- Published on 13 November 2019
US Food and Drug Administration regulations on over-the-counter (OTC) hearing aids were expected to be announced this November. Scratch that, if strong rumours of a delay in issuing these key rules until the first quarter of 2020 hold up.
Although the FDA itself has not yet announced a delay, reporters at The Hearing Review this week blogged a rumour from industry source analyst Niels Leth of Carnegie Research to the effect that the key Notice of Proposed Rulemaking (NPRM) document is stuck in administrative traffic on its way to the Office of Information and Regulatory Affairs (OIRA). The paperwork journey habitually takes from four to eight weeks, meaning a possible January or February release, still way ahead of the FDA's August 18, 2020 deadline.
All players in the US hearing industry have been eagerly awaiting news this November of what FDA requirements for over-the-counter sales will amount to. The OTC Hearing Aid Act of 2017 was passed by Congress and signed by President Donald Trump on August 18, 2017, leaving the FDA with the obligation of creating and regulating within three years a category of OTC hearing aids for adults with “perceived” mild-to-moderate hearing loss and of ensuring the devices meet the same high standards for safety, consumer labelling, and manufacturing protection in line with all other medical devices.
When the regulations do arrive, their content will stir up heated debate at the very least. This year, the Hearing Industries Association (HIA) sent a letter to the FDA arguing that the standards applied in testing for US authorisation for self-fitting hearing aids might "jeopardise the hearing health of consumers".
Source: The Hearing Review