A newborn and infant hearing screening test using a smartphone-based device to detect otoacoustic emissions (OAE) showed a high level of agreement with conventional devices, based on new data from a cross-sectional study presented at the at the Pediatric Academic Societies (PAS) 2026 Meeting.

Most high-income countries universally screen newborns for hearing loss before 1 month of age, as many negative effects can be mitigated with early diagnosis and intervention, said lead author Emily R. Gallagher, MD, MPH, an associate professor at the University of Washinton, Seattle, in an interview. 

By contrast, few newborns in many low- and middle-income countries undergo hearing screening because of cost and lack of access to equipment, although the risks of hearing loss are much higher, Gallagher said. 

To help address inequity in hearing screening, Gallagher and colleagues developed a low-cost, smartphone-based hearing screening tool that uses a smartphone app and hardware that connects to the phone. The device detects whether the inner ear can respond to sound without the patient’s active participation, which makes it ideal for infants and young children, although it can be used in patients of any age, she said.

After proving the feasibility of the device to screen as effectively as a conventional OAE device in a quiet environment in Seattle, the researchers studied the device in Kenya to evaluate the feasibility in different clinical settings (a postnatal ward at a busy public hospital in Nairobi, a well-child clinic at the public hospital, and a community-based well-child clinic in Nairobi), and the feasibility for a range of users, including audiologists, nurses, and community health workers. 

In the Kenya study, the researchers compared data from smartphone-based and conventional OAE screening in 60 ears of infants aged 0-12 months. The completion rate was 100%, with 87% agreement between the results of the two screening types. In addition, a total of 153 ears of infants were tested for interrater reliability with similar results — a 96% completion rate and 83% agreement between users. 

The researchers were encouraged by the high agreement between the smartphone and conventional OAE devices in different clinical settings and when administered by various users.

“We believe that the smartphone-OAE is a very promising tool for hearing screening, that it will be useful in different clinical settings, and that non-specialist users will be able to use it successfully with minimal training,” Gallagher said. 

The research team intends to commercialize the device and make it accessible at low cost in areas where it is most needed, she said. Ideally, the device will allow many areas that previously lacked newborn screening to create these programs, and also screen toddlers, school-aged children, and any individuals who are at increased risk of hearing loss. Even in high-income countries such as the United States, many primary care providers lack an OAE in the office because of the cost, she said. 

Looking ahead, Gallagher and her team are seeking funding for research on how to optimize the device for noisy environments. “One of the limitations from our study was that we could not control the ambient noise in different settings in Nairobi,” Gallagher said. “We have many ideas about how we can improve the technology so that the device will work well in the presence of noisy backgrounds, including noises around the baby or coming from the baby, such as baby movements, breastfeeding, or vocalizing,” she explained. 

The researchers hope to incorporate these changes and work with more health ministries to develop plans for universal newborn hearing screening, she said.

Good News for Low-Resource Settings

The current study builds on the researchers’ previous work and demonstrates a low-cost, readily available way to provide hearing screening to more children in diverse settings, said Tim Joos, MD, an internist and pediatrician at Neighborcare Health in Seattle, who was not involved in the study. 

“The smartphone otoacoustic emissions test performed by a nonspecialist had only slightly lower accuracy compared to the higher-priced traditional testing and could replace other screening methods in low-resource environments, said Joos. “Whether the smartphone is a cost-effective approach to hearing screening in more well-resourced settings is yet to be determined.” 

The research in Kenya was supported in part by the National Institutes of Health/National Institute on Deafness and Other Communication Disorders. The researchers had no financial conflicts to disclose. Joos had no financial conflicts to disclose.