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Hearing loss has now become a major public health problem facing the world
.
The latest "World Hearing Report" released by the World Health Organization shows that there are currently about one-fifth of the world's hearing loss patients, the number of which exceeds 1.
As an implantable hearing solution, cochlear implants will accompany the implanter for a long time once implanted
.
Therefore, the quality of cochlear implant products is very important, and reliability is an important indicator of product quality
Recently, Cochlear Co.
, Ltd.
(Cochlear for short), a leading manufacturer in the global cochlear implant industry, released the latest issue of the "2020 Reliability Report", which details the reliability of cochlear implants and sound processors.
Interpretation, the report is of great significance for the popularization of implanters and the promotion of the entire industry in a more standardized direction
.
Authoritative and objective, Cochlear continues to demonstrate high product reliability
The reliability report released by Cochlear follows the industry's most authoritative and strict international statistical standard for cochlear implant reliability: implants use "European Consensus and International Classification Standards" (referred to as European standards), and sound processors use ANSI/AAMI CI86 (Referred to as American Standard)
.
Since the release of European standards in 2005, Cochlear has continuously released implant reliability reports every year and published reliability data for each generation of products
.
In 2017, the U.
How to judge the reliability? High cumulative intact rate and low failure return rate
The reliability reports of cochlear implants and sound processors follow the following criteria
.
(1) Cochlear implant
As far as cochlear implants are concerned, European standards use Cumulative Integrity (CSP) percentages to express product reliability - the higher the Cumulative Integrity percentage, the higher the product reliability
.
The so-called CSP refers to the percentage of implants that are still working normally from implantation to the statistical deadline
Cochlear’s latest reliability report for 2020 shows the CSP data of two series of cochlear implants: CI500 slim series implants 99.
79% in 7 years; CI400 classic series implants 99% in 16 years
.
Among them, CI500 slim series implants have become a benchmark in the industry by virtue of their 7-year 99.
In addition to paying attention to the data itself, the interpretation of CSP must also consider its calculation conditions
.
The first is the number of products used - the larger the number, the more reliable its percentage reflects the overall strength of the company and product
In addition, the length of time is also an important reference dimension-the longer the time to market, the longer it takes to prove that the product has undergone quality testing.
Take the Cochlear CI400 classic series as an example.
Since its listing in 2005, it has served people with hearing loss for 16 years.
After a while, the cumulative intact rate can still reach 99.
0%
.
Among the more than 200,000 implants of the CI400 series, more than 120,000 implants in children, which also confirms that the series has excellent performance in terms of long-term stability and reliability
(2) Sound processor
According to American standards, the indicator for measuring the reliability of sound processors is the failed sound processor return rate (FCRR), which refers to the number of failed sound processors returned for repair within a month and the cumulative sales of the same processors at the end of the month.
Percentage
.
The lower the FCRR, the higher the reliability
Affected by seasonality and other factors, the average value of multiple months' data can more accurately reflect the true situation of product reliability than single-month data
.
Therefore, American standards require manufacturers to provide monthly FCRR data for 24 consecutive months
.
Currently, Cochlear is the only company in the industry that strictly complies with American standards and provides complete data required for 24 months
.
From the data point of view, the average monthly FCRR of Cochlear's sound processor products for 24 consecutive months is: Nucleus 6 sound processor 0.
8%, and the return rate of failed sound processors is lower than the industry average.
In other words, it has high reliability.
Sex
.
The high cumulative integrity rate of cochlear implants and the low failure return rate of the sound processor are objective, fair and direct manifestations of the high reliability of Cochlear products
.
Through these data, it can be seen that with the continuous innovation and upgrading of Cochlear products, product reliability has been further improved
.
It is precisely with the unremitting pursuit of high reliability and high quality of products that Cochlear has brought long-term confidence to the majority of users.
This is also the reason why Cochlear products are so popular and popular all over the world
.
In the future, Cochlear will continue to pursue excellent product quality as the goal, and bring long-term benefit hearing solutions to users
.
Focus on research and development, quality assurance, Cochlear brings long-term confidence to users
Innovation is endless, and reform is endless
.
While ensuring high-quality and high-reliability products, Cochlear attaches great importance to R&D and innovation.
It maintains close cooperation with more than 100 research institutions around the world, and continuously promotes the rapid development of the hearing industry with a variety of innovative solutions for the benefit of People with hearing loss will return to the world of sound and enjoy a better life
.
In order to better meet the needs of the Chinese market, Cochlear invested in the construction of a hearing industry base in Chengdu in 2018
.
And focus on cultivating Chinese cochlear implant professionals, introduce internationally advanced clinical assessment, treatment methods, language training and rehabilitation concepts and tools, and spare no effort to promote academic communication at home and abroad
.