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ASTM F 2504 : 2005 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
Available format(s)

Hardcopy , PDF

Superseded date

10-14-2022

Language(s)

English

Published date

04-07-2014

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Describes 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.

1.1This 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.

1.2This 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.

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

1.4This 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.

Committee
F 04
DocumentType
Standard Practice
Pages
6
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ANSI/ASA S3.7 : 2016 METHOD FOR MEASUREMENT AND CALIBRATION OF EARPHONES
ANSI S3.6 : 2010 SPECIFICATION FOR AUDIOMETERS
ANSI/ASA S3.22:2014 SPECIFICATION OF HEARING AID CHARACTERISTICS

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