Investigation And Countermeasure Research On Testing Ability Of Quality Inspection Organization Of Hearing Aids In China

There are about 85.02 million people with disabilities in China,including 20.54 million hearing loss,accounting for 24.16%;as of the end of 2014,the national 60 years old and above the elderly 212.42 million,15.5% of the total population,of which 65 years and over population 137.55 million 10.1% of the population,with the increase in the number of hearing disabled and aging in China continue to increase the demand for hearing aids more and more,the market types of hearing aids are endless,from the traditional hearing aids,cochlear implant,vibration Alarm clock wait until the current BAHA,Vibrant Sound-bridge,more and more products are used or even implanted in the body,the quality of the body is authorized by the state with a third party impartial authority of the testing institutions,the standardization of hearing aids production and Quality has important significance.In this paper,through the in-depth study and a comprehensive analysis of the national testing related to the development of hearing aids institutions to understand the basic situation,to find the existing problems,and then on the future development of hearing aids detection agencies to make recommendations for a more rational use of testing institutions,More fundamental to ensure that the user’s personal safety,to provide information based.Objective:In this paper,21 hearing aids detection agencies as the object of study,to detect the ability of the national hearing aids detection institutions of the basic situation and detection capabilities,to master our current stage of hearing aids quality inspection agencies industry status and testing system;to understand the use of hearing aids detection equipment on the international standards,national standards,enterprisestandards,the use of corporate standards to explore and improve the standard structure of various types of hearing aids;found in our current stage of hearing aids detection of existing problems,Further analysis,the future of China’s hearing aids detection agencies to develop and improve the detection system to provide constructive comments.Methods:In this paper,the use of census methods to 21 countries with third-party status of hearing aids detection institutions for the study.The use of China Assistive Devices and Technology Centre for Persons with Disabilities and National Supervision &Testing Centre of Quality for Rehabilitation Instrument unified design of the "hearing aids quality testing organizations detection capacity questionnaire",through the questionnaire survey,telephone counseling,field visits,etc.,around the institutional affiliation,Personnel structure,equipment use,testing ability,recognized qualification,national international standards and other aspects of the survey,the use of Excel 2007 software input data,counting data usage and composition ratio,the use of descriptive statistical analysis method for statistical analysis.Results:1.A total of 3042 people were surveyed in the study of 21 hearing aids testing institutions.Among them,north China and eastern Region a total of 11,accounted for52.4%,the total number of 1767 people,accounted for 58.1%,the northeast and northwest region altogether 4,accounted for 19%,the total number of 337 people,accounted for 11.1% of the total number,there are obvious regional differences,the northeast,northwest less developed areas of the,small size,fewer personnel,21 institutions affiliated to the drug supervision system of 18,accounted for 85.7%,the total number of 2867 people,accounted for 94.2% of the total number of other systems(civil,the Federation,Ministry of Services)3,accounting for 14.3%,the total number of 175 people,accounted for 5.8% of the total number of institutions were awarded " The National Drug Administration of medical equipment quality Supervision and Inspection Center " 7,accounted for 33.3%,the total number of 1745 people,accounted for 57.4% of the total number of other institutions 14,accounting for 66.7%,the total number of 1297,accounting for 42.6%.2.All hearing aids testing institutions personnel,listening professional and technical personnel 56 people,accounting for 0.2%,the average person of all testing agencies trained 1.7 times per year.3.The state-level medical device Testing Center is more capable than the non-state-level medical device detection organization,and the inspection organization of the drug supervision system is more capable than other system’s detection organization.Mainly reflected in the total number of personnel,education,testing qualification certification,testing product capabilities,sponsoring periodicals,standardization committee,professional number and title level.4.The inspection mechanism of the drug supervision system can detect 2.1 kinds of hearing aids,and the average detection mechanism of other systems can detect 1kinds of devices.Drug supervision System 18 testing institutions,the total number of recognized international standards 16,an average of about 1,recognized national standards of 64,an average of 4 per home,other systems recognized international standards of 0,recognized the national standard of the average 2.5.The drug monitoring system and other system testing agencies detect more hearing aids types are air conduction hearing aids,followed by bone conduction hearing aids,cochlear implants and other;National testing agencies mainly detect air conduction hearing aids and cochlear implants,and other mechanisms are mainly air conduction hearing aids.Conclusions:1.Hearing aids testing institutions in the number of personnel,professional and technical capacity of personnel,geographical location was uneven.2.The professional technical ability of the testing personnel needs to be strengthened,the number of personnel training is less,and the training mechanism needs further improvement.3.The testing institutions differ significantly in their aptitude,number ofproducts tested,and the quantity of the secretariat of the standard Technical Committee.Detection of the type of hearing aids single,the introduction of the implementation of international standards was less,standard development lag to international level.Countermeasures and recommendations:1.The reasonable planning of the national testing organizations,optimize the efficient allocation of resources.2.To strengthen professional training,extensive technical exchanges.3.To speed up the introduction of advanced aids and domestic AIDS research to meet domestic demand.4.To promote the standard capacity to improve and improve the standardization system.