Professor Graeme Clark: Bionic Ear is Hear to Stay

Professor Graeme Clark, pioneer and inventor of the groundbreaking hearing device, the Bionic Ear, speaks with Wealth Creator about the inspiration, difficulties and progress that has spanned the past thirty years.

For most inventions there is one tipping point, when the idea comes to life and the rest becomes history. For the bionic ear it was on a sunny day at a beach in the summer of 1977, when Professor Graeme Clark was on holiday in New South Wales. Inspiration came in the form of a few blades of grass, which Graeme curled and put into a seashell.

The resemblance of the shell to the human inner ear alerted Graeme to the final piece for his lifelong puzzle – to build a cochlear implant – to help the deaf hear again. The tiny wires of the implant, just like the blades of grass in the seashell, would have to be built with progressive stiffness so as to pass around the tightening spiral of cochlea.

This and his other revolutionary speech discoveries, led to the first implant device that uses electronic technology to influence the central nervous system physiologically. Where previously the deaf and hearing-impaired had relied on signing and hearing aids, the bionic ear gave them the closest substitute for near-normal hearing.

The bionic ear operates on the basis that our everyday, complex speech can be broken down into frequency bands and represented with electrical signals. These are decoded by the implant, which then generates the appropriate electrical current to the many electrodes positioned in the inner ear structure known as the cochlea. The pitch and volume of the sounds are determined in this process. Once the cochlea nerves pick up these patterns of stimulation, the brain interprets them as meaningful sounds.

The first prototype was implanted in Rod Saunders in 1978. It was an unforgettable moment for all involved when Rod could hear again. Today, the bionic ear is much improved from its initial prototype, thanks to research and technological advances in the last couple of decades. The device developed by Cochlear Limited has benefited 70,000 children and adults alike in more than 70 countries, and in economic terms it saves the country about $600,000 per person.
 
It has not been a smooth road. Like many, entrepreneurial endeavours, the bionic ear has jumped many hurdles.

For the love

Back in 1966, Professor Clark read in an American science paper that electrical stimulation to the ear gave one deaf patient the perception of some simple sounds. At the time, the professor was a partner in an ear, nose and throat practice in Collins Street, Melbourne, having specialised in  this area at the Royal National Throat Nose and Ear Hospital and the Royal College of Surgeons in London. Working at the practice made Graeme realise how little at the time could be done to help someone who was profoundly deaf.

Inspired by the article, Graeme left the well-paid practice for an insecure research position. “I had this burning desire to do research. It was addictive. So I left the practice to become a poor PhD student at the University of Sydney. At the time, 99% of the scientists of the day said an implant was not possible,” he says. “I wanted to find out for myself.”
Graeme says his idea for a bionic ear received a sceptical reception, because the scientific community in Australia, in general, was not ready to take on pioneering inventions like this one. “When I started 34 years ago in medicine, the prevailing attitude was ‘let the Americans and others try these things first, and then afterwards we’ll work on it’.”

Yet, Graeme wanted to pioneer the research in Australia. “I couldn’t see why Australians couldn’t do things as well as any other country. I was not trained scientifically in any other country than the Department of Physiology in the University of Sydney. It was the best physiology department in the country, and one of the best in the world. I had the advantage of doing all the work here in Australia.”

He admits that there were mixed feelings. “People overseas didn’t take any notice. So whenever I was writing on the subject, it somehow nullified any competition because people thought it wouldn’t work,” says Graeme.

Much of the scepticism was also directed toward the practical side of the research. “The big argument in the late ’60s was that the only possible way to do it was to use a single electrode and try to make speech resonate with the nerves in the brain,” tells Graeme. But he thought this was actually contrary to the physiology of the human ear.

Perhaps such doubts are better understood given the context, when the most basic technology was difficult to obtain. Advanced electronics were needed to create a bunch of wires, each with electrodes on the end, which measure as little as 1 millimetre wide combined and would provide the complicated pattern of electrical stimulation required for good hearing. Not to mention that these are to be implanted in a delicate human organ such as the ear, and the body’s rejection of the implant could cause real harm to the patient such as meningitis.

Graeme persevered. His desire to help the deaf dates back childhood and his hearing impaired father. “That was crucial because even as a ten-year-old, I was well aware of the disability. I worked in his pharmacy. It was embarrassing when people would come into the shop, and Dad couldn’t hear very well. He’d say ‘speak up’, and they wouldn’t shop with him. I also know how difficult it was at home when my mother entertained, and he couldn’t always fit in.”

Money talks

Working at his father’s pharmacy and assisting him with his optometry, as well as helping out a local doctor at a young age, gave Graeme a real introduction to medical science. He was also impressed with scientific innovations and achievements early on, particularly those of Louis Pasteur. His numerous academic qualifications, which include Bachelors of Medicine (MB) and Surgery (BS) and Master of Surgery at the University of Sydney, and later his Fellowship from London’s Royal College of Surgeons and his studies in speech science at University of Keele in England, have prepared him for the level of specialised research the bionic ear would take.

Fundamental research was needed to find out if his vision could become reality, and it was conducted during Graeme’s PhD and his early years as the chair of the newly founded Department of Otolaryngology at the University of Melbourne. He confirmed that a multi-electrode implant capable of multi-channel stimulation was the better option, and studied how the brain reacted to the stimulation. His new position in the chair of Melbourne’s Otolaryngology Department gave him the opportunity to guide research in his field.
Yet with such a technologically advanced invention, the next biggest hurdle to overcome was funding. “The opportunity would be there to build on, and at least it was an avenue to get the work done, if money came. And therefore the problem was to get the money because it was going to take, early on, tens of thousands, and then hundreds of thousands to do the research that was needed,” says Graeme.

It was an uphill battle. The National Health and Medical Research Council gave no grants to Graeme and his team because those who reviewed the project did not think it was possible, and the $6,000 provided by the University of Melbourne was only enough to start up the project.

So Graeme had to go out and raise funds himself. “I started in a very modest way by talking at lunches. It was fortunate for me that Apex gave $2,000.”

Fortunately, a breakthrough came with Sir Reginald Ansett, then owner of Channel 0 (now Channel 10). “It was sufficiently interesting at the time for us to get onto the ABC news. And so Reginald Ansett who was just starting at Channel 0 at the time, used to watch the opposition news, and he saw this whole episode on the news. He needed a telethon and he thought, that was who I’d like to run a telethon for,” says Graeme.

Funds raised from the telethon proved to be vital. “It was for three years only, which gave us the money to actually buy the equipment and fund an engineer. I was the right person, at the right time. It was just then the silicon chip was discovered and the technology was becoming useful. This gave us, in 1974,  the capacity to develop a prototype implant we needed to put into a person to see if it was possible to break speech down in a way people could understand.”

The telethon money soon came to a stop. “Really, for the first time in the world, we could break speech down to signals that could be understood. Then the money stopped. We’d implanted patients; had all that exciting news, but then another headache,” recalls Graeme.

Not one to give up, Graeme went straight to the top for funds. “I went to the Prime Minister and I said, ‘I believe we’re ahead of other countries. I believe this is good for Australian industry and they took notice.” The federal government came to help with a public interest scheme, which gave money based on a yearly review of the progress Graeme’s project made. The scheme supported the bionic ear research up to the point when an industrial partner was found and Graeme and his team could take the prototype through to industrial development with the partner.

The reality

The commercial development of the bionic ear was especially difficult to kick-start. Australian scientific academia at the time was rather separated from the industry, unlike in the United States. “In America it’s good because you can actually transfer from industry back to university and not disadvantage your academic status. Whereas in Australia there has not been the same interaction between industry and academia taking place.”

Fortunately, with the help of the government scheme, Graeme and his team were able to find a partner in Cochlear Pty Ltd, and initially this was a subsidiary engineering team for the bionic ear created by Paul Trainor, owner of Teletronics. Teletronics were themselves Australian pioneers in producing artificial pacemakers, a device that stimulates and regulates heartbeats.
Marrying science with business is not an easy venture, and so the choice of Teletronics as the industrial partner was a careful, deliberate decision. Large communications companies such as Phillips had also expressed interest in the project at the time. “Fortunately, in some ways, I knew we really needed Teletronics rather than the others. Because the implant in a second patient failed, as we didn’t have great deal of expertise in sealing implant packages, which was where the pacemaker firm had made international progress.

“I knew how hostile the body was to the electronic device, and so it was a key decision in not having a large communications company. That decision would have proved to be wrong,” recalls Graeme.

The bionic ear took off relatively easily after Cochlear overcame expected technical difficulties. Graeme and his team implanted the first Cochlear bionic ear in six patients at The Royal Victorian Eye & Ear Hospital in 1982. This industrially-developed implant proved to be as successful as the previous implant produced by the University of Melbourne team.
The worldwide trial for the US Food and Drug Administration (FDA), held to determine whether it would be safe and effective did well, too, and in 1985 the approval came through. Since then, the bionic ear has been improved for implants in small children as well. It was the first bionic ear to be approved by a world regulatory body.
Looking back, Graeme admits amazement at how far his invention has come. “I didn’t know much. I didn’t know where it would go. I didn’t know whether I’d be out of a job. I didn’t know whether it would be successful. Nevertheless, I was determined to be a good scientist, and if necessary to prove ourselves wrong.

“Looking back as I do as I’m filing records, I’m staggered by the huge amount of work that I personally and the team has put in. Twenty-five years’ concentrated work, and it is that big. It didn’t seem a lot at first, but I had high energy levels, and it did eventually lead to a very large output. That was just amazing.”

What satisfies Graeme most in his 40 years work, is “the wonderful feeling to see, particularly young people, becoming friends. Some of them are almost part of the family. Young people, in many cases outsiders, would not know they have hearing problems. So the more one can continue, the more children benefit. And that’s satisfaction.”

The journey has been an impressive one, fuelled by passion, determination and the desire to do good. When asked if he saw himself as an entrepreneur, as well as a pioneer, he had this to say, “When you become a professor, you then realise you become not only a surgeon and a scientist, you also become a fundraiser, negotiator, politician and psychiatrist. And then when you take on a research team, you become even more, including an entrepreneur.

“You have to lead. If you don’t have ideas or basic directions, you cannot lead others to do business. It’s a very big ask to do all of those things.”