September
2006
Editor:
Things have been pretty quiet on the implantable hearing aid front for
awhile. Now they're heating up again with this announcement of a clinical
research study from Otologics.
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Otologics,
LLC, a Boulder, Colorado-based developer of hearing devices is currently
enrolling patients in a clinical research study for a new fully
implantable hearing device.
For many
people, a hearing aid restricts activities because it has to be removed
before participation. It can prevent them from swimming, aerobic
activities, or playing tennis, and can interfere with sleeping and
showering because of perspiration or other moisture. In short, it can make
the simple, enjoyable things in life more difficult.
A new
investigational, fully implantable hearing device from Otologics is now
being evaluated. Unlike traditional hearing aids, this device is
surgically implanted under the skin. Nothing is worn in the ear canal and
no part of the device is visible externally.
Patients
18 years of age or older, with moderate to severe hearing loss, who are
currently wearing a hearing aid and who speak English, may be eligible to
participate in this clinical research study. The sponsor is covering
physician and surgical costs. Participants will be responsible for the
cost of the actual hearing device, which is $12,500, as well as personal
transportation for clinic visits.
Call
1-866-394-7320 for more information about the clinical research study for
this investigational, fully implantable hearing device.
Otologics,
LLC is a Boulder, Colorado-based medical device company, which is
dedicated to developing implantable hearing devices designed to enhance
the quality of life of the hearing impaired. Otologics, LLC is located at
5445 Airport Blvd Boulder, CO 80301. For more information contact
Annemarie Osborne at MediaInquiries@Otologics.com or (949) 916-1147.
~~~~~~~~~~~~~~~~~
September 2006
Editor: Here's more news on
Carina, the fully implantable hearing device (note that they don't call it
a hearing aid) from Otologics. It appears to be interesting and promising
technology.
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Otologics, a medical device
manufacturer based in Boulder, Colorado, is the developer of a
revolutionary, fully implantable hearing device for the moderate to
severely hearing impaired population.
A special course entitled
Otologics Implantable Hearing Device will be presented at the European
Academy of Neural Otology on Friday, September 22 at 6:30 with a special
guest appearance from one of the patients implanted with the Carina
device. The device will be presented again on Saturday, September 23rd
from 11:15 to 12:00. The company will demonstrate how the device is
implanted and how it works. Video footage of an actual implantation will
also be shown during the presentations.
Carina is not a hearing aid nor
a cochlear implant, this revolutionary technology is a fully implantable
middle ear prosthesis that completely bypasses the ear canal and eardrum,
overcoming the anatomical and physical limitations that prevent
conventional therapy from providing maximum hearing functionality.
This device has been implanted
in patients with severe hearing loss and has significantly improved the
quality of life for these individuals. Carina delivers a high fidelity
signal directly to the middle ear, providing improved function, comfort
and convenience over traditional hearing devices.
A hearing aid can restrict
activities for many people. It can prevent them from engaging in
activities like swimming, aerobics, tennis and even showering, because of
perspiration or other moisture. Carina is designed to help people enjoy
their favorite activities without any lifestyle restrictions.
~~~~~~~~~~~~~~~~~
December
2006
The
new device consists of a small sound processor that contains batteries
and has two wires attached. Surgeons insert the processor -- about the
size of a baby's hand -- beneath the skin behind the ear. Both wires are
threaded through skull bone to the middle ear, which is behind the
eardrum. The wire that senses sound vibrations entering the ear is
attached to the anvil, or the middle ear bone. The vibrations are
transformed into electrical signals and sent to the processor, which
refines the sound and sends it along the other wire to the stirrup --
the ear bone closest to the cochlea -- which the brain uses to interpret
sound. The device is for people with mild to severe hearing loss who are
not comfortable with external hearing aids. It does not work on people
who are deaf and is not for children. Full
Story
~~~~~~~~~~~~~~~~~
Otologics'
Carina systems, which are implanted under the skin, will be priced
between $12,000 and $15,000 each when they reach the American market in
2009. Implant surgery costs an additional $4,000 to $8,000 per system.
According to Bedoya, the Carina system offers convenience, comfort,
cosmetics and better sound quality than traditional hearing aids. The
implanted portion of the Carina is a capsule containing a microphone, a
digital signal processor and a rechargeable battery with a projected
20-year life. There is no external indication of its presence, a
significant advantage for those who believe that evidence of a hearing
impairment will detract from their image or professional effectiveness.
Full
Story
~~~~~~~~~~~~~~~~~
August 2007
Hearing aids help millions of people, but many resist
them because they think wearing one carries a social stigma. Hearing aids
also have serious lifestyle limitations: the hearing impaired can't wear
them while showering or swimming, and most models are hard to wear while
sleeping. Now, a new kind of hearing aid that aims to overcome these
problems is in clinical trials. It's invisible and waterproof because all
of its circuitry--including its battery and microphone-- is in the user's
head. Developed by Otologics, of Boulder, CO, the device picks up sound
with a microphone implanted underneath the skin behind the user's ear.
The signal is processed by electronics and sent to a tiny vibrating
piston implanted against the small bones in the middle ear. The bones
transmit the vibrations to the inner ear, which encodes them as nerve
impulses and sends the information to the brain.
Full Story
~~~~~~~~~~~~~~~~~
November 2007
In the past 10 years, improvements in hearing
devices have substantially helped feedback control, widening the frequency
range, and, to some degree, sound quality; however, patients still
experience the stigma and practical problems of using these devices.
Recognizing that stigma and sound quality will always be issues for those
that use traditional hearing instruments, research has pursued a quest to
find an efficient, practical method of middle ear implantation that would
counteract many of the difficulties of hearing aid use. [Ed. This is a
great, comprehensive article!]
Full Story
~~~~~~~~~~~~~~~~~
December 2007
A hearing aid is a straightforward device. Its
microphone collects sound, its electronics amplify it, its tiny
loudspeaker sends the sound into a tube placed in the ear canal, and the
power comes from a disposable battery. There's just one problem: people
hate hearing aids. They get lost. They're hard to wear while sleeping.
They mustn't get wet. They get chewed up by the dog. They're awkward
during sex. . . . . So far, no one's built a fully implantable cochlear
implant. But two fully implantable hearing aids are now in clinical trials
(that is to say, they are considered investigational by the U.S. Food and
Drug Administration and are not yet approved for commercial sale). One,
the Esteem, is built by Envoy Medical of St. Paul, MN. The other, from
Otologics of Boulder, CO, is called the Carina. Hopes are high that they
will be the first successful devices of their kind. Making such things is
a challenge. Where does the microphone go? How is the amplified sound sent
into the ear? What's the power source? And how can it be kept in the body
without leaking?
Full Story
~~~~~~~~~~~~~~~~~
Editor: We've been hearing about the Vibrant
Soundbridge implantable hearing aid for a few years now, and it looks like
it's ready for prime time. Here's the press release about the first
implantation!
~~~~~~~~~~~~~~~~~
January 2008
MED-EL Corporation announced today the first US implantation in the
clinical trial of the Vibrant Soundbridge® (VSB) as a treatment for
conductive and mixed hearing loss using direct round window cochlear
stimulation. The Vibrant Soundbridge is the first US Food and Drug
Administration (FDA) approved implantable middle-ear hearing device to
treat sensorineural hearing loss. Adults with conductive or mixed
hearing loss who have been unsuccessful with traditional amplification may
be candidates for the trial.
Today is the first day that the clinical trial opened in the United
States. The implantation was performed by Jennifer Maw, MD, founder of
Ear and Rehabilitative Services (EARS) Inc in San Jose, Calif.
“I am extremely enthusiastic about this new study,” says Dr. Maw. “This
procedure has the potential to revolutionize how ear surgeons treat
chronic ear disease and hearing loss. Eustachian tube dysfunction limits
the hearing results that patients can achieve with reconstructive ear
surgery, and there are no well-established treatments for this problem. As
this device can mimic the function of the middle ear, we can potentially
help a large category of patients who could not be previously considered
as suitable surgical candidates.”
~~~~~~~~~~~~~~~~~
May 2008
THE IDEA of putting a vibrator on one of little
bones in the middle ear began in Japan over 30 years ago. The
semi-implanted hearing aid was finally invented by a man named Geoff Ball,
who had hearing problems himself. Med-El purchased rights to the
invention, and has been manufacturing it for 10 years, since the first one
was implanted. Although part of it is inside the head, it is not a
cochlear implant - a surgically implanted electronic device that provides
a sense of sound to a person who is profoundly deaf. The cochlear implant
is often referred to as a "bionic ear" that - unlike hearing aids - does
not amplify sound. Instead, this implant, used by many hundreds of Israeli
children and now adults as well, works by electrically stimulating any
functioning auditory nerves inside the cochlea. On the exterior of the
head are a microphone, speech processor and transmitter that enable the
wearer to adjust the sound for quality and amplification.
Full Story
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July 2008
A surgically implanted hearing aid that stays
under your skin is being put to the test in the Bay Area. It could
drastically change the way the hearing impaired lead their lives. A new,
invisible hearing aid being tested in the Bay Area could soon change
thousands of lives. David Steele is an avid swimmer and kayaker. But
there's something he can never forget when he hits the water -- taking out
his hearing aids. "If my hearing aids get wet, that's it, they're dead and
can't be fixed," said Steele. He says just the threat from his own sweat
forces him into a world of silence, during long runs with his fiance.
"Here I am, I am engaged to this wonderful woman and if we go swimming,
kayaking or running, I want to talk to her," said Steele. But now, a
clinical trial going on at the California Ear Institute in East Palo Alto
is attempting to break down that sound barrier for hearing impaired
athletes.
Full Story
