As of July 12, 1999, the ANSI S3.22-1996 standard has been published by the FDA. The latest version of the ANSI S3.22 standard entitled, "Specification of Hearing Aid Characteristics" has made it into FDA regulations. The period of comment which normally follows publication in the Federal Registry has been omitted which means manufacturers have six months to conform to the new revision.
A Short History of the Standard
The ANSI S3.22 standard was first created in 1976 at the request of the FDA who was given the authority to regulate hearing aids as a medical device. When the standard is completed and published, it becomes a voluntary procedure to follow unless a regulatory agent such as the FDA adopts the standard and includes it in its regulations. Such was the case for the S3.22.
Normally, ANSI standards are revised, deleted, or reaffirmed every five years in order to keep up with changing technologies and procedures. The S3.22 was revised in 1982 and again in 1987. Both times the FDA adopted the changes into its regulations. However, the latest revision of the standard has been a long and drawn out process, due to long discussions and subsequent experimentation with new telecoil testing methods and the decision to include tests in the appendices that were previously included on the now-obsolete ANSI S3.3 standard.
The new revision of the standard has been published in the Federal Registry. In the past, there was a period of 90 days of comment following publication before the standard would be included in regulations. The latest information indicates, however, that this period will be omitted, forcing manufacturers to conform to the latest revision within six months.
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Changes in the ANSI S3.22 Standard
1987
"Saturation Sound Pressure Level with a 90-dB input" (SSPL90)
1996
"Output SPL with a 90-dB input" (OSPL90)
1987
AGC aids measured using full-on gain
1996
AGC aids measured using reduced reference-test position
1987
AGC aids measured using attack and release levels 55-80-55
1996
AGC aids measured using attack and release levels 55-90-55
1987
AGC aids measured using attack and release levels 55-90-55
1996
Attack level for AGC aids determined when a steady state within 3 dB is attained
1987
Release level for AGC aids determined when a steady state within 2 dB is attained
1996
Release level for AGC aids determined when a steady state within 4 dB is attained
1987
I/O curve for AGC aids measured at 2000 Hz with input levels from 50 to 90 dB in 10 dB steps
1996
I/O curves for AGC aids measured with a choice of 250, 500, 1000, 2000, and 4000 Hz with input levels from 50 to 90 dB in 5 dB steps
1987
Telecoil measured with full-on gain
1996
Telecoil measured with reduced reference-test gain
1987
Telecoil measured with a weak magnetic field
1996
Telecoil measured with a 10 dB stronger magnetic field created with a "Telecoil Magnetic Field Simulator" (TMFS)
1987
Telecoil measured with a frequency of 1000 Hz
1996
Telecoil measured with a range of frequencies between 200 and 5000 Hz. The resulting curve is called the "Sound Pressure Level for an Inductive Telephone Simulator" (SPLITS) curve.
1996
Additional measurement: "High-Frequency Average" of the SPLITS curve (HFA-SPLITS) is the average SPLITS value at 1000, 1600, and 2500 Hz. You can also take the "Special Purpose Average" (SPA-SPLITS) for those aids with specified frequencies
1996
Additional measurement: Simulated Telephone Sensitivity (STS):
HFA-SPLITS - reference-test gain + 60 dB
or
SPA-SPLITS - reference-test gain + 60 dB
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It seems that the 1996 revision will be the way that manufacturers test hearing aids. Make sure that you, your staff, and your equipment are prepared.
*Frye Electronics has the ANSI 96 automatic test sequence available for the FONIX 6500-CX. Existing units can be upgraded.
*Information contained in this release was submitted by Frye Electronics
*Refer to the October 1996 issue of the Hearing Journal and the March/April 1999 issue of Audiology Today for further information on the ANSI S3.22-1996 Standard
The ANSI S3.22-1996 Standard
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