This is said to be the first cochlear implant produced in India.
It was approved by the Central Medicine Standard Control Organization (CDSCO) in May 2021.
However, some surgeons and cochlea implant associations have raised questions about safety and effectiveness because new devices do not have publications about performance or safety in peer review journals and have no agreement on any other country.
New implants, called Neubio Bold, should be a product of the transfer of technology from Swiss Company Neubio AG, founded in 2017, to Switzneubio ARM India, founded in 2019.
Even though it is a Swiss company, the product is used both in Switzerland or anywhere in Europe.
One of the company’s directors, Khurana Parveen, in response to Ti’s request, said the company had submitted approval in Europe.
In accordance with the classification of CDSCO devices based on risk, cochlear implants are class D devices, which are at high risk of surgical implant devices that will remain in the body for at least 30 days and can be removed only through medical or surgical intervention.
CDSCO, when contacted, said they had well-determined rules and that medical devices were approved subject to compliance with these rules.
The company admitted to the cochlea implant group in India, the largest cochlear surgeon association, that the implant was only approved in India.
CDSCO approval to the device can be provided without a clinical investigation if it is based on approved devices that already exist in the market with similar intended use, construction materials and design characteristics.
Companies must build substantial equality with such “predicate devices” in connection with intended use, chemical composition, manufacturing processes, performance, security, effectiveness, etc.
In this case, no one is available in the public domain or to the surgeon.
Neubio’s Switz said implant components were produced in Switzerland and sent to India to be assembled, with only electrodes made in the Gurgaon unit, which had been checked and approved by CDSCO.
He claimed that around 300 devices were implanted in Pakistan and Iraq.
Anekdot, the results are very good, the company said, added that there were no side effects.
The company said it was intended to collect data from these countries and conduct research and produce data to be published in the journal peer review.
“Even the cochlear implant system studied by Drdo himself, Sravan, underwent a clinical trial that was approved by DCGI, as we use.
When we book with our own products, how this new device gets a license from CDSCO,” said President Cigi Sunil Narayan Dutt .