OTC Ready™ technologies, the ideal platform for rapid market entry
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press@jacoti.comby Jacoti Staff
The ideal platform for rapid market entry
The Food and Drug Administration (FDA) is developing proposed regulations for over-the-counter (OTC) hearing aid devices. According to the FDA Reauthorization Act of 2017, these devices will be available to the consumer through retail outlets and without having to engage an audiologist, either for a pre-purchase hearing evaluation or for the selection, fitting or verification of performance of the device.
In August 2017, Congress passed into law the OTC Hearing Aid Act of 2017.
The OTC law passed by Congress (S934: FDA Reauthorization Act of 2017) defines an OTC device as one that:
(A)Jacoti sound personalisation is designed following audiological standards
uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);
(B)Know more about Jacoti’s focus on mild to moderate hearing losses
is intended to be used by adults over the age of 18 to compensate for perceived mild to moderate hearing impairment;
(C)Jacoti solutions have been always designed putting the user in control of their devices
through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customise it to the user’s hearing needs;
(D)Jacoti Inside Qualcomm 51XX series
may–
(i) use wireless technology; or
(ii) include tests for self-assessment of hearing loss;
(E)To be connected with a hearing expert through Jacoti earCloud® is optional after the device purchase
and is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.
Jacoti already complies with the necessary medical regulations
Jacoti is certified to the requirements of EN ISO 13485:2016 and Annex II (excluding section 4) of the EU Medical Device Directive and is also registered as Medical Device Manufacturer at the USA Food and Drug Administration.
Jacoti ListenApp is a Class I FDA Registered Medical Device, classified under product code ESD, and Jacoti Hearing Center is a Class II FDA listed Medical Device, classified under product code EWO.
As Medical Devices, they are designed, developed and manufactured in accordance with a quality system compliant with 21 CFR Part 820 (United States quality requirements).
Jacoti regulatoryConsensus paper from hearing care associations (2018)