It could have been #Deafness forever, but this #BionicEar changes thing for this young man... - http://clapway.com/2015/08/17/thanks-to-the-bionic-ear-a-five-year-old-boy-can-hear-for-the-first-time-322/

Caiden Moran, an active and curious five-year-old is a success story for many children like him who suffer from deafness. He is able to hear sounds for the first time because of an auditory brainstem implant (ABI) commonly called a bionic ear.

A clinical trial uses bionic ear technology for deaf children between 2 and 5 years

The ABI or ‘bionic ear’ developed by the House Research Institute in California targets deaf children who are born without cochlea. The cochlea is the part of the ear that senses sound and conveys this information to the brain for sound processing. Therefore, in infants born without cochlea, traditional cochlear implants are futile; they require strategies that alter sound processing at the brain level. This formed the basis for the 5-year clinical trial approved by the FDA and backed by funding from the National Institutes of Health (NIH) National Institute on Deafness and Communications Disorders (NIDD).

This multi-institute trial began in 2014 in conjunction with the Children’s hospital at Los Angeles and the Keck School of Medicine at the University of Southern California. It recruits children between 2 and 5 years of age who have been unresponsive to standard treatment such as hearing aids and cochlear implants. So far 5 out of the proposed 10 candidates have successfully received implants.

How does the bionic ear work?

The ABI attaches to the side of the head and consists of a microphone and a transmitter that converts external sounds to electrical signals. A receiver implanted in the brain stem receives the electrical signals and stimulates the auditory neurons present in the brain. This process therefore mediates hearing by circumventing the inner ear entirely.

Bionic ears have been approved for use in adults with brain tumors on the hearing nerve, but were found to be minimally effective. It is hoped that younger kids like Caiden would respond better to them given the fact that their brains are more adaptable.

The outlook for children implanted with the bionic ear

Caiden was implanted with the device in January 2015, and has shown positive signs of responding to auditory cues in his therapy sessions. Scientists believe that in case of auditory implants, the earlier you intervene, the better the chances of the brain to learn and respond to sounds. Caiden has a long road to recovery ahead; his brain is slowly getting used to the concept of sound and reacting to it. Nevertheless, he’s part of the nascent yet exciting history of the ‘bionic ear’.

 > If you’ve a hankering to learn more on Deaf Culture, check this one out.

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Thanks to the Bionic Ear a Five-Year Old Boy Can Hear for the First Time

Inconsistent Standards for FDA Approval of High-Risk Medical Devices - http://clapway.com/2015/08/11/inconsistent-standards-for-fda-approval-of-high-risk-medical-devices123/

A study examining the clinical studies backing the FDA approval of high-risk medical devices revealed a large variation in their number and quality, raising valid concerns about the approval process.

WHAT ARE HIGH-RISK MEDICAL DEVICES?

A medical device is an apparatus that diagnoses, cures, lessens, treats, or prevents disease by affecting the structure and function of the human body. It differs from a drug in that it achieves its intended effect without any chemical action on the body. The FDA stratifies medical devices into different categories based on the risks they pose. The high-risk category of medical devices are defined by the FDA as those that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of such devices include pacemakers, implanted weight-loss devices, medical imaging analyzers and cochlear implants. These devices face the toughest regulatory controls for approval from the FDA, which employs a Premarket Approval (PMA) pathway to establish the safety and effectiveness of the device.

In the study conducted, clinical studies of 28 such high-risk medical devices that received approval via the PMA pathway between 2010-2011 were tracked throughout the product lifecycle. This means studies beginning at the pre-market level required for approval, to the post-market studies that monitored the long-term outcomes of approved devices. The authors identified 286 clinical studies for the 28 devices, with 82 pre-market and 204 post-market studies, with obvious asymmetry in the number of pre-market clinical studies. The FDA used roughly one pre-market study per device to grant approval. A majority of the post-market studies too were initiated by the manufacturer (60%) and not mandated by the FDA (11.5 %). Only 6 of the 33 FDA-mandated post-market studies were reported completed. No post-market studies were uncovered for 5 of the devices, and three or fewer for 13 devices. Half the studies did not compare the device’s performance to an existing one.

What emerges from an analysis like this is the realization that there is a marked shift in the burden of proof required at the pre-market level to post-market surveillance. The risk to benefit ratio for high-risk devices are often understandably higher than others and might require an approach tailored to each specific device. While it is important to monitor the long term population based effects of high-risk medical devices, lowering the bar for their approval seems hardly the right way to go.

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Inconsistent Standards for FDA Approval of High-Risk Medical Devices 

Gene Therapy Could Be the Key to Deafness - http://clapway.com/2015/07/09/gene-therapy-could-be-the-key-to-deafness798/

A study published in the Journal Science Translation Medicine has discussed the successful restoration of hearing in mice with genetic forms of deafness by using gene therapy. The research offers hope for children born with genes that cause profound hearing loss.

70 DIFFERENT GENES CAN RESULT IN DEAFNESS

This has opened the doors for researchers to try the same on humans. More than 70 different defective genes are known to result in deafness. The scientists in this study focused on one gene called the TCM1. It is responsible for between 4-8 percent of cases of deafness and plays a central role in hearing by coding for important inner ear protein.

HARVARD MEDICAL SCHOOL’S GENE THERAPY PROTOCOL ISN’T READY

Boston Children’s Hospital and Harvard Medical School has said that their gene therapy protocol isn’t prepared for clinical trials. They need to tweak it a little in order to use it but there are sure that this could be used for therapeutic use in humans.

GENE THERAPY TESTED IN TWO TYPES OF MICE

The researchers tested gene therapy in two types of mutant mice. One type of mice had the TMC1 gene completely deleted and is the perfect model for the recessive TCM1 mutations in humans. Children who have two mutant copies of TCM1 have acute hearing loss from a young age, around two years old. This treatment was tested on two strains of mutant mice, representing different forms of TCM1-related deafness in humans. One mouse had no functioning TCM1 gene, and children with this kind of recessive genetic defect go deaf from a very young age.

The other strain, called Beethoven, had a less common form of TCM1 deafness caused by one copy of the paired genes not working. This “dominant” defect causes children to go deaf gradually from between the ages of 10 to 15.

In the recessive deafness, gene therapy with TCM1 restored the ability of sensory hairs to respond to sound producing a measurable electrical current and restored activity to the auditory part of the brainstem. In the dominant deafness model, gene therapy with a related gene, TCM2 was a success at the cellular and brain level and restored hearing partially, as proven in the startle test.

The researchers of this study have envisioned that deaf patients will have their genome sequenced and a precision medicine treatment injected into the ears to restore hearing. This form of therapy and restoration of hearing might be the replacement for the traditional cochlear implant.

Researchers restored the hearing of deaf mice by injecting a virus with the healthy gene into their inner ears. This gene therapy cure was successfully tested and could be offered to human patients in a little under five years.

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Gene Therapy Could Be the Key to Deafness

Crossing the bridge of language in deaf culture.- http://clapway.com/2015/06/22/my-2-wonderful-years-in-the-deaf-culture/

Austin has an incredible deaf community. We have the Austin School for the Deaf and a great Interpreter program at Austin Community College. While attending college, I was required to take a foreign language and I decided on American Sign Language. It’s something that was on my bucket list of things to learn and I was so excited at the opportunity to do so.

I took the class for 4 semesters and it came very naturally to me. I’m an animated speaker so I use my hands when I talk anyway; why not be saying something with them too? I’ve made friends with so many deaf students and tutors from school, and it honestly is something that still excites me today to be able to talk to a deaf guest when they come into my restaurant.

Many people don’t know that being deaf is not a “handicap.”

To put it simply, deaf culture is just like any other culture where there might be a language barrier. Just as the Germans speak German and we speak English, deaf people speak ASL. Well not speak, but you get my point. Some people actually do speak.

I had a guest back when I was bartending who spoke to me and ordered her meal and drinks and I didn’t notice anything about it. She turned to look at the menu and I asked her a question. When she didn’t respond, I realized she didn’t hear me at all.

It’s actually more common for older deaf people to have some speaking abilities because for many years, their parents sent them to schools that taught them to be like us instead of teaching them how to communicate in their own language; to communicate in a way that they could instead of forcing them to pretend they could hear.

At the time, it was definitely seen as a handicap and parents didn’t want their children to be different. The culture was something that was still new and being learned about. Also, let’s just clear this up right now: if someone is deaf, it does not mean they can read your lips. That’s actually quite an offensive assumption to a deaf person.

Deaf people feel music much more than hearing people.

The most interesting thing I learned about deaf culture (and I really learned so many interesting things) was how they “hear” things. As an ASL student, we were required to attend different deaf events to acclimate ourselves to the culture. One of the first events I went to was an after party for the deaf school’s homecoming game. They had a hardcore band that took the stage by storm! These kids were so good. I was so amazed, and still learning, and didn’t even think of the fact that they could feel the sound vibrations on the stage. That’s how they kept tempo. They were awesome.

“Hearing” Gadgets Galore! Deaf Technology has advanced so much.

There are many different devices that deaf people use to communicate. First, let me mention cochlear implants, which have given many members of the deaf community another option. Basically, these little guys are implanted behind or above the ear and give the ear a sense of sound. I think, as a hearing person, one of the most convenient forms of technology to come out for distance communication is the FaceTime function on the iPhone. For many years, technology has been trying to encompass this concept and there have been devices created with this function, but none that I’ve seen (again, as a hearing person) that is as able and at-your-fingertips.

Earlier this year, the FDA approved a gadget that allows deaf people to “hear” with their tongue. It may not immediately sound like the most appealing way to communicate, but the science behind it is pretty cool. I’m sure your first though was someone licking all over a cell phone-like device. Maybe that was just me?

The FDA has also recently approved a device that will similarly help a blind person to “see.” This new form of “hearing” or “seeing” doesn’t require a surgical implant, unlike the cochlear implant, and is expected to be more affordable. In the same way that the implant sends signals to stimulate the auditory nerve, this new device will take sounds and convert them into patterns and impulses which will then be sent to a smart retainer held the in the mouth. The retainer, when pressed by the tongue, will send out tiny impulses in patterns to stimulate the tongue’s nerves. From there, the signals are relayed to the brain. The similar device made for the blind does the same thing, but will send different patterns for different colors in an image. It records with a camera, attached to a pair of glasses, the person’s surroundings and sends the signals to the mouthpiece.

Crossing The Bridge of Language

I know I’m excited to see how this device adds to my local deaf community. Technology has become such an incredible resource to many different cultures and now even more so to the deaf culture. While most of the technologies mentioned take time to adjust to, and require some training, it’s awesome to see more and more options become available to help bridge the language barrier between so many different cultures.

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My 2 Wonderful Years in the Deaf Culture