Solar Ear holistic hearing health solutions

There are 650 million people (180 million children) trapped in a poverty cycle due to hearing issues that affect communication development and have important implications for brain development, learning, behavior development, personal and social relationships, and well-being [Bagatto 2016; Russ 2018]. Hearing loss in the early years of life is a “primary health condition that if not acted upon, can have a wide range of potentially adverse effects on the affected child, family and even society at large” [Hyde 2017, p. 316]. Current infant hearing care in developing countries as well as in disadvantaged and aboriginal communities within developed countries is abysmal: 140 million babies are born every year, yet only 17% have their hearing tested [Neumann 2020] while, in children, nearly 60% of hearing loss is due to avoidable causes that can be prevented through implementation of public health measures.

Within this scenario, the ubiquitous availability and adoption of smartphones offers an excellent opportunity to develop proof of concept low-cost solutions that promise to fill the gap via affordable hearing testing and thus a growing number of studies are addressing their applicability and efficacy [Swanepoel 2019].

However, to our knowledge, no research has yet proposed and validated a sustainable hearing testing model tailored for LMIC countries and disadvantaged communities together with an affordable, language-independent screening toolbox for newborns and infants that can be used on the field by trained health workers in urban centers as well as in rural or remote areas by secondary healthcare workers.

With this in mind, in collaboration with our network of partners, we propose to validate Solar Ear holistic method for hearing screening of newborns and infants in approximately fifty sites distributed within LMIC countries (Tanzania, Kenya, DR Congo, Nigeria, Brazil, Peru, India, Guatemala, Cambodia), and high-income, or developed countries (aboriginal and communities in Canada and Australia; disadvantaged areas in and US). In fact, while most research studies focus on select case studies in a specific LMIC country, we want to stress that early detection and intervention on hearing loss is needed in most countries across the world independent from the country’s income level. For example, Otitis media is endemic among Inuit, First Nations, and Métis children in northern Canada, with prevalence rates in some communities as high as 40 times that found in the urban south prevalence [Bowd 2005; Sheppard 2012; Feder 2017]. A similar situation is observed in Australian Aboriginal and Torres Strait Islander (ATSI) children [Aithal 2012].

More specifically, we propose to determine the prevalence of hearing loss in children from newborn to 11 years in the target communities. We will use our affordable otoacoustic emission (OAE) screening technology with newborns and children up to age 3 with a referral for a conductive hearing loss if needed. For pre-school and children up to 11 years old we propose a gamified, language-independent pure tone testing app (with thresholds at 500, 1000, 2000, and 4000 Hz) with data collection for children with hearing loss 30 dB or greater in either ear. We plan to have tests conducted in at least 5 different locations per country and not necessarily only in the main hospital in the capital city. We will not rely on trained audiologists, which are scarce, if available at all, in our target countries and areas. To reach the testing locations, we will use an innovative yet existing distribution network such as micro-entrepreneurs, and telehealth networks that reach the last mile-consumers, especially those that live far from urban centers and are the most vulnerable. In urban centers, we will use hospitals, schools, mid-wives, pharmacies, nursing homes, veteran centers, optical stores, and community health workers. 

We will collect feedback from end users (e.g., older children could rate their experience with a smiley, neutral, or sad face, as well as health workers could comment on their user experience). Where possible, we will add otoscopy testing to gather data about how many children have ear discharge, infection, or medical conditions affecting their hearing. Additionally, we will record information about the digital environment (access and familiarity with a smartphone or computer), medical history, and family history of hearing loss (following WHO protocol for patient info). Ultimately, it will be important to take notes about the social context to understand the local needs of the people and what they would do with the results. The data collected from the field tests will result in the largest hearing aid study on infants and newborns across different countries; it will have value for National Health Institutions to inform research and policymaking programs as well as for pharma organizations who need real-world data to develop new drugs to lower hearing loss.

Solar Ear (www.solarear.org), a sustainable social enterprise, is pioneering an affordable, holistic method to reduce hearing loss based on the first-ever suite of smart-phone hearing care Apps and affordable devices[FTD1]  (e.g., OAE, smartphone-based smart hearing aid) meet WHO medical protocols and cover solutions across the life course: when a baby is born, when a child joins a school for the first time and when people turn 55+ and hearing problems might start.Our research partners are institutions such as Cambridge University Digital Health (UK), Olin College of Engineering (US), Utah State University (US), and McGill University (CA). The WHO is committed to partnering with us to make newborn screening part of public policy.

Given we will be using different types of testing centers we will have a better idea as to the best , most affordable and accessible type of center which can bring better hearing health and other heath apps to the end -user

There are 650 million people (180 million children) who have a hearing loss, two-thirds of them are living in developing countries, yet only 12% of hearing aids are sold in these countries. There are 140 million babies born every year and over 100 million children who attend school for the first time, and less than 17% of them have had their hearing tested.  In Africa, there are 32 million infants and  children with hearing loss. Currently, it is very difficult to reverse this situation, since hearing aids are too expensive, and in addition, there is as a dearth of trained professionals to detect the problem. Consequences are especially severe for children, which are trapped in a poverty cycle. With an untreated hearing loss, a child will not learn to speak, therefore their cognitive, social, and emotional development is affected. Without the ability to communicate they are excluded from school, which continues the cycle of poverty.

Permanent hearing loss in a child should be considered a neurological emergency, not a catch-as-catch-can condition. Because auditory deprivation can have an impact on brain development and learning, the cost of inaction is being paid by thousands of children every year. “Hearing loss affects a child’s understanding and use of language,” says Dr. Baali, an audiologist and board member of Speech-Language and Audiology Canada (SAC). “It can also affect their cognitive, social, emotional, academic and communication development. The sooner we can detect a hearing problem, the better the chances for improvement and future success. “

The cost of universal screening and timely follow-up is marginal; in fact, it costs less to do early prevention and treatment than to do nothing and wait for serious hearing problems to manifest themselves. With the landmark passing of the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD), ratifying countries pledged to promote the full inclusion of people with disabilities in all areas of society. However, many nations have struggled to make significant progress in implementing the commitments set forth by the Convention. Consequently, people with disabilities are still experiencing persistent inequalities on almost all indicators of social, political, cultural, and economic participation compared to the rest of the population.

The extensive exclusion of people with disabilities from society is indefensible from a human rights and social justice perspective. However, while this may be widely acknowledged, there is a common perception that inclusive interventions are not financially feasible, particularly in the resource-constrained settings of many low and middle-income countries (LMICs). 

Although the human rights case alone is sufficient to necessitate action, there is also evidence that promoting the inclusion of people with disabilities is beneficial from an economic standpoint. The first known study to use this approach to produce global, cross-disability estimates was undertaken by Metts in a report for the World Bank. Using data from 1996-1997, Metts calculated that GDP losses in LMICs amounted to between US$473.9-672.2 billion a year. At the state level, losses in GDP reached as high as 45% for some countries. These figures were derived by multiplying each individual country’s general unemployment rate by its GDP and then applying minimum and maximum “disability impact factors” to obtain a range of annual GDP losses. In the capital cities of developing countries, hospitals tend to only test babies considered at high risk for hearing loss, such as preemies and those who have had serious infections such as meningitis. But a lot of children fall between the cracks. When hearing loss is not detected at birth, it is often not discovered until around age two, when children start speaking. Sometimes parents notice problems and manage to get help, but it’s no easy. Universal screening can make a real difference by preventing disability and helping children reach their full potential for learning and social interaction.

Health care, support services, educational opportunities, and productive employment are in critically short supply in African communities. The African Association of the Deaf strongly supports their fight for recognition, acceptance, services, and opportunities, not only within their own communities but within the larger African society as well. 

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By extension, where large clusters of communities with high incidences of hearing loss and no adequate educational and occupational opportunities exist, economic growth in the larger society is negatively affected. Research also indicates that, in general, people with disabilities account for a higher percentage of the unemployed than the national average, have less access to education and training, and have a higher rate of HIV-AIDS.

Solar Ear's mission is to scale its sustainable business which was started in 2002,by10 women who are deaf in rural Botswana. We have then replicated our model of making solar-powered hearing aids made by people who are deaf for people with a hearing loss to  Brazil, China and shortly scaling to India and Ghana. We will continue to, hire and empower people who are deaf, and with our products help children with hearing loss in LMIC's.  All our products are designed to work in remote, low-resource regions and were invented by and are manufactured by people who are deaf. Our solutions are specifically built to overcome developing countries’ biggest challenges: affordability, accessibility and using appropriate technologies which are congruent with the needs and demands of those living in LMIC's.  In countries with substantial development challenges, coordinated action needs to be taken not only by the government but by civil society to ensure that this significant portion of the population affected by hearing impairments can be guaranteed their rights of access to social services, health care services, education, employment, and full and equitable participation in society. Providing a child with a hearing aid at an early age will enable the child to be mainstreamed into local schools, and develop speech, thereby affording this child an education and a chance to break the cycle of poverty, which without a hearing aid would be virtually impossible.

We realized that hearing aids alone were not the solution to lowering hearing loss nor the burden of hearing loss. One of the other problems is the dearth of audiologists in LMIC's.In developed countries, there is 1 audiologist for every 20,000 people, and in LMIC 1 for every 2 to 6 million people. Therefore if one cannot test the child's hearing the process stops. Therefore new technology and new distribution channels has to be developed.

Solar Ear is pioneering an affordable, holistic method to reduce hearing loss based on the first-ever suite of smartphone hearing care Apps, which meets WHO medical protocols.

The Solar Ear Apps cover the most critical times: when a baby is born (the Holy Grail in the hearing health space as 140 million babies are born every year, yet only 17% have their hearing tested), when a child joins a school for the first time and when people turn 55+ and hearing problems might start. Further to this, a Maternal Education App, Data collection App as well as using AI to have the cell phone become a hearing aid. This program will open over 100,000 new testing sites in LMIC’s, which will enable us to help the 87% unserved population and last mile consumers.

Our Smartphone Apps will be user-friendly, not require a trained audiologist, and are affordable. For example, the cost of each Solar Ear screening test will be as low as $0.10 cents per test for the testing site as opposed to existing fixed devices, which vary in cost from $5,000 to $80,000 and cost $35 per test.

The WHO is committed to partnering with us to make newborn screening part of public policy. The data from all other apps will result in the largest hearing aid study which will have value for research institutions to inform research and policymaking programs as well as for pharma organizations who need real-world data to develop new drugs to lower hearing loss.

We will make hearing health affordable and accessible for all. We estimate that the total number of people tested in LMIC countries in the first five years alone will be above 168 million people (more than 70 million of babies and children). In the long run, we want to enable universal infant hearing care, but this can only happen when the babies, infants, and children have their hearing tested and the results are submitted to their governments so that they know the size of the problem so that a longer-term sustainable solution can be implemented in their country

To reach 100,000 new testing locations, we will use an innovative yet existing distribution network such as micro-entrepreneurs, telehealth networks that reach last mile-consumers, plus hospitals, schools, mid-wives, pharmacies, nursing homes, veteran centers, optical stores, and community health workers.

Our research partners are institutions such as Cambridge University Digital Health (UK), Olin College of Engineering (US), Utah State University at their National Center for Hearing Assessment and Management (NCHAM). and McGill University (CA) as well as Global Disability Hub ( UK) and 60 Decibel (UK) 

We required funding to accomplish and validated our research project. We are also hopeful that through your Challenges with past and present participants and winners we will be able to replicate and scale our project in their country as well as expand our network and share lessons learned with them.

Our unique approach (affordable, portable and simple to use) will enable thousands of new low-cost audiology departments using a smartphone in organizations like hospitals, clinics, pharmacies, optical stores, schools, community health workers, telemedicine networks, VA centers, micro-entrepreneurs etc.

Detection is the critical first step in combating hearing loss. In developed countries, on average, there is one audiologist for every twenty thousand people. By contrast, in developing countries, the WHO estimates that there is one professional for every two to six million people. The need for more accessible hearing health solutions in developing countries is clear. Studies show that a hearing test conducted by smartphone is as accurate and quicker than one done in a professional’s office. It is also far less expensive. In Africa, smartphones are more prevalent than in the United States, while in India, a smartphone now costs as little as USD 7.50.

Solar Ear aims to bring together innovative technologies with proven protocols in the treatment of hearing loss to diagnose and resolve hearing problems. Solar Ear has developed a program, mDREET, with five main components: detection, research, education, equipment and therapy. The m stands for mobile. Portability is key to mDREET’s accessibility and success.

Each individual mDREET component has been successfully implemented and tested. Solar Ear Brazil has tested the first holistic program at its facility in Sao Paulo. Solar Ear will, for the first time, bring together mDREET’s five components using an Android-based smartphone. The fusion and interconnection of each individual program and protocol, along with key partnerships, create the solution to reduce hearing loss.

 The unique advantages of Solar Ear’s affordable and accessible mDREET program include its:

• Focus on developing countries through affordable and accessible Android-based platforms
• Language-agnostic apps that are geared to children and others with limited reading skills
• Multiple detection apps for different life stages, and 1st to start with babies
• Maternal education app, which could help prevent up to 50% of hearing loss in children Data collection, a free by-product of mDREET’s detection apps. The resulting database will facilitate one of the world’s largest hearing aid studies
• The data collection will have a catalytic effect as it will show the Ministries of Health the problem of hearing loss among babies and children in their country. There are many studies showing that is it far less expensive from a financial and human capital point of view to treat and help a child with a hearing loss versus supporting a child who will be considered deaf throughout their life.  The data will also have great value for pharmaceutical companies who are working on drugs to reduce hearing loss and or grow cochlear hair cells. Today there are few if any studies on hearing loss and the types and causes of hearing loss in LMIC's. In a similar vein our study will show if the child's hearing loss is caused from ototoxic drugs which are used to help people with HIV-AIDs but cause a hearing loss

Today there are several companies selling individual detection apps, but no one is offering, a multi-disciplinary, holistic approach  ( DREET) PLUS a variety of solutions or working on reducing hearing loss, so that one does not have to buy anything. By distributing via different distribution channels and publishing results we and others in the digital -health space can see which is the best vehicle to reach the most people in the most efficient and low-cost manner given traditional medical facilities in LMIC's are under-equipped, lack many specialists like audiologists and are under-funded

We will also find out which distribution channel is most efficient, reaches the community members in the most cost-effective  manner

If you can detect a hearing loss in a child before the age of 3 and help her get hearing amplification, she will be able to hear, therefore the ability to develop speech, and the opportunity to attend a local public school. It is only through education that can you break the cycle of poverty. So to this end and within 1 year, we will have the first hearing test for infants and children as well as finish the development of the first low cost portable hearing test for newborns. The age, location, and type of hearing loss will be a free bi- product from these hearing tests which we will share with the Ministries of Health. Over the next 5 years in an established partnership with the W.H.O., our goal is to make newborn screening and pre-school screening part of public policy.

Given the dearth of trained professionals in LMIC's  we will embark on a multi-pronged innovative distribution channel. Our pre-school hearing apps will be available at local schools, pharmacies, and rural health clinics and will be geared for a non-professional to give a professional clinical proven, meeting all medical protocols and hearing test. We will offer not only the traditional pure tone hearing test but also a Digit in Noise hearing test. This digit in noise hearing test is part of our speech-language therapy app, which takes the form of songs, books, and games all in 1 app. This app will involve the parent who will be also able to detect a hearing loss via this app when playing the games, singing the song or reading with their child. Again one cannot diminish the importance of early hearing loss detection.

From the hearing tests and using AI we will be able to remotely program the child's cell phone to become a hearing aid. Therefore when entering school the child can put her phone on her desk and hear her teacher

 Often in rural LMIC's, it is the pharmacist who acts like the local doctor. The pharmacist will be motivated to offer a hearing test for the outer, middle, or inner ear. The traditional pure-tone of the digit in noise test will just show if the child has a hearing loss, but not what part of the ear this loss occurs. a  test in the outer or middle ear will show if the hearing loss in just a temporary one caused by too much wax( outer ear) or an inner infection ( middle ear). If neither then the hearing loss is more permanent and is an inner ear hearing loss. If it is an outer ear loss the pharmacist can then sell an ear wax removal kit. If the hearing loss is due to an ear infection then the pharmacist can sell an anti-biotic. Therefore the profit motive will entice local pharmacists to sell a hearing test and in most cases a solution.

In the first year, we will be working with the John Hopkins University  Ayu telehealth project of getting our apps to the last mile consumers in India Over the next 5 years, we will expand our telehealth network and to other countries.

We are part of Ashoka's micro-finance network,This network serves over 30,000 micro-entrepreneurs in India, Indonesia, and East Africa. Their micro-entrepreneurs are presently offering health tests using a cell phone, eg Healthy Entrepreneurs. https://www.healthyentrepreneu...

In the first year, we will pilot in several countries and use a mix of different types of distributors which are mentioned above and sell at different price points a well as offer different promotional materials. With these results over the next 5 years given lessons learned, we will be able to scale globally. This will enable us to have over 100,000 new testing locations and test over 80 million babies and 60 million pre-school children. For those with a hearing loss estimated to be in the 7%-13% range of those tested, a cellphone will be their low-cost hearing aid.  Our AI program will be able to amplify the missing sounds from their individual hearing tests therefore the child can use their cell phone with earbuds to hear their teacher and get an education ( $1 a month), versus live the life of a person who is deaf. Therefore the health educational , social and economic outcomes and impact of this now integrated child can be realized.

 Our SDG Impact is focused on people with a disability. Our mission is in line with 

SGD 3- As improved hearing health is the activity, measured by # of apps sold and the number of countries which make newborn screening part of public policy

SDG 4- A child who can get hearing amplification early, can develop speech therefore the opportunity to attend a local public school

SDG-7. Today over 200,000,000 hearing aid batteries are thrown out every year. Our cell phone as a hearing aid will save over the life of traditional hearing aid 250 batteries per ear ( 50 per year)  from being thrown out. In year 5 we will have had over 800,000 cell phones as hearing aid app downloaded, which will save 40,000,000 zinc-air batteries from being thrown out

SDG 9 - Having professional hearing tests done on a cell phone and then using AI to have the cell phone become a hearing aid is very innovative. Solar Ear has won  the Duke Innovation Award, as well as UNDP Technology Award and Fast Company, named Solar Ear was one of the Top 10 most innovative companies in Brazil

SDG 10. Too many studies and reports have shown the lack of inclusion of people with a disability

SDG 17. We have partnered with the WHO to help with our advocacy program and via our data to lobby Ministries of Health to make newborn screening part of public policy. We get free advertising from Google Foundation and have received funds from Philips and Lemelson Foundation. We are in discussion with UNICEF to private label for them with our children's hearing test

 Solar Ear has a partnership with Santa Clara University, which will be doing an M& E study on our program,  in order to enhance and evaluate its social impact among children with hearing loss in several countries. Solar Ear attempts to improve the quality of life of hearing impaired individuals by providing hearing tests and then having cell phones become hearing aid. Hearing loss is prevalent in LMICs because of a lack of prevention efforts, limited access to affordable health care and treatment of diseases, and higher noise pollution levels in several employment sectors. As the severity of the problem increases, otherwise healthy children and adults are prevented from attending school or working because they are considered deaf, even if their hearing loss is not complete. Solar Ear is making large advances in bringing its hearing aid technology into lower socioeconomic sectors of a variety of countries.  Our research delivers a comprehensive report developed from both qualitative and quantitative measurements of the social impact of frugal hearing aid technologies. Through a detailed analysis of existing monitoring and evaluation tools, as well as personal interviews, we develop and analyze a new monitoring and evaluation tool (MET) reflecting our observations in the field. This new MET serves as an instrument to collect quantitative statistics on the hearing product app as Solar Ear looks to expand into other countries Furthermore, our final research concludes with an investigated review of technological means in hopes of finding a way beneficiaries could report the social benefits of the device through an IT-platform based MET rather than relying on trained interviewers or survey takers. Based on extensive research it appears there is no existing report that seeks to measure the social benefits of frugal health technology. As a whole, our report can support the ongoing operational improvement of the enterprise.  Our goal is to create a measurement and evaluation tool (MET) to quantify the social benefit that individuals receive from Solar Ear’s hearing health apps. Previous METs target the clinical outcomes resulting from hearing aids only. The previous literature has focused on the auditory improvement provided by hearing aids. For example, previous METs seek to find answers to questions such as: “When in noisy environments, do individuals with hearing aids find it easier to understand speech and maintain conversations?” The most prominent of such measures are the Glasgow Hearing Aid Benefit Profile and the Profile of Hearing Aid Benefit. Both the Glasgow Hearing Aid Benefit Profile and the Profile of Hearing Aid Benefit measure the post-intervention auditory impact of hearing aids. Although these METs are very effective in assessing the satisfaction of the hearing-aid user and minor lifestyle changes, they do not measure the social benefit of receiving a hearing aid. Our MET aims to meet this challenge by assessing the social impact of hearing aids based on key dimensions: health, self-confidence and empowerment, education, and work. These dimensions were selected because we thought they would be the most robust predictors of the improved conditions of life. An investigation of all these dimensions would provide us with a well-rounded data representation of hearing aid receivers. By using our measurement tool, alongside established measures such as those listed above, Solar Ear will be able to assess the social impact of its products. Our MET provides a more holistic measurement of the impact that can be measured by clinical measurement of auditory improvement alone.

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We aim to mitigate the effects of early hearing impairments by offering both mobile healthcare workers and those in clinics and hospitals apps which can screen a hearing loss in the outer, middle, and inner ear for children  plus a screening device for newborns 

Input- Screening device for early hearing impairment (H.I.) intervention 

Outputs - Clinics + hospitals, schools, and pharmacies purchase apps that meet their needs for secondary healthcare workers to use 

Outcomes- 

a)  Secondary health workers screen young children and identify H.I.s

b) Children with H.I.s are on track with education
c) Avg. age of detected hearing impairment decreases 

Impacts- 

a) Early intervention as a concept can be prioritized globally

b) Higher socio-econ status
c) People are lifted out of cycles of poverty

We are the first company to test the outer, middle, and inner ear using a cellphone and in 10+ languages geared for secondary healthcare workers, meeting all WHO medical protocols. From the test results and using AI developed at Cambridge University we will be able to adjust the user's cell phone to amplify all missing sounds which appeared on the audiogram from their hearing test. The hearing test audiogram, which is the results from the hearing test can be printed, send by email or SMS to either the user or to a tele-audiology network or their ENT, where the results can be read by a professional and various solutions offered

We are also inventing the first low-cost 50-80% less expensive newborn screening progarm. Low-cost newborn hearing screening is the Holy Grail in the field of audiology

Traditional equipment to test the outer, middle- inner ear plus newborns screening costs over $80,000 plus $35 per test, while the Solar Ear program will have an initial cost of under $1000 and 20 a month for an unlimited number of tests

Given we will meet all European and American Data privacy laws, we are having a third party, Cambridge Digital Health collect all data. They will get the age,  gender, type of hearing loss, some family history to determine if there is a genetic relationship to hearing loss,  postal zip code or telephone area code ( but not the number) or the name of the person who has been tested.

We will pay them on a cost per thousand data collected progarm.

Solar Ear which was started 20 years ago, was founded on the ideas, hopes and dreams of 10 women who are deaf in rural Botswana.Each Solar Ear hearing aid assembly location is independently owned and operated with 70% of the employees being deaf and the corporate language is the local sign language.

The Solar Ear digital enterprise  Executive Board (Legal, Finance, HR, CEO, MD; currently and ownership is 55% female) promotes gender diversity, strengthening and empowering our workforce. We fully support all of our employees on their journey with DSE assessments, tools, training and mentors. Our equitable recruitment, compliant with Equality Act 2010, encourages anonymised applicants to show their talent irrespective of their race, ethnicity, gender, sexuality or disability. Recruitment bias is removed by using technology-based hiring and competency-based assessment techniques. We adhere to company policies and the Equality Act 2010, welcoming all applicants. Wages are in line with roles and flexible accommodations (e.g. shared parental leave) are made. All staff receives EDI training. We offer continuous support to ensure balance and confidence among all our staff, with the work-life balance a priority. 

We will be offering a suite of apps that are appropriate and at different price points and which will differ for each distribution channel. A pharmacy, medical clinic, or optical store which wants to test the outer,  middle and inner ear will pay for an unlimited number of tests for $20 a month. If they want to add newborn screening to the mix their cost will be $36 a month

We were fortunate to have had Dr. Mohammed Yunus help us with our pricing program for micro-entrepreneurs. He explained that a micro-entrepreneur in order to be motivated to offer a hearing test must make $1 a day. Yale University did a study for Solar Ear and they determined that a micro-entrepreneur would do on average 3 tests a day. Therefore working backward it was determined that the micro-entrepreneur would sell each hearing test for $1.50  and they would make $0.33 a test or $1 a day. Their micro-finance institution would make 15%, Google Play 15%, and Solar Ear the balance. It was also explained to us that we did not have to worry if a competitor came out with a cheaper app as the micro-entrepreneur would not offer the test as they could not make their $1 a day in revenue. Conversely, if a competitor came out with an app that was too expensive the consumer would not be able to afford the test.

As is evident our success will mainly be based on the power of our distribution coupled with an easy-to-use technology that is geared toward the non-professional  

 We will engage with professional audiologists, pharmacies telehealth networks, and optical stores in developing LMIC's who would appreciate the range of hearing tests that we can offer as there is not one single application or device that can test the outer, middle and inner ear which will offer flexibility for these professionals as our 3-in-1 app solution.

 Additionally, because it is a mobile program, secondary healthcare workers can arrange to visit consumers who do not live near a testing facility, or who are physically or mentally challenged. A pharmacist having their own practice, based on hearing test results, they can sell their own remedies if this is an outer or mid ear issue.
We are currently in positive discussion with Vodafone about having these apps created on their mobiles for when clients buy
their products and looking to link up with the Vodafone Foundation in sub-Saharan Africa as a plan of collaboration in education

 The more hearing tests performed by our distributors the more money they make. In some cases, they can add hearing to their basket of mobile health apps they presently sell.  Our program widens their trading area and enables them to go to remote areas and can even go to the person's home. Too often an audiologist that has diagnosed a person with a hearing loss cannot help this person as the price of traditional hearing aids starts at $1000  Turning users’ mobile phones into hearing aid is an accessible and economical solution. Having the mobile phone as a hearing aid plus age-appropriate therapies ensures that the distributor is able to provide a more complete service.

End users are engaged at every step. They were part of a needs assessment study before any of the apps were designed or developed. All apps are geared for the consumer and not the professional, and will seamlessly interact with each other.

Furthermore, we will be conducting clinical trials with consumers, which will be published. We will also involve consumers in our pilot study in different countries and 4 different markets; the lessons learned will better enable us to successfully scale globally.
We are also developing different age-appropriate apps (i.e. for children and seniors) rather than a one-size-fits-all program. We will initially
offer our apps in 12 different languages to cater to various end-user groups. 

 Development of an algorithm that will take a user's hearing test results, and modify the auditory output of their mobile device in order to make sounds and speech more discernible.  Preparation of documentation to allow deployment and use of the mobile app with an algorithm. Under some
jurisdictions, the app will be classified as a medical device (software) and documentation will be needed to support this. As best practice, a technical file will be completed which will contain information about data security,
where/how data is kept, data retention policy, and related information.
Turning users’ mobile phones into hearing aids - 

 Additional countries will be selected for the deployment of the mobile app with amplification. These will be selected based on how similar the countries' demographics are to one of the countries selected for data set creation. In countries where multiple languages are commonly used, the app will have written elements translated into other languages (a maximum of 12 languages) to allow the app to be widely used

In some cases, pharmacists can sell solutions (e.g. ear wax removal or antibiotics) to the hearing problems they find. We will use existing pharmacy sales agencies that represent many pharmacy suppliers and work internationally. It will also exhibit at the pharmacy, telehealth, telemedicine, and MedTech trade shows. Its B2B work will include pharmacies, schools,
nursing homes, rural medical clinics, occupational therapists, veterans’ associations, NGOs, and INGOs (Rotary and Lions Clubs for
Hearing, UNICEF working in developing countries. 
Our B2B and B2C will be via Google Play or Apple Store.  Turning users’ mobile phones into hearing aids will cost $1 month., or 80% less than the monthly  cost of hearing aid batteries only !!

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As a secondary market, we could be a private label for UNICEF, the WHO and Rotary and Lions Clubs. For those living at the bottom of the pyramid will be selling via micro-entrepreneurs as well as telehealth programs like John Hopkins AYU program. Finally, INGOs like UNICEF., W.H.O, UNPD as well a Rotary and Lions Clubs serve another segment. 

 When the future development of the hearing test for newborns has been created, we can use the existing hearing aid app with
speech therapy to develop an interface for under 3s. This will allow us to approach the low-middle income countries (LMIC) that have
a low number of audiologists per population, i.e. 1 audiologist for 6 million people. Very few LMICs conduct newborn screening due
to equipment cost and not being portable. This will give babies and young children the best possible start in hearing /words. 

 Before starting this program we hired an outside consulting firm to see if in Latin America people wanted their hearing tested ( 54% responded in the affirmative)  and at what price they would pay for a solution, which turned out to be $99. The least expensive hearing aid on the market today is
Solar Ear which costs the consumer under $200 , but 99% of hearing aids sold on the market start at $1500  per ear. 

 In developing countries or remote areas of a developed one, it is almost impossible to get a professional hearing test and or solve a long-term or short-term hearing loss. In these areas, there are no audiologists or
ENTs. All free online hearing tests are unreliable due to background noise creating too many false-positive results, nor do they tell the consumer if they have a sensorial (inner ear) or conductive hearing loss (outer and
middle ear). The mobile competitor’s hardware and software are geared for professionals only which eliminates the pharmacist or secondary healthcare worker. Finally, our solution offers these customers a seamless solution, from test results to our e-hearing aids on cell phones, to age-appropriate therapy.

 By using our solution, the consumer will know what type of hearing loss they have, i.e. conductive or sensorial, and be directed to the proper solution. Our solution will also enable the consumer to get their hearing tested
and solutions offered at a pharmacy, nursing home, micro-entrepreneur, or via an NGO, or tele-audiology available in 12 languages. They will be able to use all of our apps with confidence as everything will have been
clinically trialed and received CE, FDA, and/or other approvals. 

The initial main gain for all consumers is the wide availability of locations to have their hearing tested at a low cost. Inner ear tests show a hearing loss but cannot tell the consumer if it is short-term/conductive loss or a
more permanent sensorial loss. Our tests, however, also test for outer and middle ear hearing loss; if the problem is determined to be in the outer/middle ear, they will be able to get a solution for this short-term
problem and not be required to see a professional. Therefore, they would not need to get a hearing aid, nor our hearing aid app nor require speech-language therapy as their short-term loss can be helped.

Turning users’ mobile phones into hearing aids - sensorial loss, then our hearing aid solution (at $1 a month using their cell phone and earbuds) is an
affordable and accessible solution. We will also have everything available in 12 languages or be able to connect them to a tele-audiology network if their sensorial hearing loss is more severe or profound.

We have brought money into this program in order to develop the first 4 apps the following way. The founders invested over 1.5 million of their own funds. They have also received in-kind contributions and grants from Google Foundation, Philips Foundation and Ashoka. They have received so far over 1.2 million in technology in-kind contributions from Olin, University, Cambridge,  McGill, MIT, and Yale. and will receive even more going forward, from them as well as Duke University and Georgia Institute of Technology. Often Universities develop new technologies but have no knowledge as to how to distribute this technology. They all appreciated the success and global recognition of Solar Ear in the past and all of them see us as the way to get these products under the Solar Ear brand to LMIC's. In several cases,  as with Olin, McGill, and Cambridge, the Founder of Solar Ear helps the students understand the problems ones faces in an LMIC as well as is a volunteer lecturer in their Affordable Design Entrepreneurship program or Frugal Innovation program. 

Given the development expenses are a fraction one would incur without the support from universities, we are able to sell the different suites of apps at a very low cost starting at $1 a month for a cell phone as a hearing aid app which can be downloaded on an IOS or Android phone. The only other company selling this app sells their app for $30 a month and works only on an Apple phone. 

 Solar Ear has been in the hearing aid business for 20 years and has distributors in over 20 LMICs and will now offer them our suite of professional apps. For pharmacies, optical stores, hospitals, and rural medical clinics our apps will sell for $20 a  month. 

We recently concluded a deal with a Swiss company, for $500,000 USD  who will offer our adults hearing screening test ( not the more elaborate hearing diagnostic test) for adults, for free. He has 90 million gamers in his program. His plan is to then sell advertising as part of the free download and they will give Solar Ear a 10% royalty on all advertising revenues. 

We will look to other opportunities with some of our apps to offer them for free and generate money through advertising

Given we are an app-based company our fixed overhead does not change if 1000 apps are downloaded a month or 1 million apps.

Also part of our strategy is to sell our data to pharma companies given we will have the largest hearing aid study for people living in LMIC's. We did a pilot data project with a Boston pharma company and they paid $5000 USD for 10,000 hearing test results.

Also given the data for free on our newborn hearing screening product with the goal of making newborn screening part of public policy will have long-term sales opportunities for us. For those countries where our product was used and public policy was changed, we then expect these countries to specify our product fot their health system

The original Solar Ear hearing assembly program, which enables us to start the first solar-powered hearing aid business made by people who are deaf in rural Botswana, was started with a $200,000 grant from African Development Fund. We have grown this into a 15-million-dollar organization and have scaled to Brazil, and China and will soon be opening in India. Our digital hearing holistic program was set up as a separate social business with initial seed money coming from the Founders. Since its inception, we have received in-kind contributions and in-direct funding for consultants, web site and some technology from Google Foundation's $480,000 USD annual contribution which continues today.  Philips Foundation paid for 4 McKinsey Consultants to help us develop our business plan. This consulting program lasted 6 months and we video met for 90 minutes every week for 6 months. McGill University, Olin University, and Cambridge have all given us free technical help which enables us to develop the first hearing test app for children and speech-language therapy app for children.  Showing organizations that we were able to go from making hearing aids to a digital hearing health app program enabled us to get a prepaid order of  $500,000 from a company called Swiss Consult in order to modify our children's app to one for adults. We have recently signed an agreement with ANDBANK Brazil to act as our investment Bank to help us raise 2.5 million. We are also working with a  Swiss Asset management 47heritage firm that is committed to raising $5 million dollars by the end of 2022 for a 33% equity stake in Solar Ear mobile company.

We also waiting to hear on 3 grant proposals, all of which we have made to the second stage: J &J Foundation one to the  EU, and the third  to Templeton Foundation all for our newborn and infant maternal education program which will be a free app and which social investors have shown no interest in funding as it is free.

 As each app is developed we will start selling to channels mentioned in this proposal and become sustainable with an IRR of 31%, breaking even in year 2.  Our revenue will not only come from monthly subscription fees from our different suite of apps, but also from selling the data