| ANSI ASA S3.25-2009 (Reaffirmed 2014) American National Standard For an Occluded Ear Simulator |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 4-184 |
| Extent | Complete standard |
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| STG | Dental/ENT |
| FDA Tech | Vasant Dasika FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-5365 vasant.dasika@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Ear simulators are intended for earphone response determination, measurement of hearing aid gain and performance, and measurements requiring simulation of the sound transmission characteristics of an external ear. Measurements performed with ear simulators are intended to provide data equivalent to sound pressures at the eardrum generated by sound sources in and around the ear.
This standard gives acoustical performance criteria for a device that provides acoustic impedance and exhibits sound-pressure distributions approximating the median adult human ear between an ear mold and the eardrum. Two specific embodiments whose performance conforms to these criteria are described. Construction details can be found in the annexes.
As a simulation of part of a median adult human ear, the occluded ear simulator is suitable for use in test systems such as manikins, where the complete ear is to be simulated.
Procedures are given for determining that the occluded ear simulator has the specified acoustic performance.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.3300 | Hearing Aid, Air Conduction | Class 1 | ESD |
| There is no relevant guidance developed at this time. |