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On Tuesday March 23, 2010, the president signed into law H.R. 3590, the Patient Protection and Affordable Care Act. During final negotiations over the previous weekend, the FDA Class I medical device tax exemption was dropped; however, a specific hearing aid exemption that was included in the legislation last Thursday was retained. This will exempt hearing aids from the medical device tax that will be imposed on almost all other devices not sold at “retail.”

Below is an excerpt from the over 2400 page law:

Subchapter E - Medical Devices
SEC. 4191. MEDICAL DEVICES.

IN GENERAL. - There is hereby imposed on the sale of any taxable medical device by the manufacturer, producer, or importer a tax equal to 2.9 percent of the price for which so sold.

TAXABLE MEDICAL DEVICE. - For purposes of this section - IN GENERAL. - The term 'taxable medical device' means any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) intended for humans.

(2) EXEMPTIONS. - Such term shall not include - (A) devices classified in class I under section 513 of such Act, eyeglasses, contact lenses, hearing aids, and any other medical device determined by the Secretary to be of a type which is generally purchased by the general public at retail for "individual use." and by inserting after the item relating to subchapter D in the table of subchapters for such chapter the following new item...

...It's a hard message to convey. Hearing loss, which accumulates slowly over a lifetime, is neither painful nor disfiguring, so it goes unnoticed. Stephen Glasser, an audiologist in Great Neck, NY, says the stigma attached to hearing aids - often considered a sign of age or weakness -seems to carry over to hearing protection... For the full article go to http://www.nytimes.com/2010/03/02/health/02baby.html

February 2, 2009 - Plymouth, Minnesota - Today represents a milestone for the uHear application as it surpasses the quarter of a million download mark. uHear, a self-administered hearing screening test for the iPhone and iPod touch, has seen a continuous position on iTunes top 10 medical downloads since its release. There are approximately 36 million Americans afflicted by hearing loss and it is projected that by the year 2015 the number of Americans suffering from hearing loss will increase between 20 to 25 percent. Consumers are becoming more aware and seeking discreet, free testing options.

To date more than 300,000 people have taken advantage of uHear, the most widely distributed hearing screening test ever. "We know that people downloading uHear typically share the application with two to four others," commented Cameron Hay, President and CEO of Unitron worldwide. "This makes it possible that over a million people have tested their hearing and taken the first step towards healthy hearing."

In September, Apple announced that their iTunes selection exceeded over 140,000 applications. Though a handful of applications have exceeded the millions of download mark (Facebook, Myspace), the majority average only 3000, while uHear is 300,000. "It’s great to see the response to uHear when compared to these numbers. It emphasizes the concern people may have about hearing loss, their own or family members," notes Hay. The uHear application continues to be amongst the top 10 health downloads having been 1st or 2nd place on iTunes in over seven countries. "With uHear’s worldwide success and continuous downloads, we are now giving even more people across the world an easy way to screen their own hearing performance. Unitron is committed to increasing hearing awareness and improving the lives of people living with hearing loss," says Hays.

The application created by Unitron is available worldwide, in both English and French, can be downloaded free of charge through Apple iTunes at: http://itunes.com/apps/uhear.

Westminster, CO - The National Hearing Conservation Association announces that an Educator Training Workshop will be presented by Dangerous Decibels from February 28 to March 1, 2010 at the Rosen Plaza Hotel in Orlando, Florida.

Dangerous Decibels is a public health campaign designed to reduce the incidence and prevalence of noise-induced hearing loss (NIHL) and tinnitus by changing knowledge, attitudes, and behaviors of school-aged children about exposure to loud sounds and use of hearing protection strategies.

"Health experts tell us that in order to bring about change in knowledge, attitudes, and behaviors, we must reach children with the message early and often," said Linda Howarth, Dangerous Decibels Program Coordinator. "If we can educate children about these issues early in life, they will be more likely to protect their hearing later when they are exposed to hazardous sounds at work and at play."

The Dangerous Decibels classroom program has been rigorously evaluated and found to be highly effective in changing knowledge, attitudes, and intended behaviors in school age children. The Educator Training Workshop fully equips and prepares individuals by providing the key information, teaching materials and supplies, practical experience and important logistical insights to guarantee a successful program delivery. K-12 educators frequently comment that the program content is easily integrated into math and science educational curricula.

This two-day Educator Training Workshop will be presented by several hearing conservation, health communication and educational outreach experts, including:

- William (Billy) Hal Martin, PhD. - Oregon Hearing Research Center / Oregon Health & Science University

- Susan Griest, MPH - Oregon Hearing Research Center / Oregon Health & Science University

- Deanna Meinke, PhD. - University of Northern Colorado

- Linda C. Howarth - Oregon Hearing Research Center / Oregon Health & Science University

The workshop will include background information on hearing, anatomy, physics of sound, children and noise, etc. Instruction includes classroom management, hands-on activities, and an opportunity to deliver the program to instructors for critique and feedback. Participants will receive an educator kit with graphics, simulations, supplies, a script and a sound level meter needed to present the classroom program.

About the National Hearing Conservation Association [NHCA]

The mission of the National Hearing Conservation Association is to prevent hearing loss due to noise and other environmental factors in all sectors of society. NHCA provides networking, resources and professional development opportunities to improve skills, practices and services for over 600 members. NHCA's membership includes audiologists, researchers, students, industrial hygienists, educators, professional service organizations, safety professionals, medical professionals, engineers, audio professionals and others who have dedicated their work to the advancement of hearing loss prevention. For more information about the National Hearing Conservation Association, visit us online at www.hearingconservation.org.

About Dangerous Decibels

The Dangerous Decibels project is a public health campaign designed to reduce the incidence and prevalence of Noise Induced Hearing Loss (NIHL) and tinnitus (ringing in the ear) by changing knowledge, attitudes, and behaviors of school-aged children. The project is built upon an innovative collaboration between basic science researchers, museum educators, civic leaders, Oregon and Southwest Washington schools and volunteers in a unique public/private partnership. Partners are the Oregon Hearing Research Center at the Oregon Health & Science University (OHSU) and the Oregon Museum of Science and Industry (OMSI), in affiliation with the Portland VA National Center for Rehabilitative Auditory Research, and the American Tinnitus Association. Learn more about Dangerous Decibels at www.dangerousdecibels.org.

11 December 2009 - The first year to two years of life is a critical time for hearing impaired children and their language development. Whilst young babies with hearing difficulties can now be fitted with cochlear implants, accurately assessing the effectiveness of the implants does present challenges prior to their development of language skills.

However, a major breakthrough may now be on the horizon, thanks to a bourgeoning collaboration of the world's leading experts in hearing, engineering and cognitive development.

The international team, comprising experts from Macquarie University, the Kanazawa Institute of Technology (KIT), Cochlear Limited, National Acoustic Laboratories, and the CSIRO, met at Macquarie University this week to discuss plans for a world-first brain imaging device that will allow scientists to test the auditory cortex of hearing impaired babies fitted with cochlear implants.

Such a device would improve hearing specialists' ability to accurately assess the effectiveness of a baby's implant and then make adjustments if needed - even before the child can speak - to give them the best hearing possible and assist with language development.

"Ultimately the aim is to be able to better adjust the implants while the children are still very young - only babies - so their cognitive development will proceed normally from a very early age," said Professor Stephen Crain, from Macquarie University's Centre for Cognitive Science.

"At the moment accurately measuring how well a cochlear implant is working in a very young child is difficult. This is because babies and toddlers are unable to communicate effectively using language, so they can't describe to scientists what they are hearing or how loud and clear something may sound to them," he said.

"If we can achieve early implantation and then adjust the implant to the child's brain, we believe we can make implants more effective."

Crain and his team devised the first brain imaging system in the world that can measure the magnetic fields generated by a child's brain during cognitive processing. Called a MEG system - short for magnetoencephalography - the device was developed by scientists from Japan's Kanazawa Institute of Technology (KIT) and is now housed at Macquarie University's cognitive science laboratory.

"It is probably possible to construct a map of the auditory cortex of a child with normal hearing using our existing child MEG system, but if we tried to test a child with a cochlear implant, the system would be overwhelmed by the powerful signals emitted by its electronic components," Crain said.

"In order to successfully develop a system which can be used with these children, we need to invent a completely new way of shielding the MEG sensors from the powerful magnetic waves generated by a cochlear implant."

If such a device can be developed, Crain and his team will establish ‘normal' cognitive function by using a control group of children without hearing impairment, before working with young children fitted with cochlear implants.

Work is expected to commence on a prototype of the new system early next year.

Taken from www.mq.edu.au/.