DRDO to seek approval for clinical trials for bionic ear

New Delhi: Bionic ears, or artificial hearing devices that are partly implanted under the scalp, could be made in India in the near future, bringing down their prices by nearly a sixth and benefiting thousands of people suffering from significant hearing loss.

India’s Defence Research and Development Organisation (DRDO), which developed these devices, has completed two-year-long tests to ensure the human body does not reject these implants. It will seek approval from the Drug Controller General of India (DCGI) this month to carry out clinical trials, before starting commercial production.

The bionic ear, or cochlear implant, picks up sound, converts it into electrical energy and feeds it to the auditory nerve which goes to the brain, which perceives it as sound. The cochlea is the auditory part of the internal ear.

Though the first cochlear implant was approved by the US Food and Drug Administration in 1985, the prosthesis is still not affordable for most, especially in developing countries.

“DRDO will produce a bionic ear which will not cost more than ₹ 1-1.5 lakh, and will be the world’s cheapest cochlear implant,” said Bhujanga Rao, director general (naval systems and materials), DRDO. “With the help of philanthropists and governments, the prices can come down further,” he added. More than 3,00,000 people across the world are already using such implants, as against 5,000 in India, according to Rao.

“The final results will be out after eight months to one year, after which production can begin. The observation will take time as a person needs to be given time to heal after the surgery for implantation of the device,” Rao said.

He added that it has been decided that 50 people will be part of the clinical trials, five in 10 centres, overseen by ethical committees. The final details are still being worked out.

“A doctor once told me, for every implant that he is doing, he is turning away 100 patients. That is the gap in demand in India,” said Rao. More than 90% of the market for cochlear implants is cornered by three companies from Australia, Austria and the US, and the implants sold by them cost ₹ 6 lakh and above, said Rao.

Cochlear implant surgeries are state funded for children in European Union countries and the US because of the high cost. In India, there have been a few attempts by some state governments to make these expensive surgeries free for the poor or be financed through insurance schemes in designated government hospitals. In 2009, the health ministry had issued a notice saying that it would reimburse as much as ₹ 5,35,000 for cochlear implant surgeries of children, but only after it is approved by a standing committee of experts.

Lack of awareness, even among people who can afford the expensive procedure, is also a hindrance, experts say.

“The problem, however, is not restricted to affordability, but lack of awareness, lack of early diagnosis and groundwork. Even parents who can afford these implants for these children often do not know about the available options, or they are too late in getting the implant,” says Sheelu Srinivas, a surgeon with Fortis Hospital in Bangalore. “Statistically most of the children in India get cochlear implants after they turn five years old by which time most of the cerebral growth is over, but cochlear implants can only be effective if they are implanted in a child till she turns two.”

The device is usually implanted before a child turns two, as the brain has a tendency to slowly disable the audio cortex from functioning in the absence of sound stimulus. Conventional hearing aids can only help those suffering from mild hearing loss.

“Cochlear implants also involve a lot of signal processing, irrespective of the language. The brain has to understand all languages. We have to make a common brain language using signal processing,” said Rao, who is also a distinguished scientist. “This implant can enable a person to hear frequencies ranging from 100Hz to 8kHz, which can include telephonic conversation, normal speech to loud music,” he explained.

The cochlear implant developed by DRDO will be manufactured by Pacetronix, an Indore-based firm that makes pacemakers. So far, 50 bionic ears have been made for DRDO’s biocompatibility tests.

“There are some materials the body can accept; we have to use medically graded materials only. There are also some processes, such as welding and joining, through which we introduce foreign materials inside the head. These have to be accepted by the body,” said Rao, explaining these tests.

“This month, we are submitting the documentation for biocompatibility tests, design, advice to doctors and reliability studies to the DCGI. We will seek approval for multi-centric clinical trials, and if we get approval, clinical trials can start in the next three to four months,” Rao said.

The DRDO’s unit which developed the device has done much work in the area of signal processing. Two years ago, former President A.P.J. Abdul Kalam had announced that the cochlear implants would enter clinical trials that year, but was delayed due to biocompatibility tests.

On 20 August, Prime Minister Narendra Modi had criticized DRDO and asked it to complete its projects sooner to put India ahead in the world, Press Trust of India had reported. India is left behind in defence research because products which are “two steps ahead” come into the market even before India conceptualises a system, PTI quoted Modi as saying.