But Wait…There’s More! Part 2 – Labeling

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.   This is the second of three posts that summarizes the Hearing Industries Association’s (HIA) recommendations to the Food and Drug Administration’s (FDA) Office of Device Evaluation, the office primarily responsible for promulgating the OTC hearing aid rules following the passage and signing of…

Read More

On-Site Reporting from NAS Public Meeting Last Week

by Barbara Weinstein Downstream Consequences of Aging is a bi-monthly series written by guest columnist Barbara Weinstein, PhD.  Today’s post gives readers a sense of the simultaneous breathless drama and grinding diligence experienced by all participating stakeholders at last week’s pivotal NAS meeting.   The Plenary: Sounds of Silence   At the Dec. 7, 2016 Dissemination…

Read More

With a Tale, Forsooth, Northey Cameth Unto Us

The Tom Northey series concludes today, wrapping up his 2000 treatise forecasting the future of our profession.1 He foresaw systematic changes headed straight at us and anticipated questions and issues that would rain down upon us.   Northey predicted a world of Audiology survivors and losers,  advised Audiologists to look beyond hearing aids for survival strategies, and gave Audiologists common-sense recommendations which we…

Read More

Regulation of Hearing Aids in the US, Part 5

The FDA Regulation: 1977 Final Rule By 1977, the momentum driving hearing aids into the medical device arena was unstoppable. On Feb. 15, 1977, the FDA published its Final Rule, which made hearing aids restricted devices, promulgated regulations governing professional and patient labeling, and set forth conditions for the sale of hearing aids.1 The detail…

Read More