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Homepage>ASTM Standards>ASTM F2504-05R14 - Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
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Released: 2014-04-07

ASTM F2504-05R14

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

CURRENCY
64.2 USD
Language:English
Released:2014-04-07
Pages:6
Standards number:ASTM F2504-05R14
Standard number:F2504-05R14
Released:01.03.2014
Status:Active
Pages:6
Section:13.02
Keywords: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
DESCRIPTION

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.