Do Modern Hearing Aids Meet ANSI Standards?

Abstract

Background: The American National Standards Institute (ANSI) provides standards used to govern standardization of all hearing aids. If hearing aids do not meet specifications, there are potential negative implications for hearing aid users, professionals, and the industry. Recent literature has not investigated the proportion of new hearing aids in compliance with the ANSI specifications for quality control standards when they arrive in the clinic before dispensing.

Purpose: The aims of this study were to determine the percentage of new hearing aids compliant with the relevant ANSI standard and to report trends in electroacoustic analysis data.

Research design: New hearing aids were evaluated for quality control via the ANSI S3.22-2009 standard. In addition, quality control of directional processing was also assessed.

Study sample: Seventy-three behind-the-ear hearing aids from four major manufacturers, that were purchased for clinical patients were evaluated before dispensing.

Data collection and analysis: Audioscan Verifit (version 3.1) hearing instrument fitting system was used to complete electroacoustic analysis and directional processing evaluation of the hearing aids. Frye's Fonix 8000 test box system (Fonix 8000) was also used to cross-check equivalent input noise (EIN) measurements. These measurements were then analyzed for trends across brands and specifications.

Results: All of the hearing aids evaluated were found to be out of specification for at least one measure. EIN and attack and release times were the measures most frequently out of specification. EIN was found to be affected by test box isolation for two of the four brands tested. Systematic discrepancies accounted for ∼93% of the noncompliance issues, while unsystematic quality control issues accounted for the remaining 7%.

Conclusions: The high number of systematic discrepancies between the data collected and the specifications published by the manufacturers suggests there are clear issues related to the specific protocols used for quality control testing. These issues present a significant barrier for hearing aid dispensers when attempting to accurately determine if a hearing aid is functioning appropriately. The significant number of unsystematic discrepancies supports the continued importance of quality control measures of new and repaired hearing aids to ensure that the device is functioning properly before it is dispensed and to avoid future negative implications of fitting a faulty device.