The prospects of user-driven fitting raise concerns about the quality of patient care and about the future of the audiologist profession. However, if the novel solutions are carefully designed for best possible performance and in turn significantly increase the market size, both concerns are unjustified. It is likely that a large portion of the traditional customers would still prefer professional and personal service.
Mobile Medical App for hearing aid availability in emerging markets
Relatively high prices and the low availability of hearing aids are the main reason for low market penetration in emerging economies. For example, there are only 1500 registered audiologists serving India’s population of 1240 million.5
The often tedious approach of building upon the conventional audiological infrastructure doesn’t need to be the only recipe for growth. Examples from other industries can serve the hearing aid industry well. In India the landline telephone network was never developed to satisfy the needs of the population. Instead, the use of mobile telephones made the need for a better landline network obsolete – a technological leap forward was far easier and significantly more efficient than the slow evolving process of expanding the established technology. Smartphone banking in India and Africa swiftly improved availability of bank accounts among those in the population, who have never had bank accounts and have been excluded from the money transactions. Their first experience with a banking institution was internet banking.
As a result, instead of providing audiology services via an extensive network of brick-and-mortar shops and specially trained audiologists, this service can be replaced by sophisticated smartphone-based fitting solutions. This will increase the availability of hearing aids far beyond the potential of traditional distribution channels. — This can also be an interesting business idea for global hearing aid retailers as well.
Mobile Medical App integrates hearing aid in the network of digital body extensions
Human interaction with technology is increasingly ubiquitous and uninterrupted. Social-networking features and use of technology as human sensory extensions are demands applied to an increasing number of products. The in-the-ear or ear-worn form factor of a hearing aid is perfectly aligned with the trend of technology portability (compare it with Google Glass).
The changes in the society and the workplace with increasingly overlapping natural and virtual living environments will also influence the very definition of human sensory capabilities and therefore also the concept (probably multiple concepts) of hearing impairment.
Providing an interface between the hearing aid, the user and the other personal communication devices, Mobile Medical App app can play a central part. Even if this discussion might resemble a science fiction enthusiasm of the 1960’s, the first indication is evident: the border between a hearing aid and a Bluetooth headset is just about to disappear.
Some products with potential
The following list of commercially available products and announced features exemplify the trends that outline future use of smartphone technology in the hearing healthcare.
Resound Unite Phone Clip+ (including companion Control iOS and Android app)
The remote control features are very conventional and have no disruptive potential. The technology, however, is capable of quickly providing novel disruptive features such as remote device fitting or fine tuning. Stay tuned![Editor’s note: The USB AirLink programmer is used for this function: Please see Telehealth for Programming Hearing Aids and MAPping CI’s] [Editor’s note: The Beltone Direct Phone Link 2 and ReSound Phone Clip+ are identical, as are the Beltone Smart Remote and ReSound Control apps.]
SoundPoint feature for fine tuning of devices is the avant-garde interactive feature of conventional fitting software where the control of the signal processing in the hearing aid is in the hands of patient. Unlike in the case of audiologist-conducted paired comparison method, the patient doesn’t communicate with the professional but only interacts with the iPad-based app.6[Editor’s Note: Starkey has just extended this concept with a companion iPad app for fine-tuning tinnitus suppression therapy]
Sound ID/Ear Print
This App works in conjunction with a Bluetooth headset, but with a potential for use in connection with hearing aids as a flexible sound quality remote control, or as an intuitive but unguided tool for fine tuning of amplification parameters.
EAR Machine/EARS app
EARs uses similar approach as Sound ID/Ear Print. It is based on patented method of mapping the perceived sound quality to semantic clues. It is available as an App to control the audio output of an iPhone or iPad but with a potential for use in connection with hearing aids as a sophisticated sound quality remote control, or as an intuitive tool for fine tuning.
Selffit App implements a procedure for user-driven adjustment of hearing devices that combines screening of hearing loss, first-fit, and interactive fine-tuning. It is based on a patented interactive audiovisual method for presentation of test sounds that are streamed to the hearing aid. Selffit is currently undergoing clinical trials at AMC in Amsterdam.7
- The Wide Lens – A New Strategy For Innovation: Ron Adner, Portfolio/Penguin, 2012 http://thewidelensbook.com/book.html
- The innovators dilemma: Clayton M. Christensen, Collins, 1997 [ISBN 1578518520]
- The dream of the medical tricorder – technology quarterly: The Economist, Dec. 1st, 2012
- MarkeTrakVIII: Sergei Kochkin, late of Better Hearing Institute: http://www.betterhearing.org/pdfs/M8_Hearing_aid_user_success_audiologists.pdf
- Article in Times of India: http://articles.timesofindia.indiatimes.com/2013-01-31/chennai/36657715_1_audiologists-impairment-shortage
- A patient assisted fitting: Introducing SoundPoint. Valentine, S. & Dundas, J.A. (2011); Audiology Online. Retrieved from AudiologyOnline.com http://www.audiologyonline.com/articles/patient-assisted-fitting-introducing-soundpoint-822
- Two Pi GmbH Begins Clinical Trials of Mobile Phone Hearing Aid Fitting App June 19, 2013 http://www.hearingreview.com/all-news/21778-two-pi-gmbh-begins-clinical-trials-of-mobile-phone-hearing-aid-fitting-app,
Tarik Zukic is managing director of Two Pi GmbH.
Two-Pi is an innovative technology company developing advanced intellectual property for the hearing healthcare, personal communications and professional communications markets. Two-Pi’s algorithm catalog results from a streamlined scientific program carried out with university partners.
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