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Hi,
I work for a hearing aid manufacturer and recently, FDA released a new rule on OTC hearing aids found in this link:
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
| Federal Register |
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| Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids |
| The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable... |
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I have a question specific to labelling requirements: FDA has issued a new regulation that requires Hearing Aid manufactures to add 3 specific warnings and some additional information to the outer packaging. It applies to all devices launched in US after October 17, 2022 as well as all hearing instruments already on the market from April 14, 2023.
Since this is required for the next 2 weeks, are we able to use an extra label additional to our existing regulatory label in our outer packaging so that we don't have to update all our existing labels for now?
Please let me know if anyone can help.
Thank you!