Cochlear Nucleus Hybrid L24, a New Combination Implant/Hearing Aid for Sensorineural High Pitch Hearing Loss

Nucleus Hybrid L24 Cochlear Nucleus Hybrid L24, a New Combination Implant/Hearing Aid for Sensorineural High Pitch Hearing Loss

Lots of people suffer from selective hearing loss that allows them to hear low frequency sounds quite well, while the high pitch is severely limited. This is normally due to damaged cochlea and traditional options, like hearing aids and cochlear implants, often don’t do a sufficient job of helping such people hear the world around them. A new, first of its kind system, that combines an implant and a hearing aid into one, has just been approved by the FDA for people with severe or profound sensorineural hearing loss of high-frequency sounds in both ears.

nucleus system Cochlear Nucleus Hybrid L24, a New Combination Implant/Hearing Aid for Sensorineural High Pitch Hearing Loss The hearing aid component of the Nucleus Hybrid L24 Cochlear Implant System from Cochlear Ltd. transmits processed audio to the implant that in turn stimulates the cochlea via a set of electrode leads. This creates a sense of hearing in the higher frequencies, while the hearing aid does more traditional sound processing and amplification for the lower frequencies.

The system also includes a couple optional control devices that allow for tuning of the system to adjust its audio processing and neurostimulation for individual patients

From the FDA’s announcement:

The agency evaluated a clinical study involving 50 individuals with severe to profound high-frequency hearing loss who still had significant levels of low-frequency hearing. The individuals were tested before and after being implanted with the device. A majority of the patients reported statistically significant improvements in word and sentence recognition at six months after activation of the device compared to their baseline pre-implant performance using a conventional hearing aid. The device also underwent non-clinical testing, which included the electrical components, biocompatibility and durability of the device.

Of the 50 individuals participating in the study, 68 percent experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus (ringing in the ear), electrode malfunction and dizziness. Twenty-two developed profound or total low-frequency hearing loss in the implanted ear, six of whom underwent an additional surgery to replace the Nucleus Hybrid L24 Cochlear Implant System with a standard cochlear implant.

While the risk of low-frequency hearing loss is of concern, the FDA determined that the overall benefits of the device outweigh this risk for those who do not benefit from traditional hearing aids.

Here’s more about the system from last year’s FDA presentation by Christine Menapace, Vice President Clinical, Quality and Regulatory Affairs, Cochlear…

FDA press statement: FDA approves first implantable hearing device for adults with a certain kind of hearing loss…

St. Jude’s Prodigy Neurostimulator with Burst Technology

St. Jude's Prodigy Neurostimulator with Burst Technology

St. Jude Medical received EU regulatory approval and is now launching its Prodigy Chronic Pain System with Burst Technology in Europe. The neurostimulator was designed to address challenging patients for whom a traditional spinal cord stimulator (SCS) may not be sufficiently effective, and to prevent paresthesia, a tingling senation, that’s common in SCS users.

Standard neurostimulators for pain management provide a constant rhythm of pulses that mask the electric signals going up the spine. The brain seems to overcome this type of noise and for many patients the pain remains. Moreover, continuous even signals from the stimulator seem to develop a tingling sensation in many patients, some of whom find it more unpleasant than the pain itself. The Burst Technology inside the Prodigy implant allows surgeons to program an irregular pattern of pulses, hopefully making the device more efficient at stopping pain while preventing the dreaded paresthesia.

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CareFusion’s V. Mueller New Line of Bipolar Electrosurgical Tools

CareFusion's V. Mueller New Line of Bipolar Electrosurgical Tools

CareFusion is releasing a new line of customized bipolar electrosurgical devices that include a variety of forceps and scissors. The V. Mueller branded tools can be selected by surgeons to be non-stick, be made of titanium, and have irrigation capabilities.

The bipolar energy delivery to the instrument through a single cord allows for less damage to nearby  tissue while preventing cords from tangling around each other and allowing surgeons easier access around the surgical site.

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Electric Stimulator Guides Neuroplasticity to Treat Tinnitus (VIDEO)

Electric Stimulator Guides Neuroplasticity to Treat Tinnitus (VIDEO)

Tinnitus is a debilitating condition thought to be caused by the brain generating a signal in areas no longer stimulated by the auditory system. The brain’s natural plasticity can potentially be utilized to treat tinnitus, by stimulating adjacent regions of the brain. A new system that works on the auditory cortex to guide neuroplasticity has been developed by MicroTransponder, a spin-off company from University of Texas at Dallas, and the technology is now set to begin clinical trials.

The Serenity System couples an implantable vagus nerve stimulator with a tone generator that plays sounds of various frequencies while electric signals are delivered by the neurostimulator. Stimulating the vagus nerve releases chemicals involved in neuroplasticity, so doing so while playing the tones will hopefully train the brain to correlate the various sound frequencies to their normal areas in the auditory cortex.

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Cook’s Biodesign Duraplasty Graft for Skull-Base Dura Reconstruction

Cook's Biodesign Duraplasty Graft for Skull-Base Dura Reconstruction

Cook Medical is launching its Biodesign Duraplasty Graft for repair of the dura mater that surrounds the brain and spinal cord to prevent cerebrospinal fluid leaks. It’s intended for use to wrap up surgeries at the base of the skull, such as tumor resections, and to stop leaks resulting from disease or injury.

The graft doesn’t swell when exposed to liquid and doesn’t fold on itself to maintain proper shape when implanted. It can be used with or without sutures.

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Bypassing Paralysis with a Neural Link Across Spinal Cord

Bypassing Paralysis with a Neural Link Across Spinal Cord

Spinal cord injuries end up paralyzing people because of a small break in the neural electrical connection going down the spine. Bypassing the break with some man-made electronics could be a potential solution.

Researchers at Cornell University linked the brain of one monkey to the spinal cord of another so that when neural activity linked to arm movement was recorded in the brain of the first monkey, it was relayed to the spinal cord of the other, making it move a joystick even though sedated. Though this technology is certainly not ready for prime time, the basic components that allow for thought controlled movement of paralyzed limbs due to a spinal cord injury are essentially here.

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MR-Safe, CT-Compatible Pinless Headrest is Gentle on Scalp During Neurosurgery

MR-Safe, CT-Compatible Pinless Headrest is Gentle on Scalp During Neurosurgery

IMRIS, a company specializing in producing surgical suites that feature CT and MRI scanners that slide in and out as necessary, has released the world’s first MR-safe and CT-compatible adjustable horseshoe headset for neurological surgeries. The device allows for positioning and repositioning of the head during a procedure and can be used within any tomograph without having to switch to a special imaging headrest.

The device doesn’t use pins to secure the head in position, and will particularly benefit young children with softer scalps and older folks with fragile bones. Plus, it will look a lot less disturbing to casual observers than current hardware.

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It’s a Trap! Polymer Nanofibers Lure Malignant Brain Cancer Cells into Kill Zone (VIDEO)

It's a Trap! Polymer Nanofibers Lure Malignant Brain Cancer Cells into Kill Zone (VIDEO)

CNS malignancies are typically hard to physically access, often leaving only radiation and chemotherapy as treatment options. This leaves opportunity for the tumor to spread quickly to other parts of the brain, and become completely untreatable. Since tumor cells hijack blood vessels and cellular signaling pathways to allow them to move around the brain, mimicking this mechanism may be a way to lure the eager cancer cells to a single location where they can be easily killed.

Now researchers from Georgia Tech, Children’s Healthcare of Atlanta, and Emory University have developed a system made out of polymer nanofibers that works like a vacuum cleaner to move cells from within a tumor to a cytotoxic hydrogel where they meet their final fate. They tested the system on mice with human glioblastoma and showed that the tumors of mice treated with the nanofibers were significantly smaller than those untreated, or treated with a look-alike smooth fiber not designed to provide therapy. Here’s a Georgia Tech video report with more about the technology:

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Inspire Obstructive Sleep Apnea Therapy Shows Promising Results

Inspire Obstructive Sleep Apnea Therapy Shows Promising Results

Obstructive Sleep Apnea (OSA) affects approximately 12 million people in the U.S. alone. Repeated episodes of apnea due to airway collapse can lead to daytime fatigue and increase a person’s risk for more severe complications, usually cardiac. Existing therapies for OSA include upper airway surgeries, oral devices, and continuous positive airway pressure (CPAP). While CPAP can be particularly effective in patients when used, it can be cumbersome with many patients failing to comply with treatment.

Inspire Medical Systems (Maple Grove, MN), has developed an implantable OSA therapy called Inspire. The system is an implanted upper airway stimulator unit, that looks like a pacemaker, designed to stimulate the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep. During implantation a stimulation electrode is placed on the hypoglossal nerve, a sensing lead is placed between intercostal muscles to sense breathing patterns, and a neurostimulator is implanted just below the clavicle bone. Patients activate the device at night using an external controller.

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