A Critical Appraisal of Nonconformity of New Hearing Aids with American National Standards Institute Standards

CANADIAN JOURNAL OF SPEECH-LANGUAGE PATHOLOGY AND AUDIOLOGY(2022)

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摘要
Some studies have found an alarming rate of hearing aids' nonconformity with American National Standards Institute standards, but research in this area is limited. This study reports a comprehensive assessment of the compliance rate of hearing aids of various brands and styles. The Audioscan Verifit-1 analyzer was used to examine the compliance of 62 new hearing aids with the S3.22-2014 standard of the American National Standards Institute. Audioscan Verifit-2 and Aurical test systems were also used to determine the potential influence of hearing aid test systems on the compliance rate. With the Verifit-1 test system, most hearing aids (96.8%) were found to be out of specification for the equivalent input noise measure. Compared to equivalent input noise, the compliance rates for output sound pressure level, high-frequency average at 50 dB, and total harmonic distortion were higher and did not differ between brands and styles. The type of analyzer had a considerable impact on the measured equivalent input noise compliance rate: Compared to the Verifit-1, the Verifit-2 and Aurical test systems indicated a higher compliance rate (> 90% versus similar to 5%). However, there were no differences in compliance rates across the analyzers for the rest of the tests. This study reveals that hearing aids mostly comply with the standard. There is a need to establish clinically reproducible and easily accessible testing protocols for the quality control of hearing aids at various stages of use.
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关键词
ANSI STANDARDS,ELECTROACOUSTIC MEASUREMENTS,HEARING AIDS,QUALITY CONTROL
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