Envoy
Medical
has produced the world's first FDA approved totally implantable hearing
device. It is called the “Esteem”. The
Esteem is a breakthrough in technology that actually utilizes your own eardrum
as the sound collection mechanism rather than using a synthetic microphone. The
results are truly amazing in terms of sound clarity, quality and ease of use.
The
device is completely implanted and completely invisible. No one will notice that
you have an esteem implanted. There
is no need to wear your hair long to cover your ears.
Ease-of-use:
The
Esteem requires no maintenance. There is no device to take out and put on the
nightstand. There are no worries about getting any electronics wet. You can
swim, shower and exercise without worry. The batteries do not need to be
recharged every night. It simply keeps working and working for years on end. The
batteries are tested to last approximately 6 or 7 years if used 16 hours a day
for seven days a week. (Continuous use at very high noise levels may reduce
battery life. The range is 3-9
years) At the end of that time, a minor procedure is necessary to replace the
battery.
Sound
Quality:
The
sound quality and level of amplification has been reported by patients to be
amazing. Because it uses the human eardrum as a microphone, the sound collection
is more natural. Thus, the sound experience is much more natural. There is no
"squealing" feedback that plagues conventional hearing aids usage.
Most patients who have previously tried hearing aids are thrilled with the
improvement from the Esteem.
Surgery:
The
surgery is a very technically complex procedure that involves an incision behind
the ear, and a mastoidectomy approach. A pocket is made for the battery/receiver
unit. Next the hearing bones are prepared to accept the implants. A section of
the incus bone is removed with a laser in order to redirect the incoming sound
to the receiver, so that it can be amplified and be converted to a more powerful
vibration that is sent to the stapes bone via the “driver” device.
The "sensing” device and the "driver" device are
carefully positioned within the mastoid cavity so that the optimal vibration
sensitivity is achieved. The devices are then cemented into place, and then the
system is tested with specially calibrated lasers that predict an excellent
outcome. (If not, adjustments are
generally made until an excellent outcome is achieved.) (There are cases in
which the implant is surgically found to be incompatible. In those rare cases,
the procedure is terminated before any major changes are made in the hearing
bones connections).
The
postoperative period is usually uneventful although some patients have some
discomfort just as they would have with any other surgery. Patients who have
flown into town (usually for the day before surgery) are usually allowed to
leave two or three days after surgery.
Activation:
Activation
is performed by the Envoy field clinical engineer two months after surgery. Some
tests are run to determine device integrity. Once that is done, the device is
activated, generally at an initially lower level. Adjustments may be made later
on to bring the levels higher. That avoids the sudden discomfort that one might
experience coming out of the darkroom into a brightly lit room.
Battery life estimates:
·
4.5 years - 24 hours per day/7 days per week
·
6.5 years - 16 hours per day/7 days per week
·
9 years - 8 hours per day/7 days per week