ASTM-F2504 2022

$34.13

F2504-05(2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Published By	Publication Date	Number of Pages
ASTM	2022

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Categories: 11.180.15 - Aids for deaf and hearing impaired people, ASTM

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Description

ASTM F2504-05-Reapproved2022

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

ASTM F2504

Scope

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

electromechanical hearing; hearing implant; IHD; IMEHD; implantable hearing aid; implantable middle ear hearing device; laser interferometry; middle ear; middle ear implant; system output; system performance; temporal bone; transfer function; vibrational transducer; vibratory implant;

ICS Code

ICS Number Code 11.180.15 (Aids for deaf and hearing impaired people)

DOI: 10.1520/F2504-05R22

Additional information

Standard Title	F2504-05(2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
Published Code	ASTM
Publication Date	2022
ICS Codes	11.180.15 - Aids for deaf and hearing impaired people