BrainChild Tech - Accessible infant hearing screening

Hearing loss during a baby’s first year can disrupt a critical window for language development. Unfortunately, relatively simple and effective interventions are limited by the difficulty in identifying hearing loss at this early age. Because an infant cannot tell you if they hear a tone, providers have to rely on expensive medical devices that are often limited to a specialist’s office.  The cost of these devices make newborn hearing screening out of reach for many low- and middle-income countries, and even high-income countries still miss half of the cases of early childhood hearing loss. We are increasing access to regular hearing testing by creating the first low-cost, behavioral assessment of hearing for infants.  By reducing the reliance on expensive hardware, we are increasing access for everyday caregivers so that the 7.5 million children with early hearing loss have a chance at their best language outcomes. 

As the first year of an infant’s life is a critical window for language development, an unrecognized hearing loss can lead to lifelong language and cognitive deficits. Hearing loss is also one of the most common disorders at birth (2-6 in 1,000 infants), leaving ~750,000 infants worldwide born with hearing loss, and a total of 7.5M children from 0-5yo. Receiving an intervention, such as a hearing aid, before 6 months is an effective way to improve language outcomes. Unfortunately, implementation of these relatively simple interventions is limited by the difficulty in identifying hearing loss at this early age. Because an infant cannot tell you if they hear a sound, we instead rely on expensive medical devices that can only measure some aspects of auditory function. These devices have enabled universal newborn hearing screening programs in higher-income countries; however, their costs make them inaccessible for routine monitoring in the medical home and low- or middle-income countries. Even in the US, about half of early childhood hearing loss (8,000-10,000 cases) is missed by newborn screening. With the current technology, there is a large gap in hearing screening between birth and 4yo, exactly when a hearing loss has the greatest impact on language.

Our solution is relevant for all families as hearing screening is a regular part of developmental surveillance for all infants. More specifically, we hope to improve access to hearing screening for families who currently struggle to reach an audiologist and existing hearing screening devices. This will include families in countries that cannot afford the devices needed to implement a universal newborn hearing screening program. Even in countries with existing screening programs, this will assist the 30% of families whose infants are identified by newborn hearing screening, but who are lost to follow-up before they can receive a timely diagnosis and intervention. This can include families in rural areas, those that struggle to take time off of work for multiple appointments, or those with transportation or resource constraints. Finally, this will also improve outcomes for the 10% of all infants with a risk factor for late-onset or progressive hearing loss who will not be identified by newborn screening and therefore are missing out on simple and effective interventions.

Detecting hearing can be challenging in infants as they have few behaviors to control in order to express what they hear. Before infants can talk or gesture, researchers will sometimes measure an infant’s looking behavior in order to infer what an infant is thinking, however even this measure is not possible from birth. One of the few behaviors a baby can control from birth is their sucking reflex, and just like looking behavior, a baby will naturally change this behavior when something catches their attention. Audiologists have learned to watch a pacifier in response to sound for hearing tests, and researchers in baby labs have a long history of wiring up a pacifier to more objectively measure an infant’s responses to images or sounds. 

We have created an accessible version of this established research tool with our low-cost smart pacifier. It measures a baby’s sucking behavior and allows them to control sounds or images on a connected device (similar to a remote control or accessibility device for an infant). The pacifier can control multiple software applications, starting with a tablet-based audiometer that measures an infant’s responses to sounds for hearing screening. Similar applications could also measure an infant’s responses to images to identify visual impairments, spoken language for speech and language delays, or response to faces for social attention in autism spectrum disorder. Together, providing this accessible and objective measure of infant behavior will help improve the data on neurodevelopment across diverse populations. 

For hearing, our platform will be the first objective behavioral assessment of hearing for the important age of 0-12months. A behavioral assessment is the gold standard to test hearing, but this is not currently possible until 6-10months when audiologists measure how a baby turns their head towards sound. By measuring sucking behavior instead of head turning, we open up these behavioral assessments during this existing gap from 0-10months. Not only will this improve the quality of hearing assessments, but it will also eliminate the need for more expensive devices that instead rely on a physiological measure of auditory function. Existing hearing screening devices cost between $4,000-$30,000, in addition to yearly calibration costs, while our hardware has an estimated materials cost of $10-15, leaving flexibility on the final price point.

Our pacifier platform opens up a new area of opportunity to communicate with infants in order to understand neurodevelopment. The first year is a critical window for neurodevelopment, however it is difficult to study as infants have few behaviors to communicate their internal experience. Alternative communication tools like sign language have revealed that infants have complex language skills even before they are able to express them through speech.  At 8-9mos, an infant can begin to express themselves with sign language. Before sign language, they can control the turning of their head towards something that interests them. Before head turning, they can control their eye gaze and looking behavior, but even this is not possible til 2-3mos.  Before any of these behaviors, an infant can control their sucking behavior as this is one of the few behaviors they can control from birth. Our pacifier platform is essentially one step before sign language so that infants can express themselves even before the have other motor coordination.  

Our pacifier platform can provide multiple applications with one piece of hardware.  It can help caregivers assess infants’ responses to stimuli for developmental assessments, support back-and-forth communication for early education and intervention, and also serve as a research platform to collect more data on neurodevelopment in more diverse populations.  Creating a low-cost, at-home version of this flexible research tool provides opportunities for innovation in data collection for diverse populations and can lead to a better understanding of the trajectory for more complex neurodevelopmental disorders. 

We are creating a smart pacifier that measures infant’s sucking behavior and allows infants to control images or sounds on a connected device. For applications on hearing, the smart pacifier connects to software that controls an audiometer in order to present the controlled sounds of a hearing test. This platform is based on innovations to two existing techniques: Behavioral Observation Audiometry (BOA) and High Amplitude Sucking (HAS). BOA describes how audiologists watch an infant’s pacifier in order to gauge an infant’s behavioral response to the sounds of a hearing test. HAS refines this technique by creating a passive and contingent version, where infants can control the presentation of stimuli with their pacifier. The HAS technique has been used in developmental psychology laboratories since the 1960’s and relied on a hardware set up that could not pass consumer safety testing for pacifiers. We have updated this existing research tool so that the platform can fit within consumer safety testing, be used safely by an infant, be low-cost, and connected to flexible software applications.

We expect our solution to improve access to hearing screening because of the reduced hardware costs of our platform compared to the existing solutions. The current assessments of hearing in infants rely on Otoacoustic Emissions ($4,000/device), or Auditory Brainstem Response ($15,000-30,000/device).  Because of the cost of these devices, they are typically limited to either central medical centers that see a high volume of infants, or specialist offices that focus on hearing. This has enabled success of newborn hearing screening programs in high-income countries as birthing hospitals can afford to invest in these devices and screen all infants while they are already at the medical center. However, gaps in identifying hearing loss are in part due to the difficulty in accessing these devices once infants leave the hospital. In the U.S., families in rural areas may not be able to reach a pediatric audiologist after birth and are often lost to follow-up.  In low- and middle-income countries, a higher percentage of parents are giving birth outside of a central medical center, and so there is a greater need for devices that can feasibly have a wider distribution.

By providing a lower cost platform, we can expand access to rural populations and low- or middle-income countries.  Pilot studies have suggested that universal hearing screening programs in low- and middle-income countries would need to be less than $7/infant, and we anticipate being well able to meet that threshold. 

We are currently in development and not actively serving any infants. We expect pilot tests and clinical trials in the next 1-2 years, and a launching of the product within the next 5 years.

Currently serving = 0

Expected in 1 year = 50 infants

Expected in 5 years = 400,000

Our goal in the next year is to conduct pilot studies in order to finalize the design of our hardware and initial software. We will then be conducting a larger clinical trial in order to compare the efficacy of our platform to existing hearing loss technologies. At the same time, we will be refining our regulatory strategy for this platform through Pre-Submission meetings with the FDA in order to build to any regulatory submissions.  

In the next five years, we aim to gain wide distribution among the small niche market of pediatric audiologists. We will be expanding beyond the clinical setting as a screening tool for early intervention home visits and at-home monitoring for infants with a risk factor for late-onset hearing loss (400,000 infants in the US).  Within the next 5 years, we also aim to pilot test our solution for applications in universal newborn screening in a low- or middle-income country. 

Access to funding is always critical to reach our goals.  As our platform includes a hardware component, as well as need for regulatory approvals before gaining revenue, access to funding will be crucial to our success. While we have access to considerable funding through government SBIR grants, these funds cannot be used for certain expenses, such as intellectual property, manufacturing, or marketing. We will need additional funding to supplement these grants in order to reach our goals.

We will also need the right connections and champions in early childhood interventions to deal with a complex market landscape for this product. Platforms for hearing screening require a medical investment for an improved educational outcome, and the payers for these programs can vary widely between each country and state. The implementation of newborn hearing screening has demonstrated the feasibility of similar efforts, and we may require similar national-level policy support in order to gain wide distribution.  

Our platform will also need to meet certain regulatory requirements in order to gain traction, including consumer safety requirements for pacifiers, and FDA or CE approvals for any health-related claims. 

For funding, we plan to fulfill the majority of our funding needs through upcoming government SBIR grants. We have successfully received Phase I SBIR grants from the NSF and NIH in the past and have the opportunity to apply for larger follow-on grants in the near future. This additional $750k and $1M will allow us to fund the majority of our research and development needs. For funds that cannot be covered by these grants, we plan to apply for other small grant opportunities, as well as planning an equity raise in Spring of 2020.

To gain impactful partnerships, we have been connecting with innovators in early childhood through our involvement in networks like Promise Studio’s Early Futures and presenting at the National Head Start Association Early Childhood Innovation Summit. We are also building relationships with providers at 3 children’s hospitals (Seattle Children’s, OHSU Doernbecher, and Children’s Hospital Los Angeles) as the winner of the 2019 Cambia Grove TRAILS competition.

For the regulatory challenges, we have already demonstrated that our pacifier design can pass consumer safety standards as part of our previous NSF grant. We are currently working with a regulatory advisor as we work towards FDA approvals, and plan to begin our product within a 510k Exempt application. 

We currently have 1 full-time founder (Dr. Carly Kiselycznyk), and 1 part-time founder (Anke Karabanov).  This team is complemented by contractors in hardware and software, including mechanical, electrical, and software engineers. We also work with pediatric audiologists as we conduct our pilot testing in infants. We have two expert advisors consulting on this project with expertise in the pacifier measure for audiology, as well as developmental psychology research. 

The main challenge of this innovation is how to elicit behaviors from infants that are meaningful and easy to measure. Dr Carly Kiselycznyk has expertise in this area with her extensive background in behavioral neuroscience. Her academic career focused on how to measure behaviors in order to make inferences on an individual’s underlying neurobiology and thought processes.  Dr. Kiselycznyk has served as the Principal Investigator on two awarded federal grants related to this technology. She is joined by Dr. Anke Karabanov who also has a background in neuroscience and has expertise in signal processing.  This founding team is complemented by expert consultants in using a pacifier measurement in audiology and developmental psychology.

We currently have relationships with Promise Studio’s Early Futures and OpenIDEO’s network of innovators and mentors in early childhood.  Additionally, we are building relationships with Seattle Children’s Hospital, OHSU Doernbecher Children’s Hospital, and Children’s Hospital Los Angeles as the winner of the 2019 Cambia Grove TRAILS competition. 

We plan to enter gain traction by initially marketing a diagnostic-grade version of our platform to pediatric audiologists in private practice or hospitals (1,000 U.S. practices). This will provide audiologists with an increased quality platform, shorter appointments, reduced time spent on data entry, and an alternative to risky and costly sedation in infants. The hardware will be sold to the audiologist practice as a one-time purchase, while the pacifier-connected software and data sharing platform will be sold as a monthly license.  Providers can then receive reimbursements either through state screening funds, Medicaid, or private payers. These audiologists will then refer infants to local services, including early intervention, where the infant’s hearing will continue to be monitored in their medical home. We will grow to this medical home market with a surveillance-grade version of our platform that can be prescribed to each individual child (400,000 US infants with risk factors for hearing loss). This home use device will help caregivers regularly monitor their infant’s without the need to regularly travel to an audiologist hours away, avoid sedating an infant, and also better evaluate hearing aids. For the home-use market, our platform can be funded as part of the child’s IFSP through state or IDEA Part C funds or prescribed by a provider and funded through Medicaid or a private payer. We can then continue to grow as a consumer-grade, over the counter device so that all families can track their infant’s hearing in their home (4,000,000 US infants).

We are currently funding our research and development through federal SBIR grants and have the opportunity for follow-on funding of $750k from the NSF, and another $1M from the NIH. Additionally, we plan to raise an equity round in Spring of 2020. 

While our product has many potential applications, it can have the greatest impact as a platform to detect hearing loss. This application, however, involves regulatory hurdles and FDA submissions that can lead to a long path to financial sustainability.  We have identified a strategy to de-risk this long path to revenue by identifying revenue streams with a reduced regulatory burden.  Our current prototype has the potential to gain revenue as a research platform for academic laboratories.  We can also gain revenue by selling the pacifier hardware on its own as an assistive technology and this would not require time-consuming software development. For hearing tests, applications in the audiologist’s office is likely considered a Class II, 510k Exempt device and so will not require a lengthy regulatory approval process. 

We are excited about the potential connections and collaborations Solve can provide, particularly for early childhood in low- and middle-income countries. We are still a small team and actively working to grow our network of advisors and partnerships as we move forward in development. Additional access to funding will also have a high impact for our team at this stage and even small amounts of capital will be impactful in our success. 

Regulatory advice

Revenue models in healthcare

Sustainable business models in low- and middle-income countries

We are excited about our potential to bring newborn hearing screening to low- and middle-income countries and would benefit from partnering with experts in this area. In particular, we’re looking for connections to experts in creating sustainable business models for implementing health solutions in low- and middle-income countries.

We are also looking for connections to funders who are interested in technologies in both the regulated medical device space, as well as consumer digital health.

Finally, we are excited for the potential to grow beyond hearing screening and take advantage of the potential to create valuable datasets on neurodevelopment in diverse populations. We would welcome partnerships with leaders in data science. 

Our goal is to create an accessible version of an established research tool used to understand infant neurodevelopment. The pacifier platform is essentially a tool to objectively measure an infant’s responses and attention to any image or sound and can relate to hearing, vision, language development, or social attention. By providing this research tool in the home, we can expand data collection to diverse socioeconomic groups and health conditions, as opposed to basing our understanding on the handful of infants who live near an academic research lab. Our platform will also enable longitudinal measures of neurodevelopment in the the baby’s own home to track changes in language and cognitive development over time.  We plan to leverage artificial intelligence in order to better understand the patterns of early behaviors that predict an eventual diagnosis of a neurodevelopmental condition, such as autism or adhd.

Additionally, artificial intelligence will help us improve the platform for each individual user’s experience. Our goal is to create an engaging platform for infants where they can learn how their actions on the pacifier leads to an outcome. As their ability for more complex interactions may change with their development and experience, we are looking at how to have a continually adapting platform that becomes more complex as the infant matures.   

 We would use this funding to hire staff in advanced computing techniques in order to build in the framework for these more advanced applications. 

We aim to help mothers better advocate for their infants by providing them an objective assessment of their infant's hearing. Most primary care providers rely on parental concerns on hearing in order to refer infants for an audiological assessment. Our platform will provide mothers with an objective measure of hearing that they can bring with them to well-child visits. Additionally, we are improving access to health records related to their child's development so that they always have access tho their infant's infant hearing screening results while communicating with various health and education providers. Finally, our platform will help streamline the process to have their infant assessed for hearing loss, and help reduce the burdensome appointments to reach an audiologist. Currently, completing a diagnostic hearing assessment may require long travel to reach an audiologist, a 3 hour appointment that may have to be rescheduled if a child is not cooperative. 

Our goal is to create an accessible version of an established research tool used to understand infant neurodevelopment. The pacifier platform is essentially a tool to objectively measure an infant’s responses and attention to any image or sound and can relate to hearing, vision, language development, or social attention. By providing this research tool in the home, we can expand data collection to diverse socioeconomic groups and health conditions, as opposed to basing our understanding on the handful of infants who live near an academic research lab. Our platform will also enable longitudinal measures of neurodevelopment in the the baby’s own home to track changes in language and cognitive development over time.  We plan to leverage artificial intelligence in order to better understand the patterns of early behaviors that predict an eventual diagnosis of a neurodevelopmental condition, such as autism or adhd.

Additionally, artificial intelligence will help us improve the platform for each individual user’s experience. Our goal is to create an engaging platform for infants where they can learn how their actions on the pacifier leads to an outcome. As their ability for more complex interactions may change with their development and experience, we are looking at how to have a continually adapting platform that becomes more complex as the infant matures.   

 We would use this funding to hire staff in advanced computing techniques in order to build in the framework for these more advanced applications.