Reporting by Heidi Godman
Photo by Bose Corp.
This may be the year that safe, inexpensive over-the-counter (OTC) hearing aids become available. In 2017, Congress passed a law directing the FDA to come up with a new category of hearing aids requiring special regulations and FDA approval. These hearing aids would be available from any seller, without doctor appointments or fittings, and sold at a fraction of the typical cost — about $600 per pair instead of the average $5,000 (which includes fittings and follow-up services).
Just one problem: the FDA missed the August 2020 deadline to come up with safety and labeling rules.
In October 2021, the FDA moved forward and issued proposed rules for the OTC category. Approval is expected....
Read the original article on Harvard Health Publishing here.
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