5
Cochlear Implantation: Establishing Clinical Feasibility, 1957–1982

STUART S. BLUME

THE IDEA OF ELECTRICAL STIMULATION OF THE HUMAN EAR

Between the second half of the nineteenth century and World War II, a gap opened up between the scientific investigation of hearing on the one hand and the clinical (sub)specialty concerned with the ear—otology—on the other (Bordley and Brookhouser, 1979). For decades, the principal concern of otologists was with the (surgical) treatment of diseased tissue in and around the organ of hearing. Otologic surgeons developed many procedures designed to correct malfunctioning in the middle ear (fenestration, tympanoplasty) and in the vestibular system which provides the human with a sense of balance. Meanwhile, building on Helmholtz's classic studies, research on the nature and mechanisms of hearing was being conducted by physiologists, psychologists, and physicists. It was only rarely, and perhaps only in major centers of scholarship and research, that otologists were involved in this work.

In 1930, Wever and Bray, working in the Department of Experimental Psychology at Princeton University, discovered the so-called ''cochlear microphonic potential." They showed that if electrical contact was made with the auditory nerve of a cat and the potentials developed in it were amplified and passed through telephone receivers, sounds delivered to the animal's ear could be recognized by a listener. The quality of the "cat microphone" was such that if words were spoken into the cat's ear, a remote listener could identify them through the receiver. Although electrical phenomena were already known to be involved in the mechanism of hearing, this finding had major theoretical implications and it generated considerable interest (Davis, 1935). Various theories were put forward



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Sources of Medical Technology: Universities and Industry 5 Cochlear Implantation: Establishing Clinical Feasibility, 1957–1982 STUART S. BLUME THE IDEA OF ELECTRICAL STIMULATION OF THE HUMAN EAR Between the second half of the nineteenth century and World War II, a gap opened up between the scientific investigation of hearing on the one hand and the clinical (sub)specialty concerned with the ear—otology—on the other (Bordley and Brookhouser, 1979). For decades, the principal concern of otologists was with the (surgical) treatment of diseased tissue in and around the organ of hearing. Otologic surgeons developed many procedures designed to correct malfunctioning in the middle ear (fenestration, tympanoplasty) and in the vestibular system which provides the human with a sense of balance. Meanwhile, building on Helmholtz's classic studies, research on the nature and mechanisms of hearing was being conducted by physiologists, psychologists, and physicists. It was only rarely, and perhaps only in major centers of scholarship and research, that otologists were involved in this work. In 1930, Wever and Bray, working in the Department of Experimental Psychology at Princeton University, discovered the so-called ''cochlear microphonic potential." They showed that if electrical contact was made with the auditory nerve of a cat and the potentials developed in it were amplified and passed through telephone receivers, sounds delivered to the animal's ear could be recognized by a listener. The quality of the "cat microphone" was such that if words were spoken into the cat's ear, a remote listener could identify them through the receiver. Although electrical phenomena were already known to be involved in the mechanism of hearing, this finding had major theoretical implications and it generated considerable interest (Davis, 1935). Various theories were put forward

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Sources of Medical Technology: Universities and Industry about how exactly mechanical vibrations (sound waves) are turned into electrical stimuli carried by the auditory nerve to the brain. The inner ear, or cochlea, functioned as a transducer. But how, exactly? And what components of its complex structure were involved? Most of this research was conducted on experimental animals: cats and guinea pigs. Gradually, in the course of the 1930s and 1940s, connections between this work and another well-known but curious fact began to be made. In 1800, Alessandro Volta had passed an electrical current through his head by placing an electrode, connected to a battery, in each ear. Completing the circuit led to a disagreeable sensation and a noise said to have been like the boiling of thick soup. Some subsequent experiments failed to replicate Volta's finding. In the 1930s, a number of workers were investigating this phenomenon, that is, the generation of acoustic effects by electrical stimulation of the ear. A particularly active group was at Harvard University: S. S. Stevens (Psychology Laboratory), H. Davis (Department of Physiology, Harvard Medical School), and M. H. Lurie (Department of Otology, Harvard Medical School). A series of experiments was carried out, along the following lines. Electrical circuits were made in which one electrode was a copper wire inserted into a saline-filled ear, while the ground electrode was attached to the arm. Various AC and DC currents were used. Depending upon characteristics of the circuit and the ear, various acoustic sensations could be induced in an experimental subject: a pure tone corresponding to the frequency of an alternating current; a "buzzing" noise independent of frequency; both tone and noise; or (in some listeners) nothing at all. Tones tended to be distorted. Stevens demonstrated this by connecting the electrodes of the subject to the output circuit of a radio: Music can be heard and popular tunes identified, but the quality is definitely poor—"tin pan" music. Speech can easily be recognized as speech, but only occasional words can be understood. Clearly, electrical stimulation does not promise much as an alternative means of hearing so long as so much distortion is present (Stevens, 1937). In 1940, it was hypothesized that this electrophonic phenomenon takes place by three distinctive mechanisms (Jones et al., 1940). One of these mechanisms, the one generating the pure tone, was believed to be related to the cochlear microphonic, in which a vibration was thought to be set up in an intracochlear membrane. The noise phenomenon was believed to be due to direct stimulation of the auditory nerve, a result also obtained by workers in the Soviet Union (Andreef et al., 1935). A "threshold effect" was also noted. Small differences in voltage separated an acoustic sensation from the experience of pain. Moreover, because the auditory nerve is also involved in the sense of balance, and also lies very close to the facial nerve, dizziness or facial twitches could also ensue. With the emergence of modern audiology, concerned with the clinical assessment of hearing in the 1940s and 1950s, and the subsequent development of sophisticated audiometric devices, the focus of general otological practice began

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Sources of Medical Technology: Universities and Industry to change. Through an emergent partnership with audiology (which in many European countries—in contrast to America and Britain—emerged as a specialization within medical otology) otologists were beginning to develop a new interest in hearing. Many of their older preoccupations, like lupus, were of declining significance, thanks to new antibiotics (Jongkees, 1982). Nevertheless, in the 1950s and 1960s interventions were still limited to addressing (typically mechanical) deficiencies of the middle ear. Problems of the inner ear, associated with so-called sensorineural deafness, remained intractable. There was nothing in current practice, either surgical intervention or in the acoustic amplification provided by a conventional hearing aid, that offered hearing to the sensorineurally deaf. This was so despite continuing work in neurophysiology and psychophysics, which was adding to understanding of basic mechanisms. In February 1957, a totally deaf person about to be operated on begged Paris otologist C. Eyries to try to give him some minimal hearing. Eyries approached A. Djourno, who was working on electrical stimulation of the auditory nerve in animals. After some deliberation they decided to try to implant the patient with an electrode, similar to that used in the animal research, which would stimulate his (functioning) auditory nerve. The electrode was constructed in the physics laboratory of the University of Paris Faculty of Medicine, and on February 25, 1957, this device was implanted. Various tests were done, but in March the device broke down. It was repaired and replanted, and in July rehabilitation was started with a speech therapist. Very rapidly the patient's initial enthusiasm faded, as his expectations failed to be borne out. It soon became apparent to the patient that different kinds of sounds could not be distinguished: speech, opening a door, dragging a chair—all sounded the same. In March 1958, the patient decided that he wanted to terminate the rehabilitation. Nevertheless, despite the bulk of the device and despite the difficulties in distinguishing frequencies (which suggested to them that more than one electrode would be needed), Eyries and Djourno felt that the technique had a future. The three cases they implanted between February 1957 and November 1958 gave cause for optimism, they felt (Albinhac, 1978; Djourno and Eyries, 1957). A Los Angeles otologist, William House, was one of those inspired by a report of this work. Then of the Ear Research Institute in Los Angeles, "an ordinary ear doctor," he was intrigued by what Djourno and Eyries had tried to achieve: I remember that a patient brought me a little clipping from a newspaper about this particular work and about the results on the patient. That was in my first year of practice, which was 1956. I was very stimulated by that. I thought it was amazing that this might be done. I went ahead and got the article and had it translated because I don't read French very well. The amazing thing to me is that Djourno and Eyries never published any more on it, nor did they do more than, I think, two patients. That stimulated a lot of interest on my part. I remember getting some oscillators and electrodes together and during the stapes

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Sources of Medical Technology: Universities and Industry and chronic ear surgery we were doing at that time … we had a lot of opportunities to put electrodes on the promontory during surgery and ask the patients what they heard. It was really an eye opener what they could hear from these electrical stimulations during surgery. This encouraged us then to pick out some patients who had total losses as volunteers, and take them to surgery and try some of these stimulations … (House, 1985). In 1961, House implanted an electrode, constructed by a collaborating engineer, into the cochlea (more precisely, the scala tympani) of a man deaf from advanced otosclerosis. House's implant was different from that used in Paris. It was designed so as to stimulate the cochlea at five different positions along its length. The electrode was soon rejected. The wires were insulated with silicone rubber which at that time contained some toxic substances. The implanted patient began to develop symptoms that led Dr. House to explant the electrode after about three weeks. In addition, recalls House, we were also beset by other problems. We began to be deluged by calls from people who had heard about the implant and its possibilities. The engineer who had constructed the implant exercised bad judgment and encouraged newspaper articles about the research we were doing. We brought the first phase of our active investigation to a halt (House and Urban, 1973). In fact, the engineer who had been working with Dr. House formed a company intended to sell stock in what was later to become the House implant. It is noteworthy that, although Dr. House dissolved the partnership, the engineer in question was able to continue work on the subject with another group in Los Angeles. They published what was probably the very first U.S. paper on the subject in 1963 (Doyle et al., 1963). Although convinced of the potential of the technique, Dr. House suspended active work on cochlear implantation at this point. Blair Simmons, professor in the department of otolaryngology at Stanford Medical School, came to cochlear implantation with a quite different set of interests and resources. Simmons had a long-standing scientific interest in physiological processes of sound and pitch reception. In the 1950s, he had been involved in experimental work involving placing electrodes in the entrance to the cochlea (the so-called "round window") using cats. Like Eyries and Djourno earlier, Simmons was presented with the opportunity to attempt something on a human (who had nothing to lose) which he had previously (only) tried on experimental animals. Simmons carried out his first experiment with a patient who had had a right cerebelectomy in 1962 (Simmons et al., 1964). Part of the rationale was to see if the patient could adequately distinguish pitch on the basis of differences in the rate of stimulation. Then-current theory suggested that so-called "rate encoding" should be possible, but only to a small extent. He subsequently wrote of this work:

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Sources of Medical Technology: Universities and Industry We had the unexpected opportunity to stimulate the auditory nerve under direct vision in a patient who had previously had a right cerebelectomy. It seemed like an interesting thing to do even though nearly everyone who was an authority on hearing was then firmly convinced that Wever's and other earlier volley theories were totally wrong. It was thought that if the rate pitch did exist it was limited to no more than 200 Hz—the buzz and cricket sounds described by Djourno and Eyries in 1957, and by others in the 1930s (Simmons, 1985). It appeared from first observations that this patient perceived much more than would theoretically have been expected: It seemed reasonable to repeat these stimulations with better controls. By this time my animal work with electrodes had long since left the round window in favor of recording via permanent electrodes in the scala tympani and the modiolus. While insertion of these electrodes did produce serious tissue damage in about one-half of the animals, many were without damage. … It seemed reasonable to use these same methods with a human volunteer (Simmons, 1985). Simmons was also provoked, he says, by the 1963 publication, which had made him very angry with its (in his view) "irresponsible claims" that the deaf could be made to hear (interview with F. B. Simmons, Stanford University, April 20, 1992). In May 1964, Simmons and a Stanford colleague implanted a 6-electrode array into the modiolus of a 60-year-old volunteer subject who was totally deaf in the right ear and was losing his hearing in the left ear. Suffering from retinitis pigmentosa, the subject was also losing his sight. "We were amazingly lucky," Blair Simmons commented later. "All electrodes functioned and remained so until he was explanted 18 months later" (Simmons, 1985). The subject could identify sound as speech by recognizing low sound frequencies, the time patterns, and some variation in loudness, but he could not identify individual words or phrases. The paper in which Simmons (1965) reported this work, published in Science, recounts a series of experiments done with this subject. Many of these experiments concern the subject's ability to discriminate stimuli that differed either in the location of the electrode stimulated (''place encoding") or in the number of pulses per second provided ("rate encoding"). The participation of the subject in this research is itself worthy of note: he is presented as a virtual co-worker (see Simmons et al., 1965).1 The named co-workers, however, are not from California but from Bell Telephone Laboratories in New Jersey. Simmons had been unable to find local experts in auditory psychophysics willing to work with him in confirming the kinds of results he was getting with his 60-year old subject. It so happened that one of his graduate 1   The subject appears in the paper as literally contributing through his own informed judgment ("The comparison with a bee buzz offered by the subject seemed particularly informative"; "judging from the subject's description of the sounds …"). This corresponds with Fox's account of clinician-subject relations in transplant programs (see Fox and Swazey, 1974).

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Sources of Medical Technology: Universities and Industry students knew people at the Bell lab in Orange, New Jersey. They were very interested in doing the verification, provided Simmons was willing to assume full responsibility for the patient. "They were outsiders. I don't think they'd read the publicity" (interview with F. B. Simmons, Stanford University, April 20, 1992). Legal liability for the patient was also something: neither Bell nor Stanford University was willing to accept it. Simmons and his wife traveled with the patient who, 60 and nearly blind, was making his first trip by plane. At the Bell labs they got the same results, and this resulted in the Science paper of 1965. The scientific and medical communities were not persuaded by the results that Simmons obtained. The American Otological Society rejected presentation of this work at their 1965 meeting, while an application for funding to the National Institutes of Health (NIH) was turned down. Blair Simmons then stopped working on human auditory stimulation, though continuing with related experimental work on cats. By the 1960s, many investigators had produced acoustic sensations by means of electrical stimulation of the inner ear, in the context of research into the nature of hearing. Whatever the long-term objectives or expectations of these studies might have been, no one previously had sought to carry out such work in a clinical context. The clinical context had previously been, as it were, latent. We can see traces of it in, for example, Stevens' observation (quoted above) that in the present state of things "electrical stimulation does not promise much as an alternative means of hearing" (Stevens, 1937). It could, however, be invoked where the constraints of scientific argumentation were removed, for example, in newspaper accounts. The slightest suggestion of "making the deaf hear" was enough. M.H. Lurie, in a 1973 discussion, refers to the work that he and others had carried out in the 1930s: I remember when Dr. Davis and I gave the first demonstration at the international meeting of the Physiologists. The newspapers obtained a report of the presentation. The first thing I knew I received letters from individuals all over the world asking when could they come and have their hearing restored and that is the great danger of … this work appearing in the newspapers and the ensuing publicity. … There will be people demanding that these procedures be done on them … (Lurie, 1973). Eyries and Djourno, House, and Simmons had now made the clinical context of electrical stimulation manifest. However, it is clear that at that time artificial stimulation within a clinical context could not be sustained. House, Eyries, and Simmons each stopped work after two or three attempts, discouraged by the recalcitrance of both the communities and the materials with which they had to work. Neither technology nor professional communities could support their ambitions. Within a few years, however, both House and Simmons were drawn back to the idea of the clinical application of electrical stimulation to humans. What led them to start again?

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Sources of Medical Technology: Universities and Industry House, who started again in 1968, refers to technical developments: in materials technology resulting from the development of heart pacemakers, as well as in electronics (the transistor). Blair Simmons, who resumed work in 1971, explains the developments that led him to do so not in terms of advances in available technology, but in terms of the willingness of technologists (and physiologists) to collaborate with him. In the 1960s, there had been problems he had not been able to overcome: Gaining credibility or even cooperation from scientific colleagues in 1964 was not easy, particularly in California. The basic scientists were openly hostile towards anything having to do with cochlear implants, largely because there were extravagant claims for implants being made, both at clinical meetings and in the newspapers. Speech was said to be understood. Some patients could even converse over the telephone. There were testimonials about hearing the chirping of mockingbirds once again, enjoying symphony music, etc. While my 1964–1965 experiments were in progress I contacted at least six of the most prominent researchers in speech coding and others in auditory psychophysics. None of these persons were willing or interested in suggesting experiments which might have helped define speech coding strategies for the future. I got a distinct impression, perhaps colored by a little personal paranoia after the first few rejections, that everyone was either incapable of thinking about the many problems involved or would rather not risk tainting their scientific careers … (Simmons, 1985). In the course of time, he recounts, he "learned the hard way that this type of experimentation needs a team.… It was and is easy to place electrodes in ears. The hard part is deciding upon coding schemes and the hardware and software to stimulate these electrodes" (Simmons, 1985). In contrast to the situation in the early sixties, work in the seventies could be sustained. Not only House and Simmons, but San Francisco colleague Robin Michelson, followed by otologists across the United States, Europe (Austria, Britain, France, Germany, and Switzerland), and Australia, involved themselves in cochlear implantation. By about 1980, their efforts had led to the stabilization of a clinical context for this work. Otologists were beginning to accept that cochlear implantation had a place in professional practice, and industry was beginning to manifest some interest. The stage was being set for a complex debate, in which, for some, cochlear implantation would come to "stand for" a medical understanding of deafness which they increasingly rejected. Ethical, social scientific, educational, and economic arguments, interests, and perspectives became inextricably interwoven in a bitter debate, which still continues. In this paper the perspective is more limited. The empirical focus here is on some of the programs of work on implantation that flourished in the 1970s. Analytically, we shall try to understand how these workers, collectively, sought to establish the clinical context within which cochlear implantation could eventually become an acceptable medical treatment for sensorineural deafness. As we look at these programs

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Sources of Medical Technology: Universities and Industry of work we shall see that they differ in fundamental respects from one another. Another question to be addressed then, will be why and how they differ. By the way of reaching answers to these questions, we will first make some general observations about how approaches to implementation may differ and then review in some detail the new beginnings made in cochlear implantation during the 1970s. We shall then be in a position to characterize how the process of establishing clinical feasibility unfolded and, finally, draw conclusions. APPROACHES TO IMPLANTATION The argument developed in Insight and Industry is that the "career" of a new medical technology is highly dependent on whether it emerges within or outside an existing "inter-organizational field" (Blume, 1992). That is, when the "vision" of a new technology emerges within an existing field of relationships between professionals and their supplying industry, it is sustained by existing structures. Work on the new modality can be published in established journals, attracts an established audience, and can be assessed on the basis of agreed criteria of utility and according to established research protocols. By contrast, a conception emerging outside such a field faces quite different sorts of problems. For whom is it of interest? How is its value to be assessed? How can the expertise necessary for its further elaboration be assembled? In these terms, and given the lack of prior clinical approaches to sensorineural deafness, we would expect the development of cochlear implantation to pose major problems of assembling the necessary human resources. And so it seems to have been. Pioneers in the field who may have agreed about little else nevertheless agree that it was an uphill battle. They faced considerable direct opposition in the early years, particularly from within the scientific community. Far more was—and is—needed than the skills of the surgeon. At the very least, a program of cochlear implantation requires a device (so that both electrodes and speech processors have to be developed and built, a task for electronics experts); it requires subjects (who of necessity have to believe that the uncertain benefits of an experimental procedure are worth the physical and emotional costs); and it requires a means of teaching implantees to make sense of the unfamiliar acoustic sensations which they receive (which may require the skills of a speech therapist). The essentially interdisciplinary nature of cochlear implant development reflects the problems of assembling these, and perhaps other, skills and integrating their contributions. A review of work on the emerging technique published in 1978 draws attention to the range of problems which cochlear implantation still posed: Artificial stimulation of the auditory system therefore poses difficult problems for the surgeon, the engineer, the physiologist, the speech therapist, the audiologist and the pathologist. How to achieve adequate selectivity of neural activation with minimal surgical invasion; how to devise biocompatible and reliable

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Sources of Medical Technology: Universities and Industry electrodes and transmission systems and adequate spatio-temporal patterns of excitation; how optimally to encode the stimuli and yet prevent further damage to the nervous system; how to exploit what auditory clues are afforded the patient; how to assess the number and distribution of surrounding neurons—these are some of the unanswered questions (Ballantyne et al., 1978). The fact is, however, that few groups sought to confront all these issues. Their strategies differed. For example, whereas Simmons and his Stanford colleagues made the electronics of the device a major focus for continuing research, House preferred to have development work done elsewhere (thus rapidly involving industrial contractors). Whereas some groups conducted prolonged experiments in auditory physiology (using both animals and patients), other groups had neither facilities for nor belief in the need for animal work. Because, as we shall see, the various groups differed so considerably in their research and development strategies, one cannot readily characterize the interdisciplinary nature of the development process. Different strategies entailed the recruitment and coordination of different combinations of expertise. NEW BEGINNINGS: COCHLEAR IMPLANTATION IN THE 1970s Work by House, Simmons, and Michelson In 1968, William House turned back to cochlear implants, working now with Jack Urban, the president of a small engineering firm with interests in medical electronics. In 1969 and 1970, three patients were implanted with 5-channel arrays into the cochlea introduced via the round window. Signals and power were transmitted via a transcutaneous button (a kind of small plug set into the skin behind the ear). The button was rejected in one patient at an early stage, and explantation was necessary. A second patient, deaf from advanced syphilis, moved away and work with him had to be suspended. Substantial work was done with the third patient. Despite the fact that the basial turn of cochlea only was utilized and despite the unipolar stimulation, there was evidence of pitch discrimination based on both the "place" and the "rate" of the stimulation. The work was presented at an American Otological Society conference in April 1973, and subsequently became House's first substantial publication on the subject (House and Urban, 1973). The paper discusses the various "speech coding strategies" (e.g., alternative means of presenting speech or the essentials of speech electronically) that were tried. It was after some 18 months of work on alternative strategies (which meant, in essence, different circuits and so different devices) that the patient himself chose the one he himself preferred. This turned out to be a relatively simple circuit which could be miniaturized and, for the first time, turned into a wearable aid. In mid-1972, the patient was allowed to take his

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Sources of Medical Technology: Universities and Industry aid home. Much of the 1973 paper is devoted to a letter from this patient describing his experiences, his progress, and his expectations. At about this time the House group changed their strategy dramatically, and decided to concentrate their efforts on a single-channel electrode. Implantation with this began in 1972. House and his colleagues were convinced that in the current state of development multichannel implants offered no significant advantages over single-channel implants, and were very much more difficult to construct. In the five years following their switch to single-channel systems, the House group devoted a good deal of their energies to perfecting the rehabilitation offered implantees, with the objective of exploiting the limited possibilities of single-channel stimulation to the full. By October 1977, by which time 22 patients had been implanted, they had developed an extremely well-equipped otological and audiological center staffed by an otologist, audiologist, speech therapist, and psychologist. Constructing the implants, which was done outside, cost about $800. A group of British visitors was told that total patient cost was about $8,000, but this was totally funded from the private sector and no charge was made to the patient (Ballantyne et al., 1978). While William House was moving towards a clinical procedure, Blair Simmons' approach was very different. When Stanford colleagues in electrical engineering became interested, in about 1970, the cochlear prosthesis program was reestablished. Simmons and electrical engineer Robert White applied to NIH for support for development work on a cochlear implant. Simmons' work, unlike House's, was thus subject to formal assessment by biomedical researchers and clinicians. Major doubts remained, some taking the view that the implant would necessarily damage the ear and that the benefits had not been shown to outweigh the risks. The application proved controversial. Nevertheless, in 1971 a grant was received.2 Quite differently from the House group, Simmons and White devoted the first years of their new investigation exclusively to developing the best possible multichannel implant, on the basis of a program of research in neurophysiology (animal experimentation) and electronics. Collaboration between otologists and electronic engineers did not prove easy. In part, according to Blair Simmons, this was because of differences in motivation. The clinicians' interest was in developing a useful device whereas he sees that of the electronic engineers as having been more in the research process: a useful source of Ph.D. projects. Every time 2   Though not without difficulty. The proposal led to a site visit from a group of NIH peer reviewers, unusual (according to Simmons) for such a project. The proposal was in fact rejected by the relevant NIH study section ("on moral grounds," says Simmons, "[whereas] they're supposed to make the decision on scientific grounds"). Ultimately, however, the advice of the study section was not taken, and NIH decided to award the grant (interview with F. B. Simmons, Stanford University, April 20, 1992).

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Sources of Medical Technology: Universities and Industry a talented graduate student completed his or her Ph.D. their expertise was lost and a new start with a new researcher had to be made (interview with B. Simmons, Stanford University, April 20, 1992). When British observers John Ballantyne, Edward Evans, and Andrew Morrison visited Standford in October 1977, only two (volunteer) patients had been implanted (in September), with a newly developed 4-electrode device; the objective was to "optimize stimulation strategies," although it was intended that the subjects "be provided with wearable control units in the future" (Ballantyne et al., 1978). At the time of this visit, Blair Simmons continued to regard cochlear implantation as an experimental procedure, and took the view that widespread clinical prescription of single-channel devices was premature. "All implants have been multichannel, made directly into the body of the cochlear nerve through the modiolus, in the belief that, with direct contact between electrodes and nerve fibers, thresholds would be lower, excitation would be more discrete and there would be less chance in principle of electrodes encountering 'gaps' in the array of surviving fibers than in the cochlea" (Ballantyne et al., 1978). Development work was continuing on a number of fronts. One priority was replacement of the transcutaneous button transmission system by a much more sophisticated system then undergoing tests. The British visitors were impressed by the electronic link system being developed. "This employs two separate transmission systems: an ultrasonic link transmitting pulse-coded information on when each of the four channels is active, their pulse duration, phase and amplitude; and a radio frequency link providing the power for the implanted package'' (Ballantyne et al., 1978). Various aspects of the "take home" package with which patients should be supplied were still under discussion. On the basis of results from the first two patients plus one awaiting implantation it was hoped to develop "a coding system which will establish transfer of information on, say, the amplitude envelope of the acoustic signals and on the speech fundamental (laryngeal) frequencies. There is still discussion within the team about the optimal strategy which should be employed both for the psychophysical testing and for the short-and long-term attempts at coding speech signals" (Ballantyne et al., 1978). The intention was still to keep the program small, to try to get the optimum information from small numbers of experimental subjects ("healthy English-speaking adults between 21 and 65 years of age, with total post-lingual deafness … adequately motivated and still functioning in society") (Ballantyne et al., 1978). By this time Dr. Robin Michelson, an ear surgeon at the University of California, San Francisco (UCSF), who had previously worked at Stanford, had also started work. Michelson was a man of unusual background, having been trained originally as a physicist. He had also done some cat studies (which had led him to a number of theoretical conclusions that informed his subsequent clinical

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Sources of Medical Technology: Universities and Industry He had succeeded in making a significant contribution to what was becoming an area of considerable interest in the specialty. The idea that he work on artificial stimulation came from outside. The British department of health, prompted by a deafened Member of Parliament active on behalf of the disabled (Jack Ashley, now Lord Ashley), suggested to him that his specialty was doing far too little on sensorineural deafness, and why didn't he do something in that area. It was suggested that he apply to the Medical Research Council (MRC) for research support. Douek decided that, before going off to the United States and seeing what House and the others were doing, he'd try it himself. This he did, sticking an electrode to the outside of a patient's cochlea. Surprised by the results—which seemed to show that you could get the same kind of results House was getting with an implanted electrode merely by attaching an electrode to the round window—Douek went off to the MRC. Some discussion of artificial stimulation was already taking place in the MRC's Subcommittee on Sensorineural Deafness. The MRC's basic scientists were not impressed by his rudimentary experiment. Like their colleagues at NIH in Washington, MRC scientists were skeptical of the value of the approach: real language was far too complex. At this point the MRC put Douek in touch with London University phoneticist A. Fourcin: We went to his department, which was like a magic cavern for me, with equipment that I'd never seen, and so on. He had an apparatus, which he had invented, called a Laryngograph. He said, "Look, if we put these electrodes on someone's neck it will record the changes in the pitch of the voice. Not speech. Speech is the mouth." … I'd thought of speech and voice as one thing.… He said to me "Look at this." And there was an analysis of all the voice recordings with the Laryngograph. He said "What does that remind you of? Isn't it exactly the same pictures that you were able to produce by electrical stimulation?" (interview with E. Douek, London, May 1992). Fourcin demonstrated to Douek how an acoustic stimulus based on voice frequencies added to the information which could be read off from the lips. In late 1974, the MRC set up a small working group, based in a leading institute of acoustic research (the Institute of Sound and Vibration Research at Southampton University). The working group had the task of assessing existing research in the area of artificial auditory stimulation, and of recommending research to be carried out. Both Douek and Fourcin were members of this group. The working group concluded that while artificial stimulation was potentially useful "to the small number of patients who become totally deaf through a cochlear degenerative disorder," its practical achievements to date were limited (Thornton, 1977). A simple approach was recommended, involving placing a single electrode on the round window. Avoiding the risks of implantation, and the complex electronics of other approaches, work along these lines should yield a variety of information on pathology, physiology, psychoacoustics, and surgical techniques. The working group's recommendations, presented in 1976, were

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Sources of Medical Technology: Universities and Industry accepted by the MRC. Douek and Fourcin, together with Cambridge psychologist Moore, presented a research proposal along the lines of the working group's report, which was also accepted. In January 1977, the project, in which the Hearing Research Group at Guys Hospital (including the surgeon Douek, a medical physicist, and an audiologist), the Department of Phonetics at University College (University of London), and the Department of Experimental Psychology at Cambridge University all collaborated, started. First results were published in the course of 1977. The project differed from others in two important respects, which were repeatedly stressed. First, deriving from Douek's initial experiment, was the view that a less invasive extracochlear approach should be used. The minimally invasive strategy was based on a quite different assessment of the risks of implantation: of infection; of irreversible damage to the cochlea; of corrosion of the electrode by cochlear fluid; of uncontrolled bone growth inside the cochlea. Intracochlear implantation would confront the surgeon with a dilemma, and might tempt him to jeopardize his patient's best interests: The risks associated with intra-cochlear intervention require that patients should have no useful hearing in either ear—this is a "nothing to lose" situation as it would be unreasonable to place a permanent implant in the ear of a patient who has some useful hearing in the other. Yet from the point of view of progress in this field few cases could be more useful, both to match sound perceived with electrical stimulation and to compare, say, the value of such stimulation with amplification in the other ear (Fourcin et al., 1979). Second was Fourcin's important contribution: the idea that, at least at first, the implant should be used to supplement the information available from lip reading. The attempt to provide "hearing" was not a realistic goal, at least not at first. Our initial program of work was based on the expectation that the post-lingually totally deaf adult would depend on lip reading for speech communication, and be able to make use of any speech-relevant sensation by reference to an earlier memory of speech patterns (Fourcin et al., 1979). The implication of this view was that the acoustic input to the implant should be not the whole speech signal, but rather those elements not available to the deaf lip reader (in effect, the fundamental frequency alone). The unique composition of this team was reflected in its approach to assessing the utility of the implant. Psychoacoustic tests concerned the perceptions associated with different kinds of stimulating waveforms, as well as the discriminations potentially useful in speech communication situations. Speech perception tests included investigation of the ability to discriminate questions and statements on the basis of intonation, to locate stress in a spoken sentence, and so on. These tests, in effect, are based on a detailed understanding of the limitations of lip reading. Like Simmons, the London-Cambridge group had no intention of

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Sources of Medical Technology: Universities and Industry implanting large numbers or of offering a clinical service. They saw themselves (and indeed continue to see themselves) as a research team. Threshold of a New Era By the end of the 1970s, cochlear implantation was becoming a respectable topic of discussion. Gradually, it was acquiring a degree of credibility in professional otological circles. The results of an independent assessment of House implantees, which showed modest but definite benefit (Bilger et al., 1977), contributed significantly in this respect. Also in 1977, the British department of health invited a group of three experts (two ear surgeons and a neurophysiologist) to review current efforts in the area of electrical stimulation of the inner ear and to make recommendations as to what British commitment to the area should be. In October 1977, these experts visited all active U.S. centers including, as already mentioned, the House group and the Stanford group. Their report (Ballantyne et al., 1978) is in fact critical of the overall effort in a number of respects,11 while nevertheless accepting the promise of the technique. Viewing full-scale clinical provision as premature, Ballantyne, Evans, and Morrison in 1978 thus recommended a cautious approach in Britain, starting with a careful evaluation of the single-channel implant. In the period 1978–1982, however, industrial corporations were beginning to become interested. A recent analysis of the growth of industrial involvement in cochlear implants speaks of "a period of trial and negotiations between 1978 to 1982 as firms and academicians attempted to enter into licensing agreements" (Garud and van de Ven, 1989). These beginnings of an "inter-organizational field" were not easy, and a number of attempted collaborations soon foundered.12 There is no doubt, however, that by 1982 a new era in the history of cochlear implantation had begun. Ballantyne, Evans, and Morrison bear witness to this. In 1982, these British experts published an update of their earlier report 11   "There seems to have been inadequate appreciation and application of the basic physiological and psychophysical information already available, on the processing of speech sounds at peripheral levels of the auditory system, by many of those controlling the implant programs. This has meant that the expected information-carrying capabilities of single-channel stimulation (e.g., prosodic and voicing cues) have been but little exploited … It is surprising and extremely disappointing to note that unequivocal quantitative data on the benefits of cochlear implantation [compared to high-powered hearing aids and vibrotactile aids] are as yet not available …". 12   Thus in 1977 3M was approached by Graeme Clark's group at the University of Melbourne, which was interested in commercializing its cochlear implant technology. This proved abortive and Clark, with major support from the Australian government, turned elsewhere. Between 1978 and 1982 3M worked with Michelson at the University of California, San Francisco. A UCSF-3M device was developed and implanted into two or three individuals in 1980–1981. When this agreement was terminated in 1982, UCSF went elsewhere, while (in 1981) 3M entered into licensing agreements with both House and a group at the University of Vienna.

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Sources of Medical Technology: Universities and Industry (Ballantyne et al., 1982). In it, they argue that progress in the intervening period has been such as to lead them to revise their earlier emphasis on caution. Despite continuing uncertainty as to the relative utility of single-channel and multichannel implants, the value of the technique has been proven. Ballantyne and colleagues recommended that the United Kingdom establish a limited number of implant centers forthwith, concentrating on patients with whom success is to be expected, and working according to a common protocol. THE "CLINICIANS," THE "EXPERIMENTALISTS," AND THE ESTABLISHING OF CLINICAL FEASIBILITY Among those otologists working on cochlear implantation William House is generally acknowledged as the "founding father." His place of honor at international conferences and the frequent demand for his recollections of the "early years" are witness to his status among his colleagues. Why should this be, given the previous history of work on electrophonic effects, and given the enormous criticism which his work received? The answer has to be sought in House's contribution to the stabilization of a clinical context for work on electrical stimulation. It was House's work, more than that of Simmons or Michelson and Merzenich, that attracted the attention of European otologists. It was House, and then in the same sort of way Chouard in France, who tried rapidly to establish a means of providing "the deaf" with an auditory prosthesis. The strategy adopted had a number of elements. First, the claims of basic scientists that "it would not work given current knowledge" had to be countered. This was done by showing that it simply did, by "letting the patients speak." Patients were "made to speak" in various ways. One way, traditional in pathological approaches to the deaf, was simply to present live patients to an audience. A successful performance by a oralized individual is a traditional form of persuasion. Ballantyne et al. (1978) visiting House's institute, describe such a performance: Five implanted subjects were demonstrated to an audience which, in addition to ourselves, included visitors from Germany and the United States. They came in one at a time and sat on a platform, where they were interviewed by … a teacher of the deaf who is Director of Rehabilitation at the Center. Similarly, Chouard wrote of his patients "performing" on television, while House devoted a large part of his first major article on implantation to the "testimony" of a patient. The latter's account of his successful social functioning bore witness to what had been—and thus could be—achieved. For a lay public, and indeed for many clinicians, such performances are far more convincing than any statistical analysis of word-recognition tests. Moreover, such individual experiences—with their references to the rediscovered delights of music or bird song—are

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Sources of Medical Technology: Universities and Industry far more newsworthy than are dry statistics and complex batteries of audiological tests. Second, the claims of medical colleagues that, given limited knowledge both of benefits and of possible damage, this kind of "human experimentation" was wrong had also to be countered. This could be done by arguing that it was not correct to view what was being done as "experimentation." Under attack by Kiang in 1973, as discussed earlier, House used this argument: I am trying to do everything I can to improve the patient's situation. That is basically different from an animal experiment in which I am required for scientific reasons to sacrifice the life of the animal. … If I put an electrode in a patient's ear, will it cause some serious harm to the patient? If not, and if there is some chance of benefiting the patient, is whatever the risk that is involved worthwhile? … I, therefore, think that this whole matter of human experimentation is not applicable in this case because we are doing everything we can for the welfare of these patients … (House, 1973). Insofar as circumstances and resources permitted, both House and Chouard tried as nearly as possible actually to offer a clinical service from the mid-1970s. That implied considerable attention to patient recruitment (of as large numbers as possible, but also to characteristics likely to lead to success) and to rehabilitation (both House and Chouard took great pains to establish an effective rehabilitative regime, involving speech therapists, audiologists, and so on) as quickly as possible. It was these colleagues whose job it ultimately was to "make the patients speak." It also implied attention at an early stage to the problem of fabricating adequate prostheses at reasonable cost. House chose to start implanting single-channel devices in 1972 because (he argued) there was no reason to suppose that they were inferior and because they could be fabricated much more easily at very much less cost. Chouard very rapidly sought an industrial partner (Bertin), which began to produce prostheses for his use in 1975, and was ultimately able to scale up production. It is reasonable to interpret these efforts at creating a stable clinical context in which work on implantation could be pursued in terms of notions of "mobilization" or "enrollment"—of colleague otologists and audiologists, willing to refer possible implant candidates; of industry viewing an interesting potential market; and of health authorities willing to bear the costs of providing prostheses to selected patients. Successes and failures in this respect are highly dependent on national contingencies and political alignments. For example, Chouard began to implant children at a time when professional consensus ruled this out in other countries. Whatever the moral or scientific arguments for and against his views, it did mean that Chouard extended the kind of service he sought to provide. On the other hand, it was this decision which, by antagonizing the powerful parents' organization ANPEDA, evoked a critical response from the previously silent profession.

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Sources of Medical Technology: Universities and Industry Most important of all, deaf or deafened individuals had to come to conceive of themselves in relation to the new technology. The category of "potential implant candidate" had to be created. To be effective, this category had to come to inform public thinking, transcending "esoteric" scientific circles. In this, the mass media were able to play a most useful role. Whatever the misrepresentation entailed in newspaper reports of "making the deaf hear," where a study may in fact have been based on implantees with considerable residual hearing, such reports probably contributed importantly to the reshaping of public perceptions. The activities of Blair Simmons and of Ellis Douek diverge significantly from this picture. Both remained committed to implanting on a very small scale, and throughout the period with which this paper is concerned both continued to believe that the procedure had to be regarded as experimental. The significance of media "hype" for them was more subtle and more complex. In understanding this different approach, Renée Fox's work on transplant surgeons provides a useful starting point. Fox noted that, despite their common commitment to pushing medicine beyond existing frontiers, "… only some of these men wield their microscopes as often as their scalpels and work with their laboratory dogs as much as with their patients" (Fox and Swazey, 1974). The "experimentalist surgeons" are "more inclined to stress the importance of caution as well as thoroughness in human transplantation and to advocate that it still be confined to a relatively limited number of well-studied patients." The distinction we need to make here is of a similar sort, although more is entailed than differences in personal orientation to innovative surgery. Experimentally oriented otologists confronted different problems and rapidly became embedded in different patterns of collaboration from those therapeutically oriented otologists. Simmons started work again, in 1971, only when he could be sure of adequate collaboration from university colleagues in electrical engineering. At UCSF, ENT chair Sooy's early perceptiveness led to the constitution of an interdisciplinary team in which physiologist Merzenich came to play a central role. In London, Douek's early interest in implantation would soon have been frustrated if he had not made the acquaintance of the phoneticist Fourcin, who himself insisted on the need for a psychologist (Moore) in the team. The groups so constituted differ widely in structure from one another, as do their scientific priorities and ultimate clinical goals. Scientifically and clinically the London group, with their commitment to a clear strategy of implant use (the provision of "voice" as a supplement to information which could be read from the lips), as well as to an extracochlear implant, differ considerably from the others. Stressing as they do the experimental nature of implantation, these surgeons were dependent upon positive evaluation in biomedical research circles. Funding by NIH and MRC was vital for Simmons and Douek, and negative decisions could have put paid to their work. This was a quite different situation from that in which House and Chouard worked, for their work was dependent

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Sources of Medical Technology: Universities and Industry upon quite different financial sources, and upon the collaboration of audiologists and speech therapists, not physiologists and psychologists. The "experimental" and the "clinical" approaches have not easily coexisted, and have sometimes sought to undermine each other. After all, if the technology is experimental (according to some), how convincingly can it be argued in public (by others) that "the deaf can be made to hear"? The "experimentalists" contested the attempts of "clinicians" (in their view premature) at forming a category of "potential implant candidates" in the public consciousness. Thus, where Michelson in his 1971 papers and House in his 1973 paper with Urban were already referring to those implanted as patients, Simmons continued to speak of subjects as late as 1979 (Simmons, 1979).13 In a variety of ways the status of the procedure (see above) and the primacy of scientific experiment versus doing and seeing were being debated. When, at the 1973 meeting, Nelson Kiang argued that "while it is true that preconceived ideas can sometimes obstruct progress, it cannot be reasonable to ignore basic knowledge about how a system functions in trying to design replacement parts," a representative of the Utah group (W. H. Dobelle)14 responded: I think a recent remark made in my presence by "Pim" Kolff, inventor of the artificial kidney, is very important and bears repeating. When asked about the fact that, after 30 years, the artificial kidney was still not fully understood, he replied, "If I really worried how it worked, I would still be studying membrane transport in cellophane, instead of building the first artificial kidney." I feel the same way about the auditory prosthesis. If it works, I will take it. Auditory physiologists like you, Dr. Kiang, can then try to explain why (Dobelle, 1973). Related to this is a contest over the basis of authority in the emergent field. Douek offers a clear illustration of this contest. He tells of a conference which took place in the United States, at which Dr. House asked to be the first to speak: And he got up and he said, "Before we present our papers I think each one of us has to say first of all how many cases he has implanted. Because that would give us a clue as to the validity of their findings." Now everybody else crumbled, because he had implanted 300 people, and everybody else had implanted 20 or something like that. But I was the second to speak. And I scotched it for ever. I got up and I said, "I think that I have to explain to you first of all what we are doing, our team in London. I have to say that we are deeply grateful to Dr. House because he has really made it possible for all of us to do the work. 13   Curiously, the Fourcin paper of this same year (Fourcin et al., 1979) is actually inconsistent in this respect, using both terms at different points in the paper! 14   W. H. Dobelle worked in the Institute for Biomedical Engineering at the University of Utah, and was himself involved in experimental studies of electrical stimulation at this time. Within this institute, and inspired by Willem Kolff, work was proceeding in parallel on a number of artificial organs and limbs.

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Sources of Medical Technology: Universities and Industry None of us would have any funding at all if it hadn't been for the publicity with which he is surrounded.… This is true.… We are grateful. He also implants vast numbers of people.… We don't do that. We are a research team, and we are paid by the Medical Research Council to do research, not to treat people.… Now if you have come here to buy an implant, buy Dr. House's. He can sell it.… But what we are doing is the research to give you the implant of tomorrow" (interview with Ellis Douek, London, May 1992). CONCLUSIONS A theoretical starting point for this reconstruction of the early history of cochlear implantation was the idea, derived from earlier work, that the lack of preexisting structures of provision and of appropriate devices for the sensorineurally deaf would present innovators with special problems. My earlier work on diagnostic imaging devices (Blume, 1992) had suggested that assembling the necessary variety of skills and competences, securing agreement as to how (and among whom) the value of the new technique was to be assessed, establishing what kind of industrial expertise provided commercial advantage—all of these things would be problematic. And so they turn out to have been, but also in ways that could not have been predicted on the basis of the earlier work. I have structured this account around the notion of "establishing clinical feasibility" because it seemed that this was the central accomplishment of the early period (and specifically of the 1970s). Those committed to the new technology were obliged to demonstrate, to the satisfaction of those concerned, that cochlear implantation seemed likely to provide benefits to the hearing-impaired. Who were "those concerned?" In the case of diagnostic imaging devices the question was rather simple, given the professional control that radiologists exercise over the production and interpretation of diagnostic images. In the present case matters are less simple, since the range of professions concerned is larger (otologists, audiologists, and speech therapists, among others). Moreover, and most important, deaf or deafened individuals also have to come to see the new device as of potential value to them. Because of this, accounts of the technology in the mass media, emphasizing the rediscovery of bird song or music or hearing the voice of one's child—however exaggerated the accounts may have been—played a vital role. "Establishing clinical feasibility" could not take place, as it did in the case of diagnostic imaging devices, in the pages of scientific and professional journals alone. That, of necessity, made it a more difficult process. Some of those involved (including both leading members of the medical profession and leading biomedical researchers) were unhappy at this, and felt this broadening of the context of debate to have been premature and improper. The vast force of public opinion, dominated as it is by a passionate desire to see medicine vanquish deafness and all other "ills" that flesh is heir to, was all too readily mobilized. Otologists who saw cochlear implantation as a potentially

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Sources of Medical Technology: Universities and Industry valuable, but still experimental, technology had no need to recruit large numbers of implant candidates. What they needed was complex networks of scientific collaborators, to enable them to develop prostheses as safe, as effective, and as fitted to the job as was possible. Groups established along these lines not only differed profoundly from the more "therapeutic" groups but also among themselves. Combinations of expertise differed and were typically more fluid, and the relative emphasis given to different problematizations reflected scientific backgrounds. Whereas the therapeutic groups typically sought at an early stage to have a suitable device fabricated for implant, these experimental groups typically entered hesitantly and slowly into licensing agreements. It is therefore difficult simply to characterize the interdisciplinarity of work on cochlear implantation. It was the first group—always willing to run ahead of, and even ignore, the scientific evidence—who, as it were, made the running. They it was who can be credited with securing a degree of professional support for implantation, and for attracting the interest of industry, by 1982. The field was starting to grow rapidly, so that by this time more than 200 people had been implanted (160 by House and his collaborators alone). A few words are necessary by way of epilogue. Implicit in all the work we have discussed has been an unquestioned identification of deafness with pathology of the organ of hearing. The deaf are frequently referred to as "patients," even though few profoundly deaf adults seek medical help with their deafness. Coincidentally or not, by the early 1980s a quite different perspective on deafness was gaining credibility, largely thanks to work by linguists demonstrating the complex morphological and syntactic structures of the sign languages of the deaf (Grosjean, 1982). This work provided the basis for renewed claims on the part of the deaf to be regarded as, not a collection of hearing-impaired individuals in need of medical help, but a linguistic community. From this perspective cochlear implantation has come to be seen as a threat: exemplifying precisely the medical/pathological view of deafness that has to be opposed. It is House, who had become the hero of the story that otologists tell, who is the principal villain in this alternative rendering. The public at large, however, can more readily identify (or empathize) with House's "patients" than with Simmons' "subjects." The media, too, prefer to present technological medicine as a series of wondrous achievements, so that the "intrepid pioneer'' and not his cautious critics attracts the popular following. Yet despite approvals by the U.S. Food and Drug Administration (in 1984 and in 1990), early assessments of the numbers who would seek cochlear implantation have proved to be wildly high. No one involved, in the 1970s, remotely suspected that the deaf would not come forwards in droves. No one involved had the slightest notion that the deaf could conceivably perceive their deafness in terms other than those of medicine. It is only recently that an alternative history of cochlear implantation—as a new chapter in the oppression of deaf language and culture—has begun to be written (Lane, 1992).

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Sources of Medical Technology: Universities and Industry REFERENCES Albinhac, D. 1978. Les implants cochleaires: Contribution à l'histoire de l'experimentation humaine. Thèse, Ecole Nationale de la Santé Publique, Rennes. Andreef, A. M., Volokhov, A. A., and Gersuni, G. V. 1935. On the electrical excitability of the human ear. On the effect of alternating currents on the affected auditory apparatus. Journal of Physiology USSR 18:250. Ballantyne, J. C., Evans, E. F., and Morrison, A. W. 1978. Electrical Auditory Stimulation in the Management of Profound Hearing Loss. Supplement to Journal of Laryngology and Otology. Ballantyne, J. C., Evans, E. F., and Morrison, A. W. 1982. Electrical auditory stimulation in the management of profound hearing loss. Journal of Laryngolgogy and Otology 96:811. Bilger, R., Black, F., Hopkinson, N., et al. 1977. Evaluation of patients presently fitted with implanted auditory prostheses. Annals of Otology, Rhinology, and Laryngology 86(suppl. 38):92–140. Blume, S. S. 1992. Insight and Industry. Cambridge, Mass.: MIT Press. Bordley, J. E., and Brookhouser, P. E. 1979. The history of otology. In: L. J. Bradford and W. G. Hardy, eds. Hearing and Hearing Impairment . New York: Grune and Stratton. Chouard, C-H. 1973. Entendre sans Oreilles. Paris: Robert Laffont. Chouard, C-H., and MacLeod, P. 1976. Implantation of multiple electrodes for rehabilitation of total deafness: Preliminary report. Laryngoscope 86:1743. Davis, H. 1935. The electrical phenomena of the cochlea and the auditory nerve. Journal of the Acoustical Society of America 6:205. Djourno, A., and Eyries, C. 1957. Prosthèse auditive par excitation électrique à distance du nerf sensoriel à l'aide d'un bobinage inclus à demeure. Presse médicale 65:63. Dobelle, W. H. 1973. Discussant remarks. Annals of Otology 82:517. Doyle, J. B., Doyle D. H., et al. 1963. Electrical stimulation in eighth nerve deafness. Bulletin of the Los Angeles Neurological Society 28:148–150. Fourcin, A. J., Rosen, S. M., Moore, B. C. J. et al. 1979. External electrical stimulation of the cochlea: Clinical, psychophysical, speech-perceptual, and histological findings. British Journal of Audiology 13:85. Fox, R. C., and Swazey, J. 1974. The Courage to Fail. Chicago: University of Chicago Press. Garud, R., and van de Ven, A. H. 1989. Technological innovation and industry emergence: The case of cochlear implants. In: A. H. van de Ven, H. L. Angle, and M. S. Poole, eds. Research on the Management of Innovation: The Minnesota Studies. New York: Harper & Row. Grosjean, F. 1982. Life with Two Languages: An Introduction to Bilingualism . Cambridge, Mass.: Harvard University Press. House, W. F. 1973. Discussant remarks. Annals of Otology 82:516. House, W. F. 1985. A personal perspective on cochlear implants. In: Schindler and Merzenich, eds. Cochlear Implants. New York: Raven Press, p. 15. House, W. F., and Urban, J. 1973. Long-term results of electrode implantation and electronic stimulation of the cochlea in man. Annals of Otology 82:504.

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Sources of Medical Technology: Universities and Industry Jones, R. C., Stevens, S. S., and Lurie, M. H. 1940. Three mechanisms of hearing by electrical stimulation. Journal of the Acoustical Society of America 12:281. Jongkees, L. B. W. 1982. Wat Bleef, Wat Verdween. Amsterdam: University of Amsterdam. Kiang, N. Y. S., and Moxon, E. C. 1972. Physiological considerations in artificial stimulation of the inner ear. Annals of Otology 81:714. Lane, H. 1992. The Mask of Benevolence: The Disablement of the Deaf Community in America. New York, N.Y.: Knopf. Lurie, M. H. 1973. Participant remarks. Annals of Otology 82:513. Merzenich, M. M., and Sooy, F. A., eds. 1974. Report on a Workshop on Cochlear Implants. San Francisco: University of California, San Francisco. Michelson, R. P. 1971a. Electrical stimulation of the human cochlea. Archives of Otolaryngology 93:317. Michelson, R. P. 1971b. The results of electrical stimulation of the cochlea in human sensory deafness. Annals of Otology 80:914. Simmons, F. B. et al. 1973. A functioning multichannel auditory nerve stimulator. A preliminary report on two human volunteers. Acta Otolaryngologica 87:170. Simmons, F. B. 1985. History of cochlear implants in the United States: A personal perspective. In: Schindler and Merzenich, eds. Cochlear Implants. New York: Raven Press. Simmons, F. B. et al. 1964. Electrical stimulation of the acoustic nerve and inferior colliclus in man. Archives of Otolaryngology 79:559. Simmons, F. B. et al. 1965. Auditory nerve: Electrical stimulation in man. Science 148:104. Simmons, F. B. 1985. History of cochlear implants in the United States: A personal perspective. In: Schindler and Merzenich, eds. Cochlear Implants. New York: Raven Press, p. 1. Stevens, S. S. 1937. On hearing by electrical stimulation. Journal of the Acoustical Society of America 8:191. Thornton, A. R. D., ed. 1977. A Review of Artificial Auditory Stimulation . Southampton, England: Institute of Sound and Vibration Research.