Daily Archives: September 18, 2014

Clinical trials of cochlear implant to begin soon

CochlearTELANGANA18sept2014

The indigenously-designed and developed low-cost implant is expected to be ready for commercial production in a year. A host of DRDO labs are involved in the project-NSTL, NMRL, Anurag, RCI and DIPAS, besides the Armed Forces Medical College and Andhra University.

An indigenously-designed and developed low-cost cochlear implant is expected to be ready for commercial production in a year with clinical trials set to begin in the next few months.

An application seeking permission for clinical trials has already been filed with the Drugs Controller General of India (DCGI) on behalf of the Society for Biomedical Technology (SBMT) and clearance is expected in a couple of months, said V. Bhujanga Rao, Director-General (Naval Systems & Materials), Defence Research and Development Organisation.

A host of DRDO labs are involved in the project-NSTL, NMRL, Anurag, RCI and DIPAS, besides the Armed Forces Medical College and Andhra University.

Talking to The Hindu here on Wednesday, Dr. Bhujanga Rao, who is the chief designer and principal investigator of the project, said the cost of the indigenous implant named ‘Sravan’ would be between Rs.1 lakh and Rs.1.5 lakh as against an imported device that could be between Rs.7 lakh and Rs.8 lakh.

Cochlear implant, also called ‘bionic ear’, provides hearing perception to people suffering from profound hearing loss.

Bio-compatibility tests completed

With successful completion of bio-compatibility tests, he said multi-centric clinical trials across the country would be conducted for about six months to one year after receiving the nod from DCGI.

They include Post-Graduate Institute of Medical Education and Research, Chandigarh, Armed Forces Medical College, Pune, Army Hospital Research and Referral Centre, Delhi, Sri Ramachandra Medical College and Research Institution, Chennai and Apollo Hospital, Bengaluru. He said some private practitioners from Delhi and Bengaluru would also be involved in the trials.

He said the implant developed in India would be the world’s cheapest, without compromising on quality.

After the successful completion of clinical trials, the technology would be transferred to an Indore-based company for series production.

Technology can be shared

In case the volume becomes high, the technology could be given to more companies. He said nearly one million people in the country suffered from profound hearing loss, while every year 10,000 infants are born with the same problem.

source: http://www.thehindu.com / The Hindu / Home> News> Cities> Hyderabad / by Y. Mallikarjun / Hyderabad – September 17th, 2014