Stretch It Out – Maintaining Your Voice’s Biggest Support System

Whether you are a professional athlete or a professional speaker, properly warming up your muscles is essential to peak performance.

If you are a track star, you would never start a race without stretching out your hamstrings, and warming up your quads – so why wouldn’t you take the same care for your voice if that is your money-making muscle?

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IMTHERA MEDICAL, INC. RECEIVES FDA APPROVAL FOR PIVOTAL STUDY FOR OBSTRUCTIVE SLEEP APNEA DEVICE

Via ImThera Medical:

November 10, 2014

ImThera Medical, Inc. Receives FDA Approval for Pivotal Study for Obstructive Sleep Apnea Device

THN3 Study Will Expand the Clinical Evidence for this Novel Neurostimulation Therapy for Moderate to Severe Obstructive Sleep Apnea

 

SAN DIEGO, CA November 10, 2014

ImThera Medical, Inc., a privately held global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its THN3 Clinical Study. The THN3 Study will evaluate the safety and effectiveness of the aura6000® System for moderate to severe obstructive sleep apnea (OSA) in individuals who are unable to comply or unwilling to try PAP therapy or other OSA treatments. Data from this pivotal clinical study will be used to support a Pre-Market Approval (PMA) application for the aura6000 System.

“This is the most exciting innovation for the treatment of sleep apnea since CPAP,” said Michael Friedman, M.D., Professor of Otolaryngology and director of Chicago Sleep Center at Rush University Medical Center, Chicago IL and a study investigator. “I have had experience implanting the device during the earlier THN2 study. It is an easy and safe procedure to perform.”

Sponsored by ImThera Medical, the THN3 Study (Targeted Hypoglossal Neurostimulation Study #3) is a randomized, controlled, prospective, multi-center clinical trial. It is being conducted at leading medical centers in the United States and Europe. For more information on the THN3 Study visit http://www.THNStudy.com.

“This is a substantial milestone in the development of this technology,” said Alan Schwartz, M.D. Professor of Medicine and Medical Director, Johns Hopkins Sleep Disorders Center, Baltimore MD, principal investigator of the THN3 study, “We have seen very encouraging results from the earlier studies showing that most patients treated with the aura6000 System experienced significant improvements in their sleep apnea.”

“Millions of Americans are waiting for a solution for their obstructive sleep apnea,” said Marcelo Lima, President and CEO at ImThera Medical, “The approval of this study brings us one critical step closer to being able to make this novel device available to those patients.”

About ImThera Medical and the aura6000 System

The aura6000 System is based on ImThera’s proprietary THN Sleep Therapy® technology. THN Sleep Therapy delivers neurostimulation to the hypoglossal nerve increasing muscle tone of multiple tongue muscles and preventing the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to address nighttime upper airway blockage, permitting normal and restful sleep for OSA patients. “Essentially, the system keeps the tongue in an awake position while the patient sleeps,” explains Dr. Michael Friedman.

The system consists of two implantable components, a small rechargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck. The electrodes deliver mild pulses to the hypoglossal nerve, stimulating various muscles and thereby increasing upper airway flow during sleep.

In November 2012, the aura6000 System was awarded the Golden Electrode Award for Best New Product. The aura6000 System has received the CE Mark, and is commercially available in select markets outside the United States. Within the United States it is only available to participants in this study.

About ImThera Medical, Inc.

San Diego-based ImThera Medical is a privately held company and a global leader in neurostimulation for the treatment of Obstructive Sleep Apnea (OSA). For more information, visit http://www.ImTheraMedical.com.

About OSA

OSA is characterized by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than one million Americans are diagnosed annually with OSA. As many as 28 million Americans may suffer from OSA and only approximately 25 percent of this population is receiving treatment today.

While OSA is readily treated with continuous positive airway pressure therapy (CPAP), studies show that CPAP is a cumbersome treatment, and between 30-60% percent of patients cannot or will not comply with CPAP.

For more information on the THN3 Study visit http://www.THNStudy.com.

CAUTION: Investigational device. Limited by United States law to investigational use.

 

ImThera, aura6000, and THN Sleep Therapy are registered trademarks, and THN is a trademark of ImThera Medical, Inc.

© ImThera Medical, Inc. 2014 All rights reserved.

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From the Hearing Journal – New hearing conservation initiatives: Small steps with great potential

professional-voice-blog-colorad-voice-clinic-hearing-study-decibel-effects-hearing loss-concert-sound-Dr. Dave Opperman-study-research-noice-ENT doctors in colorado-ENT doctors in Denver-specialist-ear-nose-throat-otolaryngology-health-hospitalSara Bloom of The Hearing Journal discusses new hearing conservation initiatives, including research on the effects of noise levels on children and concertgoers.

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Trim the Fat – Your Waistline & Voice Will Thank You

If you suffer from heartburn, acid reflux, or GERD, high fat foods can be your worst enemy.

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Five Things You Can Do to Combat High Altitude’s Harmful Effects on Your Voice

Even if you live in high altitude environments, your body is not immune to the harsh conditions of the mountain air. Artists, speakers, or professionals who make frequent trips to climates like the Rocky Mountains have experienced first hand the drying effects of high altitude. The air is thinner, the humidity is low to non-existent, and the lack of oxygen can naturally cause you to develop some harmful habits that leave your throat, nose, and mouth feeling like the Arizona desert – not ideal at all for professionals speakers or singers.

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Ten of the Easiest Ways to Maintain Your Professional Voice

THE PRO VOICE BLOG

Just like the rest of your muscles, your voice requires healthy habits to stay in top shape. Especially if you require the use of your voice for your profession, simple things like drinking water and breathing properly can help keep you off costly and annoying vocal rest…or more severe problems with your valuable pipes.

Here are ten of the easiest ways you can keep your vocals in peak condition every day:

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The Colorado Voice Clinic

Cosmetic Surgery & ENT – Consult Your ENT Specialist For Certain Procedures

ENT doctors don’t only specialize in your ear, nose, and throat problems. Did you ever consider consulting with your Otolaryngologist about Botox?
The Colorado Voice Clinic performs helpful cosmetic procedures that can improve your image and increase confidence. As a professional actor, musician, or speaker you know it’s all about having the complete package. If you’re working on making your voice the best it can be why not improve your appearance as well?

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