ANSI - American National Standards Institute
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Voluntary Standards Cover the Spectrum: from Hearing Assistance Devices to Implantable Glaucoma Devices


07/27/2015

In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI) publishes snapshots of the diverse standards initiatives undertaken in the global and national standards arena, many of which are performed by ANSI members and ANSI-accredited standards developers. Two of the latest selections follow:

Hearing Assistance Devices

According to the National Information Center on Deafness and Other Communication Disorders (NIDCD), approximately 20% of adults in the United States report some degree of hearing loss, and as we age that number increases dramatically. Assisted listening devices help people with hearing, voice, speech, and language disorders communicate more meaningfully and participate more fully in their daily lives. A new American National Standard (ANS) from the Acoustical Society of America (ASA) was recently released to specify performance requirements to ensure that assisted listening devices are safe and effective.

ANSI/ASA S3.47-2014, Specification of Performance Measurement of Hearing Assistance Devices/Systems, defines various types of hearing assistance devices/systems (HADS) and describes procedures for measuring their performance characteristics. For the purpose of providing consistent product descriptions and maintaining consistent expectations for product performance for each model, this standard provides guidelines for the description of the physical characteristics of HADS; guidelines for the description of the transmission methods used in HADS; and procedures for measuring electroacoustic characteristics accurately and consistently.

ASA, an ANSI accredited standards developer and organizational member, is dedicated to increasing and diffusing the knowledge of acoustics and its practical applications, as well as fostering studies of noise, its measurement, its effects, and ways of reducing noise to improve the human environment. ASA serves acoustics professionals throughout the U.S. and abroad in a variety of fields related to sound including physics, engineering, robotics, oceanography, architecture, music, noise control, and many others.

Implantable Glaucoma Devices

The World Health Organization estimates that there are 70 million cases of glaucoma worldwide, and asserts it is the second leading cause of blindness. Glaucoma is a group of eye disorders that result in optic nerve damage, often associated with increased fluid pressure in the eye. It can develop slowly over time, referred to as open-angle glaucoma, or it can appear suddenly causing a medical emergency, referred to closed-angle glaucoma. And once lost, vision cannot normally be recovered, so current treatments are aimed at preventing further vision loss.

To facilitate glaucoma treatment, the Vision Council, an ANSI accredited standards developer and organizational member, recently published ANSI Z80.27-2014, Ophthalmics - Implantable Glaucoma Devices. This new ANS applies to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms. ANSI Z80.27-2014 describes the physical, mechanical, and biocompatibility properties, as well as the elements of clinical protocols that may be useful in assessing the clinical performance of these implantable glaucoma devices.

Dedicated to enhancing life through better vision, the Vision Council represents the manufacturers and suppliers of the optical industry through advocacy and the promotion of quality vision care products and services in the global community. This non-profit, membership organization offers research and training to the industry, and serves as a liaison with consumers, providing education about the importance of vision care and the options in vision care products.

 Homeland Defense and Security Standardization Collaborative