ASTM F2504 - 05(2014) - Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

ASTM F2504 - 05(2014)

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

Status : Current   Published : January 2014

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HARDCOPY



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.

1.4  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.




Standard NumberASTM F2504 - 05(2014)
TitleStandard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
StatusCurrent
Publication Date03 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Electromechanical hearing, Hearing implant, IHD, Implantable hearing aid, Implantable middle ear hearing device, IMEHD, Laser interferometry, Middle ear, Middle ear implant, System output, System performance, Temporal bone, Transfer function, Vibrational transducer, Vibratory implant
ICS11.180.15
PublisherASTM
FormatA4
DeliveryYes
Pages6
File Size0 KB
Price£40.00


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