Standards Spotlight

Standards Support These Invaluable Assistive Devices

Consumers can now purchase hearing aids over the counter in the U.S., as a 2017 federal law takes effect. Over-the-counter (OTC) hearing aids, available at big box stores, drug stores, and other retailers, will cost significantly less than prescription aids—many will be priced at hundreds of dollars, versus the thousands of dollars needed for prescription hearing aids. This will have a profound impact on millions of Americans with mild to moderate hearing loss who previously could not afford assistive devices.

Prescription hearing aids partner patients with audiologists who provide hearing evaluations, fittings, and fine-tuning of the devices. The OTC hearing aids will be set up by consumers themselves, with the assistance of apps and customer service, but will use some of the same technologies found in their pricier counterparts. Much of this technology, as well as the fitting and use of hearing aids, is guided by standards that support their safe use and effectiveness.

The Acoustical Society of America (ASA) is a member and accredited standards developer of the American National Standards Institute (ANSI) that has developed many standards and guidelines for hearing aids. They include:

• ANSI ASA S3.22, Specification of Hearing Aid Characteristics, an American National Standard (ANS) that describes hearing aid measurements that are particularly suitable for specification and tolerance purposes
• ANSI/ASA S3.46, Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids, an ANS that guides the measurement of the acoustic output and acoustic gain of hearing aids, coupled to human ears, in a variety of acoustic environments and for the measurement of certain acoustic properties of the ear related to the application of hearing aids
• ANSI/ASA S3.35, Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions, describes techniques used to measure hearing aids under simulated conditions of real ear use

International standards guide hearing aid development and use as well. ISO 21388, Acoustics – Hearing Aid Fitting Management, applies to hearing aid fitting management services offered by hearing aid professionals. It was developed by the International Organization for Standardization (ISO) Technical Committee (TC) 43, Acoustics. ASA is the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to this TC.

Electrotechnical standards support the safe use of hearing aids. IEC 60601-2-66, Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems, is an international standard developed by the International Electrotechnical Commission (IEC) TC 29, Electroacoustics. ASA is the USNC-accredited TAG administrator to this TC as well.

Some people with severe hearing impairments choose to undergo cochlear implant surgery, a procedure where a small electronic neuroprosthesis is implanted to stimulate the cochlear nerve and mimic natural hearing. Standards guide these devices, too. ANSI/AAMI CI86, Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting, is an ANS developed by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and standards developer.

Learn more about OTC hearing aids, including where to purchase them and what types are available: You can now buy lower-cost hearing aids over the counter. Here’s how.