求助助听器FDA文献资料标准大全

猛象登山巅

正在准备注册美国FDA的助听器，好多资料要准备，
其中这些资料，哪位大佬有，望指条明路，十分感谢

Recognized Consensus Standards：
4-160 ASA ANSI S3.1-1999 (Reaffirmed 2023)
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms

4-162 ASA ANSI S3.4-2007 (Reaffirmed 2020)
American National Standard Procedure for the Computation of Loudness of Steady Sounds

4-163 ASA ANSI S3.5-1997 (Reaffirmed 2020)
American National Standard Methods for Calculation of the Speech Intelligibility Index

4-167 ASA ANSI S3.21-2004 (Reaffirmed 2023)
American National Standard Methods for Manual Pure-Tone Threshold Audiometry

4-171 ASA ANSI S3.37-1987 (Reaffirmed 2020)
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids

4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006)
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment

4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020)
American National Standard For Rating Noise with Respect to Speech Interference

4-184 ASA ANSI S3.25-2009 (Reaffirmed 2024)
American National Standard For an Occluded Ear Simulator

4-190 ANSI ASA S3.35-2010 (Reaffirmed 2020)
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions

4-204 ASA ANSI S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020)
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)

4-211 ANSI ASA S3.46-2013 (Reaffirmed 2023)
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids

4-217 ANSI ASA S3.36-2012 (Reaffirmed 2022)
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements

4-220 ANSI ASA S3.22-2014 (Reaffirmed 2020)
American National Standard Specification of Hearing Aid Characteristics

4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020)
American National Standard Bioacoustical Terminology

4-260 ANSI ASA S12.2-2019 (Reaffirmed 2023)
American National Standard for Criteria for Evaluating Room Noise

4-274 ASA ANSI S3.2-2020
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems

4-277 ANSI IEEE C63.19-2019
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids

4-312 ANSI ASA S3.35-2021
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions

十z7wa6686

没找到免费下载的，不过道客巴巴上有可以浏览

陈钱罐

博主做的是哪一类助听器呀？我看FDA有些助听器是可以分到做I类备案，或者是II类豁免510k的。

猛象登山巅

陈钱罐 发表于 2025-7-16 10:49
博主做的是哪一类助听器呀？我看FDA有些助听器是可以分到做I类备案，或者是II类豁免510k的。

是的，这两个都有，你之前有做过成功案例？

陈钱罐

猛象登山巅 发表于 2025-7-17 08:17
是的，这两个都有，你之前有做过成功案例？

没有呢，公司现在有一个助听器的FDA项目，已经开始着手前面阶段的资料准备了