Sohum Hearing Screening Device

Distributors / Implementing Organizations

Sohum Innovation Lab, All India Institute Of Medical Science (AIIMS), St.John's Medical College Hospital, Childrens Hospital in Hyderabad, Union Ministry of Science and Technology

Manufacturing/Building Method

Sohum Innovation Labs developed the Sohum hearing device prototype, which was launched for use in 2017 by the Union Ministry of Science and Technology. They are manufactured in India, and meet ISO 13485 standards.

Intellectural Property Type

Patent Protected

User Provision Model

The device will be made available to Public Health Centers by the government. Healthcare workers will conduct screenings of neonates, and children testing positive for hearing loss will be connected to Sohum-certified audiologists for further care.

Distributions to Date Status

Unknown

Design Specifications

Sohum uses brainstem auditory evoked response (BAER or ABR) technology for testing. The device checks both ears simultaneously, is non-invasive, and doesn't require sedation. It can filter out clinic ambient noise from the test signal, and is battery operated.

Technical Support

Unknown, still at prototyping phase

Replacement Components

Batteries

Lifecycle

Unknown, still at prototyping phase

Manufacturer Specified Performance Parameters

This hearing screening device was designed to measure auditory waves via three electrodes placed on a baby's head, filter out health clinic ambient noise, be non-invasive, be user-friendly for clinics in low-resource settings, and be low-cost and portable.

Vetted Performance Status

ISO 13485 certified, Clinical trials performed on adults, testing at five clinical centers

Safety

Unknown, still at prototyping phase

Complementary Technical Systems

Battery operated

Academic Research and References

Compliance with regulations

The device is certified by the Ministry of Science and Technology and ISO 13485 standards.