Changes in Cochlear Implant Candidacy and
Technologies
Here's our report on the Advanced Bionics workshop at ALDAcon 2003 in
Las Vegas. We presented the information from the Cochlear Corporation a
couple of weeks ago, and we'll present the MedEl information next week.
The workshop was presented by Ann Marie Henson.
As cochlear implants (CIs) become better and better, the candidacy
requirements are opened up to include more and more people. The
requirements are based on an assessment of whether or not a person is
likely to hear significantly better with a CI than she currently does
with hearing aids. The current requirements for adults are:
- Healthy adult age 18 or older
- A hearing loss of 70 db or greater in both ears
- Lack of benefit from hearing aids, which normally means a HINT
(Hearing in Noise Test) score of less than 50%. Those people who have
trouble understanding strangers on the phone or those who score less
than 30% on single word tests will probably qualify (score less than
50%) when given the HINT test.
Note that Medicare guidelines have not kept up with those established
by the FDA. Medicare requires a HINT score of less than 30%, rather than
the 50% required by the FDA.
A typical CI implantee can expect hearing thresholds of 20 db to 40
db at all test frequencies, which generally results in greatly improved
hearing compared to the 70 db minimum for CI candidacy.
CI history shows a constant improvement in the hearing ability of
recipients. Early recipients in 1981 scored an average of 12% correct on
the Open Set Easy Sentence test. As unimpressive as that is by today's
standards, it was still a considerable improvement for those people who
scored 0% with their hearing aids. Increasing performance is reflected
in scores of 30% in 1984, 58% in 1989, 77% in 1994, and 85% in 1999.
Advanced Bionics (AB) is committed to ensuring that previous
recipients are able to take advantage of improving technology. One
indication of that commitment is that all of their speech processors are
backwards compatible with previous internal components.
In April 2001, Advanced Bionics changed their internal electronics to
a system called CII. Then in the summer of 2003, they repackaged the CII
into the HiRes 90K. It contains the same electronics, but is easier to
implant.
Their HiRes system features a removable magnet, focusing electrodes
and 90,000 samples per second. It includes 16 high-precision output
circuits, which means that each of their 16 electrodes has its own power
source. This allows all 16 electrodes to be stimulated at the same time.
Other CIs have a single power source, which means that only one
electrode can be stimulated at a time.
Advanced Bionics believes that their sound strategy provides the most
accurate representation of real world sound. It starts with an increased
input dynamic range compared to other CIs. Their input threshold is
automatically adjusted to match the level of environmental sound. The
range is from 25 dBs to 85 dBs. The effective Input Dynamic Range is
80db.
The signal is then processed through the 16 independent channels,
which allows the HiRes system to deliver the full input spectrum. By
comparison, other CIs using the CIS strategy are limited to 800 pulses
per second, which is a low frequency signal.
Advanced Bionics testing indicates that the users do, in fact,
perform better with the HiRes system than with the CIS strategy. Their
studies indicate an average improvement of 14% on the HINT test, and
those with the worst performance using CIS tend to show the most
improvement. Advanced Bionics also thinks that the HiRes system performs
better on music, because of its reproduction of high frequency
components.
Advanced Bionics has recently introduced the Auria ear level
processor, which is worn much like a behind-the-ear (BTE) hearing aid.
It has a new, more comfortable shape, and the same processing
capabilities as the body worn processor. It holds three programs.
One of the options with the Auria processor is the T-Mic, which is
located in the ear canal. This placement allows the use of standard
headphones and allows one to use any telephone (including cell phones)
in a standard fashion.
Advanced Bionics has recently introduced several battery improvements
for the Auria. Their standard rechargeable battery uses a new chemistry
that provides an average of nine hours use on a charge. This battery is
currently available for the Auria, and will be available for older
processors in the spring of 2004. They are also developing new cells
called Power Cell Plus, which are expected to provide an average of 17
hours use.
While some people prefer the ear level processor, those who prefer
the body worn processor cite the following advantages:
- It doesn't fall off as easily as the ear-level processor
- It's easier to plug things in, because you can see the unit.
- The knobs are easier to manipulate.
- It's more comfortable, because there is nothing on the ear.
The CII has Neural Response Imagery, which allows an audiologist to
test the function of the acoustic nerve without user input. This is
especially useful for children.
The Auria has direct connection for connecting audio devices; the CI
and CII have auxiliary earhooks with a connected cable that allow the
attachment of audio devices.
The Phonak wireless system will be available for the Auria in the
spring of 2003, and for the CI and CII in the summer.
The FDA requires the internal components to last for life (defined as
99 years). So far, their reliability exceeds 99%.