ANSI s3.221 TEST proccedure

ANSI is a non government agency that writes protocol for testing various items that we use. Every thing from Vacuum cleaners to Hearing Aids. From this the FDA comes up with their rules and regulations. Very complex and while the testing procedures is available for the public the tests by the manufacturer are not. The testing procedure is very technical and not for a non engineer. I tried to see if they test batteries. One battery mfg claims they follow ANSI . I have found no such test but still looking. The Mfg has to submit their tests to the FDA who then checks to see if manufactured items meets the claims. Sort of like Consumer Reports. This takes as long as 10 years to complete. The latest ANSI s3.221 is dated 2008 that the FDA uses The Ansi date is 2003. Wonder why a HA costs so much and so little progress is made? Wonder no more. If you can find a latter date please let me know.

RESound was a one time a US company. Gave up and sold out to the Europeans. Manufacturing in this county is dead.

The latest ANSI S3.22 is 2009. According to the standard, battery current drain is tested using an input signal of 1000 Hz at 65 dB SPL with the gain control set at the reference test position.

The FDA classifies most hearing aids as Class 1 devices, and they’ve exempted almost all of those devices from any type of pre-approval, so manufacturers don’t need to submit anything or wait 10 years. However, they do need to make sure their published specifications are obtained in accordance with the S3.22 test procedures.

thanks for your opinion