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KMID : 1142220130080010103
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.103 ~ p.110
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A Study on the International Harmonization of Hearing Aids
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Cho Eun-Jeong
Lee Jae-Won
Yeon Hong-Won
Kim San
Lee Jong-Chul
Kang Shin-Jung
Kim Hyeog-Ju
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Abstract
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Sufficient levels of safety and effectiveness should be ensured for hearing aid medical devices because body functions are superseded by them. However, standards for the most popular hearing aid, the air-conduction type, have not been revised since its establishment, so the effectiveness in its permission process and the safety have been deteriorated, not satisfying the relevant international standards. Such inadequate conditions may be obstructive when advancing into foreign markets. This study is purposed for securing the safety and effectiveness of the hearing aid medical devices by proposing standards of the air-conduction type hearing aid in the international levels. Pertinent test items and standards were derived from investigations and analyses of Korean and overseas standards applicable in the purpose. Therefore, this study proposes new and revised reference standards by adopting more advanced standards from the revised version of the 2003 ANSI Standard. This study will improve the quality management of the hearing aid medical devices to the international level, contributing to revitalization of the Korean medical device industry.
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KEYWORD
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Hearing aid medical device, reference standard, safety, effectiveness
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