• ASTM F2504-05

ASTM F2504-05

Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

ASTM International, 11/01/2005

Publisher: ASTM

File Format: PDF

$29.00$58.00


Published:01/11/2005

Pages:6

File Size:1 file , 190 KB

Note:This product is unavailable in Russia, Ukraine, Belarus

1.1 This practice defines means for describing system performance (ex vivo) and, in particular, system output of an implantable middle ear hearing device (IMEHD) by measuring a physical quantity that is relevant to the insertion gain and output level of the IMEHD when implanted in the patient.

1.2 This practice is similar to headphone calibration on an artificial ear in which the sound pressure level (in decibel sound pressure level (SPL)) measured in the artificial ear can be converted to patient hearing level (in decibel hearing level (HL)) using a known transfer function, as defined by ANSI 3.7. These measurements can then be used to predict system parameters relevant for patient benefit such as functional gain, maximum output, and variability. Measurements defined in this practice should be useful for patients, clinicians, manufacturers, investigators, and regulatory agencies in making comparative evaluations of IMEHDs.

1.3 The values given in SI units are to be considered the standard.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

More ASTM standard pdf

ASTM D1510-01

ASTM D1510-01

Standard Test Method for Carbon Black - ;Iodine Adsorption Number

$30.00 $60.00

ASTM C71-00a

ASTM C71-00a

Standard Terminology Relating to Refractories

$30.00 $60.00

ASTM A494/A494M-03a

ASTM A494/A494M-03a

Standard Specification for Castings, Nickel and Nickel Alloy

$30.00 $60.00

ASTM A955/A955M-03b

ASTM A955/A955M-03b

Standard Specification for Deformed and Plain Stainless Steel Bars for Concrete Reinforcement

$30.00 $60.00