Project Lead(s): Nitin Sisodia
Issue
Half a million hearing-impaired babies are born every year globally, with 100,000 of these cases in India.
In resource-poor settings, hearing impairment often goes undiagnosed until the child is about three years, leading to speech loss and impaired communication.
Solution
The project team has developed Sohum, a screening device that uses brainstem auditory evoked response (ABR) technology, which is the gold standard in auditory testing.
The approach uses low-cost hardware and software that performs with high sensitivity and high specificity in noisy settings, and an electrode system that is easy to clean and is non-disposable, resulting in a lower cost per test.
Sohum takes less time, as it checks both ears at the same time, which makes it ideal for mass screening; it does not require trained personnel to operate.
The plan is to implement screening through pediatricians, maternity homes and vaccination camps, which already have access to newborns.
Outcome
A prototype of the screening tool has been developed and clinical trials have been successfully conducted on subjects to validate the functioning of the hardware and software.
The detection algorithm was used with 65 ABR recordings from newborns and compared with results from an assessment of the ABR waveforms by an audiologist.
Compared with audiology findings, the algorithm had a sensitivity of 98.25% and specificity of 90%.
The project was selected as a Laureate by the Rolex Awards for Enterprise, and Rolex is providing support to implement the awareness cycle and clinical evaluation of the product. The Biotechnology Industry Research Assistance Council (BIRAC) has provided a biotechnology ignition grant, which is providing support to do electrode system detailing and algorithm evaluation.
Knowledge of the project has been widely disseminated in conferences, including at the World Health Organization (WHO) international medical device conference.
There are plans to scale Sohum through collaboration with private partners and government bodies.
The team has established partnerships for product testing and clinical trials, manufacturing, marketing and distribution, and global scaling, with the vision to save the speech of millions of babies born with hearing loss.