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助听器的设计流程:从新概念到上市至少需要10年的时间
#1
Timeline of a hearing aid: from concept to completion
Contributed by Debbie Clason, staff writer, Healthy Hearing
February 24, 2016

[图: hearing-aids-invisible.JPG]Many hearing aids fit almost invisibly in the ear canal. Can you spot the narrow tubing in this picture?

Hearing aids have come a long way from the ear trumpets and large, box-shaped instruments previous generations used to amplify sound in their environment. Today, hearing devices are small enough to fit almost invisibly inside the ear canal while still containing technology so advanced it can distinguish speech from background noise and work compatibly with other technology you use on a daily basis.
How long does it take to make hearing aid? From concept to completion, the process can take more than ten years and involve as many as 500 engineers, consumers, hearing healthcare professionals and retailers – all of whom are focused on creating usable instruments which will enhance quality of life for those who wear them.
1. Research and development
Developing a new, high-end product can involve 200-300 people over a period of three to four years, especially when the manufacturer is introducing a new platform and design but all hearing devices begin as an idea. Many of them come from people just like you – individuals with hearing loss who want to hear well in every listening situation. You tell your hearing healthcare professional what your hearing challenges are and they relay that information back to the hearing aid companies.
Ideas for new hearing aid designs also come from hearing health professionals and retailers, as well as from the latest technology. Once hearing aid companies understand what challenges users are facing, they begin the process of manufacturing a solution.
“Technology is changing all the time. So is the concept of aging,” Mandy Mroz, Digital Director for Healthy Hearing said. “Today’s 65 year-olds don’t consider themselves old. Consumers are very engaged in health and hearing health and have high expectations. That’s a new type of patient for the hearing health professional.”
For example, cell phone technology prompted companies to develop devices which can be controlled with smart phone applications. The goal was to develop user-friendly devices which are easy for the young – and the young at heart – to use on a daily basis.
If the technology doesn’t exist, development is the most time consuming part of the process. For example, one of the biggest complaints current hearing aid users have is the ability to distinguish voices from other background noise. In 2013, researchers at Ohio State University found a way to break sound into units of either speech or noise, then discard the noise. Dr. Eric Healy, a professor of Speech and Hearing Science at OSU who worked on the new technology, said he hopes the technology will be on the market within the next 10 years.
2. Testing
Prototypes with new technology must undergo clinical testing in order to gauge its effectiveness. Companies give their data to the Food and Drug Administration (FDA) in order to secure permission to market it to consumers. That’s because hearing aids are classified as medical devices and must meet strict guidelines.
For example, the FDA recently allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The EarLens Contact Hearing Device (CHD), manufactured by EarLens Corporation of Menlo Park, California, is designed for use by adults with mild to severe sensorineural hearing impairment. The CHD uses the user’s own eardrum as a speaker and enables amplification over a wider range of frequencies.
Another example of new technology currently in the testing phase comes from researchers at the University of Stirling in Scotland who are currently working on a hearing device that will contain a miniaturized camera that can lip-read, process the visual information in real time, and help the user seamlessly switch between audio and visual cues. The researchers expect the new software will enhance communication for users in difficult listening environments, such as noisy restaurants or public transportation venues like airports and train stations.
The concept is one that Gerald Kidd, a professor of speech, language and hearing sciences and specialist in psychoacoustics at Sargent College at Boston University, has been working on since 2011.
A prototype of Kidd’s VGHA device has been in the testing phase since late 2014. He’s hoping hearing aid manufacturers will become interested enough in the device’s potential to make it wearable.
3. Design and manufacturing
Once the technology has been tested and approved by the FDA, engineers must collaborate on design and manufacturing. Although the components themselves may not be expensive, making them fit into attractive, wearable devices can be tricky. Today’s consumer prefers inconspicuous devices which work unobtrusively in the background and won’t interfere with their active lifestyles.
Some manufactures have their own production facilities because the devices require such specific skills and equipment to make that it’s difficult to outsource them. Large production facilities can produce as many as several thousand instruments every week.
4. Education
It’s no secret that hearing aid technology has changed dramatically in the last 50 years. Not long ago, hearing healthcare professionals used screw drivers to manually adjust their patient’s hearing devices. Today, digital hearing aids are accurately programmed from a computer and customized to each patient’s specific hearing loss and lifestyle.
That’s exciting for consumers with hearing loss, but it means hearing healthcare professionals must be constantly learning about new devices are on the market to understand how to fit them for the best possible results.
5. Distribution
Finally, the device is ready to offer to the general public. Many of the big companies, such as OticonStarkey, and Widex, only supply their products to hearing healthcare professionals who directly fit and sell to patients they see in person. That’s because research indicates individuals will have more success wearing their hearing aids if hearing loss has been correctly diagnosed, patients have been carefully counseled and the hearing aid has been properly fit and adjusted.
What does all of this mean? Although making a hearing device is a time-consuming process, the consumer can be assured the hearing devices they receive from qualified, licensed hearing healthcare professionals have been thoroughly researched, manufactured, tested and FDA approved. Although the process may take as many as ten years, the successful result it provides for those with hearing loss is worth the wait. 







Orignal article from:

https://www.healthyhearing.com/report/52...completion

Debbie Clason, staff writer, Healthy Hearing

[图: about-debbie-clason.jpg]Debbie Clason holds a master's degree from Indiana University. Her impressive client list includes financial institutions, real estate developers, physicians, pharmacists and nonprofit organizations. Read more about Debbie.
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