Chapter V, AllHear, Inc.

I REMEMBER ALL TOO CLEARLY the frustration I felt when, in 1987, I had such trouble getting anyone to consider the development of a miniaturized processor device, one which could be worn entirely on the head, in a fashion similar to behind-the-ear hearing aids.

Figure 9. The AllHear OTH
(on the head) external sound
processor, at its approximate
actual size (30 mm, 1.15 inches).

3M had quit the field of implants, and sold their ownership of the 3M/House device to Cochlear Corporation. The House Ear Institute had decided not to pursue miniaturization, in spite of the considerable work which had been done there in pursuit of this goal. On approaching Cochlear Corporation, it was made clear to me that they had other plans. With the prevailing climate which existed in implant research, the possibilities for future short electrode devices seemed all but extinguished.

For this and many other reasons, it was a difficult time for me, one during which progress seemed impossible. I determined, nevertheless, that when my circumstances permitted I would pursue the goals which the reasoning and research I have outlined above led me to accept. That is, I felt strongly that we needed implants which had simple, short, efficient electrode systems which could accept and transmit a wide variety of signals.

Beyond this, it was clear to me from many years of interaction with my implant patients that an external processor which was as small and sophisticated as possible was a design necessity. For some reason there was considerable resistance to this idea, as I've indicated.

Figure 10. Details of the AllHear OTH external processor, in side view.
Different magnetic inserts may be used to vary the strength of the magnet
which holds the unit on the patient's head. The package is designed so
that it can accept different electronics packages easily. In this manner,
external processors with new processing schemes can be produced
without totally changing the basic design.

Figure 11. The AllHear ITH (in the head) single, trans-cochlear electrode system,
cutaway side view. The internal magnet is matched by the magnet in the OTH,
and these hold the external unit in place. Currents induced in the coil are
transmitted through the electrode into the cochlea, and return
through the common ground (not seen in this view).

Figure 12. The AllHear ITH electrode system, external top view.
The main portion of the ITH, in the sealed housing, is implanted under the
skin, just behind the ear. The longer electrode is inserted in the cochlea.

In 1988 I started work with Steve Waldron, of Altair Corporation, designing an external processor which would mate with the existing 3M/House electrode system. This work took more time than I wanted it to, but in 1992 it resulted in the first all on-the-head (OTH) external processor unit for cochlear implants. The FDA considered this a non-significant risk device for existing 3M/House patients, since it did not require us to implant a new electrode, and this designation allowed us to quickly offer the processor unit to about 25 of these patients.

The next step was to create a new electrode system, one which had the characteristics that current research has demonstrated are necessary. By December of 1994, the first of these devices was implanted in a patient.

Deafness is not restricted to countries with a high standard of living, and thus if we are to speak of truly universal access to the birthright of hearing, we must consider the whole world. The current high cost of cochlear implants represents an insurmountable barrier to those in more restricted circumstances, and so we must not only increase the quality of implants, we must work to reduce the cost.

My experience in working with major companies on implant production has been very instructive. Large companies have large budgets and must have to maintain their complex structures. These budgets serve to drive up costs.

Simple designs also keep costs in line. Newly developed integrated circuits for hearing aids can be utilized to produce miniaturized processors which are capable of advanced sound manipulation and signal delivery, and yet, because of the economies of scale, these circuits are becoming very inexpensive.

Clearly, pursuit of the goal of universal access and success cannot be undertaken with expensive implants. Therefore, AllHear is dedicated to providing high-quality implants at the lowest possible cost.

Thus it has turned out to be something of a blessing that established medical device manufacturers chose not to listen when I asked them to pursue short-electrode implants, for it has given us a chance to develop a company from the ground up which can deliver quality yet keep internal costs low.

I look forward to having many new adventures in the field of cochlear implants. It is clear that cochlear implants will be used more and more widely, and for those with an increasing variety of hearing problems. Whereas in 1957 this was all an impossible dream, today it has grown into an every-day reality.

I guess its time for more impossible dreams, and I hope to continue to be blessed with them.

Chapter IV, Auditory Success < PREVIOUSNEXT > Footnotes