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Description of ASTM-F2504 2005ASTM F2504 - 05Standard Practice for Describing System Output of Implantable Middle Ear Hearing DevicesActive Standard ASTM F2504 | Developed by Subcommittee: F04.37 Book of Standards Volume: 13.02 ASTM F2504Significance and Use IMEHDs are alternatives to air conduction hearing aids. They are similar to air conduction hearing aids in that they process incoming sound by applying frequency shaping and compression to create an analog, vibratory audio frequency output. IMEHDs differ from hearing aids in that they do not create an airborne acoustical output signal with an electroacoustical output transducer in the external ear canal, but rather a mechanical stimulation that results in the vibration of the cochlear fluid. Therefore, the IMEHD output signal is not readily accessible after implantation in the way hearing aid output is accessible with real-ear probe microphone measurements. Different devices will use different methods of coupling to the ossicular chain or cochlea. This makes it difficult to design a uniform model of the middle ear in the way the 2-cm 3 coupler is used as a model of the external ear canal with conventional hearing aids. This practice provides uniformity of data collection practices, thus allowing IMEHD in vitro performances to be evaluated and readily compared. Once clinical data are available, the performance specifications can be augmented with corresponding transfer functions or results from measurements in patients. The temporal bone is a well-accepted model that relates closely to the biomechanics of the living middle ear, which is readily relatable to hearing level. Laser Doppler vibrometry provides accurate velocity measurements in the ranges required for human hearing. 1. 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. 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.
ANSI Standards ANSI3.22 Specification of Hearing Aid CharacteristicsKeywords 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; ICS Code ICS Number Code 11.180.15 (Aids for deaf and hearing impaired people) DOI: 10.1520/F2504-05 ASTM International is a member of CrossRef. ASTM F2504The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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