North Texas
Cochlear Implant Program
Cochlear Implant Information Index -
General Information -
Internal Components -
External Components
Speech Processing -
Warranty/Loss Information -
Other Resources
North Texas Cochlear Implant Program
Updated 5-23-00
General Information
Over the past decade, the effectiveness
of cochlear implant systems has been demonstrated with thousands of patients
using a variety of different systems.
During the pre-evaluation period, the doctor will look at the CT scans
to determine the orientation and size of the cochlea. This examination might influence the type of cochlear implant the
doctor recommends.
The North Texas Cochlear Implant
Program is able to offer each of the following devices to candidates for
cochlear implantation.
A. Cochlear Implant Manufacturers
Manufacturer Name = Advanced Bionics Corp.
Cochlear Implant Name = Clarion S-Series/Clarion Hi-Focus
Advanced Bionics evolved from the second largest heart pacemaker
manufacturer and the worlds largest manufacturer of implantable and external
insulin pumps
Clarion was introduced in 1991, and was approved by the FDA for
use in adults in 1996 and for children in July, 1997
Manufacturer Name = Cochlear Corporation
Cochlear Implants = Nucleus
24/Nucleus 24 Contour and the Nucleus 22
More than 20,000 people worldwide have obtained a Nucleus
cochlear implant system, including over 9,000 children
Cochlear developed the Nucleus 22 in 1982 and began implanting
children in 1986. The Nucleus 24 system
was approved by the FDA for use in adults and children in 1998.
Cochlear was the first to bring a multichannel behind-the-ear
(BTE) speech processor to the market
Manufacturer Name = Medical Electronics (MED-EL)
Cochlear Implants = Combi
40+
MED-EL has been developing cochlear implant technology since the
early 1980s
As of November 1999, over 200 people in the United States have
been implanted with a MED-EL device.
Over 2000 patients have been implanted with this device in other
countries. Investigational clinical
trials are now being conducted for this device.
MED-EL offers two additional internal cochlear implant arrays for
persons with severe cochlear ossification
B. FDA Approval
Cochlear implants are medical devices
which must be regulated by the Food and Drug Administration (FDA). In order to be approved by the FDA, each new
device must undergo clinical investigation at a specified number of cochlear
implant clinics. The clinical investigations
and the FDA approval which may follow, are typically completed separately for
adults and children.
Depending on whether a device has been
FDA approved or is still under investigation may make a difference as to who is
a candidate to receive the implant, how often they must visit the clinic, and
whether insurance companies will cover the costs of the procedure.
Advanced Bionics Corp.-
Clarion S-series has
FDA approval for adults and children 18 months of age and above
Clarion Hi-Focus is currently under clinical trials for adults and
children 18 months of age and above
Cochlear Corp. -
Nucleus 24 has FDA
approval for adults and children 18 months of age and above
Nucleus 24-Contour currently under clinical trials for adults and
children 12 months of age and above
Nucleus 22 was widely
used until 1998
MED-EL -
Combi 40+ currently
under FDA investigation (clinical trials) for use in the United States for
adults and children 18 months of age and above
C. Earliest Age for Implantation
Since speech and oral language skills
develop more easily when a child hears spoken language during the first years
of life, an early decision regarding the use of a cochlear implant may allow
the greatest advantage of the critical period for oral language development.
Advanced Bionics Corp.- Clarion
minimum
age for implantation = 18 months of age
Cochlear Corp. - Nucleus 24
minimum age for
implantation = 12 months of age
MED-EL - Combi 40+
minimum age for implantation = 18 months of age