Sana AudioPulse Massachusetts Institute of Technology (MIT) Students: Advisors: Federal University of Rio Grande do Norte (UFRN) Marzyeh Ghassemi Kenneth Paik Talis Lincoln Barbalho Ana Gizelle (Harvard) Lauren Scanlon Ribeiro (NorthEastern) Andrew Schwartz Dr. Leo Anthony Celi Dr. Ikaro Silva Dr. Peter Szolovits Dr. Ana Guerreiro Abstract Detecting hearing loss in the first 6 months of life is essential to prevent permanent communication deficits. An estimated 588 million people had mild or severe hearing loss globally in 2000. In Brazil, an estimated 26.1% of the population had some level of hearing impairment in 2003. For rural and/or poor populations, access to an audiology clinic is costly and difficult. Sana AudioPulse presents a low-cost, portable method for ubiquitous national detection of hearing loss. Our application uses cellphones interfacing with specialized hardware to objectively screen newborns for hearing impairment with a suite of hearing standard pediatric screening tests. The audiological data is securely transmitted wirelessly to a remote centralized medical database for certification and validation by professional audiologists. Our one and three-year projections estimate a net income of $39,000 and $575,000 USD during the first and third year (10 then 50 healthcare facilities). 1. Background Global Issue In 2000, the WHO estimated 588 million people had mild or moderate-toseverehearing loss. (Mathers 2000) In 2003, an estimated 26.1% of the Brazilian population showed some level of hearing impairment, and 6.8% were classified in the disabling hearing impairment group. (Beria, 2003) The consequences of untreated hearing loss are high. After 6 months, the cognitive ability to process sounds significantly degrades in an irreversible manner. (Harney 2000) Even minimal degrees of hearing loss result in significant permanent degradation of speech and linguistic abilities. (Olusanya, 2011) Delayed and insufficient language development can negatively affect academic achievement, social skills and future employment. The estimated lifetime cost of hearing loss for a child with prelingual onset exceeds $1 million USD, and many people who are deaf have difficulty gaining employment. (Mohr, 2000) Focus on Brazil Brazil has an estimated 5.7 million people with some degree of hearing loss. The situation for children is worse: 6% have hearing loss by age 4, and 6 in 1000 have hearing loss from birth. (Botelho, 2010) Given an estimated 3,023,000 births in Brazil, more than 22,000 infants and 222,000 children are impacted each year. (UNICEF 2010) The Brazilian government recognized the severity of this problem, and instituted a federal law (2794/01) obligating a hearing test for every newborn within the first week of birth. 2. Problem Many infants go untested, despite Brazil’s government mandate, at great cost to the family and society. (Ashoka Foundation) The Brazilian health care system has only 87 audiology equipped centers that are located only in major cities. These centers distribute around 150,000 hearing aids per year at an average cost of $300 each. These are primarily in the south and southeast regions of the country, as the cost of the hearing-test equipment alone is over $18,000 USD in Brazil (usually imported from U.S.). For rural and/or poor populations, access to an audiology clinic is costly and difficult. Patients are referred to private hospitals, where the test is $60 USD per patient and possibly in another city. The $60 USD price represents almost 3 days of income for an average Brazilian making only $9,000 USD per year. The few public hospitals with the necessary equipment tend to have long wait-times that can last for hours or days; even with this wait, the test is still $15 USD per patient. Thus it is not uncommon for hearing problems to go undetected and untreated, resulting in academic deficits, safety risks, difficulties maintaining employment, and interpersonal challenges. 3. Solution Brazil needs a low-cost, portable method for ubiquitous detection of hearing loss. Reducing cost and increasing portability is similarly crucial to any hearing loss solution in the developing world. Brazil’s high penetration of the cell phone market makes a mobile solution ideal. With over 90% coverage, 4 major competing companies, and 132 cellphones per 100 inhabitants, mobile phones could provide inexpensive and ubiquitous auditory screening. The Sana AudioPulse team has developed an application, using cellphones interfacing with specialized hardware, to screen for hearing impairment in newborns with a suite of hearing screening tests. A detailed walkthrough of the Sana AudioPulse application can be seen in the Application Screenshots section. Data is securely transmitted wirelessly to a centralized medical database for validation by a trained audiologist and storage in a medical record database. Our application is developed for the Android mobile operating system, and specifically for Android 2.1 or later. Using mobile technology allows for wide-spread deployment of hearing screenings across a broad span of Brazilian communities. Sana AudioPulse also captures GPS information from cellphones. This data will be used to determine several broad public health questions regarding the future allocation of screening, detection and treatment services. These data will also be helpful to visualize geographical areas which are being covered by the program versus those which we have potential for a new market. Sana AudioPulse will be used by non-audiologist medical staff at the field hospitals to administer a hearing test using the a portable hardware capable of performing Distortion Product Otoacoustic Emissions (DPOAE) and Tone Burst Otoacoustic Emissions recordings(Etymotic ER-10C). The ER-10C (Figure 8) is a well-known specialized piece of hardware designed for psychoacoustical measurements; using ear probes, the evoked response to two test frequencies is used to generate assess information about the auditory system. This auditory data is transmitted the ER-10C via a cable (or Bluetooth) to a cell phone running our customized AudioPulse software. Furthermore, the cell phones equipped with Sana AudioPulse, additionally guide the medical staff members through standard clinical questionary to assess the infant’s risk factors (such as family history, infections during pregnancy, or otoacoustic drugs delivered). Sana AudioPulse uploads the risk-factor information along with the ER-10C evoked recordings to a remote hospital electronic medical record system, where authorized audiologists certify and authenticate the results. Once results are interpreted, audiologist can send requests for further on-site information (pictures, patient history, etc.), or prescribe a visit to a follow-up audiology center via the phone’s SMS (text messaging) service. 4. Business Model The Sana AudioPulse platform benefits from significant commercial advantages in cost and portability, while facilitating access to highly trained medical professionals. Our business model is to roll out the system to public and private hospitals and clinics that lack existing audiology equipment. The Sana AudioPulse hardware will be made available at low or no cost, with revenue generated via a transaction fee per test and reading. Consumer Benefit Hospitals with already overburdened resources have a difficult time justifying the capital costs of purchasing the old audiology equipment and hiring the required on staff audiologist. These hospitals are unable to cover these capital costs because they can’t adequately directly bill their patients as many of these include the rural poor, while the government reimburses at an inadequate $3 USD per test. The Sana AudioPulse platform will be offered to hospitals for a low startup cost, well below the $18,000 USD for existing hardware. Furthermore, hospitals will not need to retain an audiologist on staff, as the Sana AudioPulse will upload the hearing test data to be interpreted by a remote on audiologist. The hospital will be charged a transaction fee of $3 per upload, which is completely offset by the government reimbursement rate, resulting in a net zero additional cost. Financial Analysis Our first-year projections are based on an average 20 births per day in 10 community hospitals. Significant costs include server hardware and maintenance, device hardware, and staff audiologists. By retaining trained audiologists to only interpret the test results, we are able to use their time more efficiently, allowing a single audiologist to cover the output of up to five or more hospitals. The three-year projections estimate scaling the platform to 50 total clinics in Brazil, resulting in a net income of $575,000 USD. See the financial projection in Section 8. Initial Setup The Sana AudioPulse pilot will be implemented over the course of 6 months in Natal, Brazil. A detailed timeline is shown in the section 5 timeline table. As students at MIT develop the mobile application, UFRN students will begin server and cellular network setup in Brazil. Before deploying the application in Brazil, there will be a local pilot at Children's Waltham Hospital to compare with state of the art hearing screening methods and the remote analysis of the system. Once the systems have been validated, Sana AudioPulse will be integrated with the Audiology Clinic of the UFRN University Hospital as a system field test. This will then lead to data collection from maternity university hospital in Natal for approximately a month, where our system will be compared with standards and commercial methods. Future Directions In addition to community hospitals, the platform could be offered to alternative community access points to healthcare, particularly the widespread vaccination clinics. These generally publicly supported clinics interact with newborns and children to administer vaccines throughout Brazil according to the schedule established by the National Immunizations Program (PNI). As the Sana AudioPulse platform does not require highly skilled labor, the nurses or healthcare workers could additionally administer the hearing test to newborn, rather than requiring them to travel to a community hospital. 5. Timeline April May June July August Sept Application Development Server/Cellular Network Setup in Brazil Pilot Testing At Children's Waltham Hospital Sana AudioPulse Integration with Brazilian System Field Test of Entire System with Initial Hospital (Maternity of UFRN) In-field Data Collection With 4 Hospitals (> 100 Patients) 6. Conclusion Sana AudioPulse integrates an innovative medical device with ubiquitous smartphone enabled cellphones for ubiquitous national detection of hearing loss. We require no new medical staff to be hired on by healthcare facilities, instead using mobile technology to extend the reach of current medical professionals. Our business model targets a vital area of interest to the Brazilian government and care providers. Our application and overall platform have significant commercial advantages in cost and portability. Revenue is generated via a $3 transaction fee per test, matching the current government reimbursement rate. Our strategy is therefore a net zero additional cost to healthcare providers. Our system overcomes resource and infrastructure limitations, bringing medical expertise and important childhood screening tests to the rural and poor. After our initial pilot of maternity hospitals this September, we plan to expand to 10 and then 50 healthcare facilities in the first and third year of the project. Our mobile platform is focused on improving quality of life, educational development, and societal productivity. Sana AudioPulse is a revolution in childhood screening: an economically sustainability solution democratizing quality care. 7. References Botelho, F. A., Bouzada, M. C. F., Resende, L. M. D., Silva, C. F. X., & Oliveira, E. A. (2010). Prevalence of hearing impairment in children at risk. Brazilian journal of otorhinolaryngology, 76(6), 739-744. Mathers C, Smith A, & Concha M. Global burden of hearing loss in the year 2000 [Internet site]. Available from: http://www.who.int/healthinfo/statistics/bod_hearingloss.pdf. Accessed March 30, 2012. Beria J. Prevalence of deafness and hearing impairment: Preliminary results of a population -based study in southern Brazil. Informal Consultation on Epidemiology of Deafness and Hearing Impairment in Developing Countries and Update of the Who Protocol. WHO, Geneva, March 2003. Harney CL. Infant hearing loss: the necessity for early identification. Bol Assoc Med PR. 2000;92(9-12):130-2. Olusanya BO, Bamigboye BA, & Somefun AO. The burden and management of infants with life-long and irreversible hearing impairment in Nigeria. Niger J Med. 2011 JulSep;20(3):310-21. Review. Mohr PE, Feldman JJ, Dunbar JL, McConkey-Robbins A, Niparko JK, Rittenhouse RK, & Skinner. The societal costs of severe to profound hearing loss in the United States. MW. Int J Technol Assess Health Care. 2000 Autumn;16(4):1120-35. Weinstein H. 2008 Ashoka Fellowship, Ashoka Foundation [Internet site]. Available from: http://www.ashoka.org/fellow/howard-weinstein. Accessed March 30, 2012. 8. Financial Projections Year 1 Hospitals Births per day per hospital Transaction Fee Year 2 Year 3 10 20 3 20 20 3 50 20 3 $219,000 $438,000 $1,095,000 Server Cost/Maintenance Software Development Hardware Cost/Loss Audiologist SG&A $30,000 $80,000 $10,000 $40,000 $20,000 $30,000 $160,000 $20,000 $80,000 $40,000 $30,000 $160,000 $50,000 $180,000 $100,000 Net $39,000 $108,000 $575,000 Revenue In US Dollars 9. Application Screenshots Figure 1- Main Menu Figure 2-The App will allow for series of objective hearing tests that do not require response from the patient (ideal for infant testing). Two of these are DPOAEs and TBOAes (see text for detail). Figure 3- Risk factors for the infant are collected in order for the audiologist to them into account when assessing the final diagnosis. This list is highly customizable and easily scalable. Figure 4- Results of the ER-10C hearing test is automatically displayed on the cell phone App for real time assessment of the infant’s hearing for preliminary notification (until final confirmation by an audiologist). The pink region represents a border-line loss, and a response *below* the pink region represent moderate-tosevere loss. Figure 5- The data is transmitted to a remote electronic medical record system for professional validation. This figure shows the queue for patients waiting for an audiologist’s confirmation of the test results. Figure 6- The audiologist has access to more sophisticated and professional analysis at the back-end of our applications. This graph the frequency of both stimuli and the patient’s physiological response. Figure 7- Other detailed data of the auditory test accessible to the physician include the risk factors (left column) and the detailed audiogram including stimulus level, physiological response, and noise floor levels. Figure 8- The ER-10C is a $3,000 portable, specialized hardware capable of recording otoacoustic emissions.