(Thanks to hohbob for head up to this article!)
NEWS from YESTERYEAR
First published in the New York Times, November 3, 1983
---
Technology
Steven J. Marcus
Implant in Ear Aids the Deaf
AT Kolff Medical Inc. of Salt Lake City, they call it the Ineraid artificial
ear. Biostim Inc. of Princeton, N.J., calls its device the Bioear. A joint
venture of the House Ear Institute in Los Angeles and the Minnesota Mining
and Manufacturing Company currently dominates the field with its House-3M
Cochlear Implant. And Nucleus Ltd., an Australian entry in the American
market, offers a Multichannel Cochlear Implant.
The four companies, combining advances in medicine and microelectronics, are
seeking to provide some hearing to people whose deafness is too profound to
be helped by ordinary hearing aids.
The work is based on a new technology that approximates sound signals with
electrical impulses delivered by devices implanted in the inner ear.
None of the four products is offered commercially; each is at some stage of
clinical evaluation under an ''investigational-device exemption'' granted by
the Food and Drug Administration. But approximately 450 implants have been
performed worldwide, and the results are encouraging enough to predict that
some deaf people may soon be able to regain some hearing.
For those who are nerve deaf, having suffered damage to the sensory hair
cells within the cochlea, or inner ear, that transmit sound to nerve endings
and the brain, a cochlear implant can in effect ''reconnect the cut wires,''
says Biostim's president, Lloyd A. Ferreira.
There are 300,000 people in the United States whom specialists consider
profoundly deaf; damage to their hair cells is so extensive that hearing
aids are useless. And it is estimated that about two-thirds of them could
benefit from implants. Two million others have suffered partial impairment
of the hair cells and cannot understand speech without a hearing aid, but it
is still too soon to say how many could do better with implants.
The devices, which resemble a Sony Walkman, cost about $5,000. But surgery,
hospital charges and therapy raise the total cost to about $15,000, and for
a relatively primitive system. People in the field expect that the size of
the device will become smaller, more sophisticated and more expensive, and
that its application could expand. ''I have absolutely no doubt,'' Mr.
Ferreira says, ''that the business will eventually achieve annual sales of
$1 billion or more.''
At the moment, says Pieter Halter, executive editor of Biomedical Business
International, a journal of the health-care industry, the market is
embryonic, with sales in the United States, for research purposes only, of
about $1 million. But he says this figure may exceed $40 million by 1988.
''There will be very rapid growth,'' he says, ''but probably not as rapid as
Lloyd predicts.''
Experts agree that House-3M was first into the field - its device has been
implanted in 380 patients - and could be approved promptly by the F.D.A.
once application is made. William F. House, president of the House Ear
Institute, estimates that it could be commercial within six to eight months.
But although such status would allow this implant to have the market to
itself for several years, 3M seems disinclined to rush.
''We are not in this for a quick killing,'' says Robert J. Oliveira, manager
of 3M's Otologic Products program. Greater understanding of the complex
hearing process must be gained before the benefits of a device - even a
relatively simple one like the House-3M implant - can be assessed. Thus 3M
is committed, Dr. Oliveira says, to long- term research that would spare
patients from unrealistic expectations and perhaps develop new areas of
technology for the company. ''To think in terms of a huge market right
now,'' he says, ''would weaken the effort.''
Another reason for delay could be the limits of the device itself. With a
single channel for electrical signals, the perceived sound ''sounds like a
radio that isn't quite tuned in,'' Dr. House says. And although it gives the
patient the ability to discern ''environmental sounds'' like footsteps or a
siren, and to hear voices, the patient cannot distinguish all the words.
Robert K. Jarvik, inventor of the Jarvik artificial heart and now president
of Kolff Medical, says patients have been satisfied so far with single-
channel cochlear implants simply because it took them ''from nothing to
something.'' These enable them to hear tones and improve their lip-reading,
he says, but only multiple-channel systems and other advances in
speech-processing electronics can provide something akin to real hearing.
Dr. House acknowledges that multichannel implants seem to advance the
technology. The Nucleus system, he says, ''is the most complex and
sophisticated system available.'' But he adds that ''more sophisticated
doesn't mean best,'' and that clinical trials have yet to show that the
approach will deliver on its promise.
Developers of the newer products aacknowledge that their confidence,
although not without basis, is premature; the Nucleus system has been
implanted in 12 patients and the Kolff in only 4. ''We bear reasonably good
news,'' Dr. Jarvik says, ''but we still have a long way to go.''
Yet if clinical trials prove successful, he adds, such products could be
''broadly available within two to three years.''
NEWS from YESTERYEAR
First published in the New York Times, November 3, 1983
---
Technology
Steven J. Marcus
Implant in Ear Aids the Deaf
AT Kolff Medical Inc. of Salt Lake City, they call it the Ineraid artificial
ear. Biostim Inc. of Princeton, N.J., calls its device the Bioear. A joint
venture of the House Ear Institute in Los Angeles and the Minnesota Mining
and Manufacturing Company currently dominates the field with its House-3M
Cochlear Implant. And Nucleus Ltd., an Australian entry in the American
market, offers a Multichannel Cochlear Implant.
The four companies, combining advances in medicine and microelectronics, are
seeking to provide some hearing to people whose deafness is too profound to
be helped by ordinary hearing aids.
The work is based on a new technology that approximates sound signals with
electrical impulses delivered by devices implanted in the inner ear.
None of the four products is offered commercially; each is at some stage of
clinical evaluation under an ''investigational-device exemption'' granted by
the Food and Drug Administration. But approximately 450 implants have been
performed worldwide, and the results are encouraging enough to predict that
some deaf people may soon be able to regain some hearing.
For those who are nerve deaf, having suffered damage to the sensory hair
cells within the cochlea, or inner ear, that transmit sound to nerve endings
and the brain, a cochlear implant can in effect ''reconnect the cut wires,''
says Biostim's president, Lloyd A. Ferreira.
There are 300,000 people in the United States whom specialists consider
profoundly deaf; damage to their hair cells is so extensive that hearing
aids are useless. And it is estimated that about two-thirds of them could
benefit from implants. Two million others have suffered partial impairment
of the hair cells and cannot understand speech without a hearing aid, but it
is still too soon to say how many could do better with implants.
The devices, which resemble a Sony Walkman, cost about $5,000. But surgery,
hospital charges and therapy raise the total cost to about $15,000, and for
a relatively primitive system. People in the field expect that the size of
the device will become smaller, more sophisticated and more expensive, and
that its application could expand. ''I have absolutely no doubt,'' Mr.
Ferreira says, ''that the business will eventually achieve annual sales of
$1 billion or more.''
At the moment, says Pieter Halter, executive editor of Biomedical Business
International, a journal of the health-care industry, the market is
embryonic, with sales in the United States, for research purposes only, of
about $1 million. But he says this figure may exceed $40 million by 1988.
''There will be very rapid growth,'' he says, ''but probably not as rapid as
Lloyd predicts.''
Experts agree that House-3M was first into the field - its device has been
implanted in 380 patients - and could be approved promptly by the F.D.A.
once application is made. William F. House, president of the House Ear
Institute, estimates that it could be commercial within six to eight months.
But although such status would allow this implant to have the market to
itself for several years, 3M seems disinclined to rush.
''We are not in this for a quick killing,'' says Robert J. Oliveira, manager
of 3M's Otologic Products program. Greater understanding of the complex
hearing process must be gained before the benefits of a device - even a
relatively simple one like the House-3M implant - can be assessed. Thus 3M
is committed, Dr. Oliveira says, to long- term research that would spare
patients from unrealistic expectations and perhaps develop new areas of
technology for the company. ''To think in terms of a huge market right
now,'' he says, ''would weaken the effort.''
Another reason for delay could be the limits of the device itself. With a
single channel for electrical signals, the perceived sound ''sounds like a
radio that isn't quite tuned in,'' Dr. House says. And although it gives the
patient the ability to discern ''environmental sounds'' like footsteps or a
siren, and to hear voices, the patient cannot distinguish all the words.
Robert K. Jarvik, inventor of the Jarvik artificial heart and now president
of Kolff Medical, says patients have been satisfied so far with single-
channel cochlear implants simply because it took them ''from nothing to
something.'' These enable them to hear tones and improve their lip-reading,
he says, but only multiple-channel systems and other advances in
speech-processing electronics can provide something akin to real hearing.
Dr. House acknowledges that multichannel implants seem to advance the
technology. The Nucleus system, he says, ''is the most complex and
sophisticated system available.'' But he adds that ''more sophisticated
doesn't mean best,'' and that clinical trials have yet to show that the
approach will deliver on its promise.
Developers of the newer products aacknowledge that their confidence,
although not without basis, is premature; the Nucleus system has been
implanted in 12 patients and the Kolff in only 4. ''We bear reasonably good
news,'' Dr. Jarvik says, ''but we still have a long way to go.''
Yet if clinical trials prove successful, he adds, such products could be
''broadly available within two to three years.''