Marcus Gould Hi Jakob

Under the medical device directive for CE Mark, hearing aids are class IIa, Rule 9 of Annex IX.

Marcus

Karen Boyd, ASQ CQA If the hearing aid is under US FDA jurisdiction, it could be either Class I or Class II. FDA classification depends upon the device technology, intended use, and any substantially equivalent devices.

Alvin Tai You should take a look at the FDA's guidance on Hearing Aids: http://www.fda.gov/RegulatoryInformation/Guidances/ucm373461.htm

Abdul Haleem Hearing aids belongs to class I

Jakob Nielsen Thank you for your answers everybody ! But can i read somewhere how much validation i have to perform for a medical device in either class 1-2 or class 3 ?

James (Jim) Dent, LSSBB, DTMx2 @Abdul - does that also apply to "surgically implanted hearing aids"? These would also be Class I?
I think the type of hearing aid will depend on the classification.

What type of hearing aid is Jakob asking about?

Jakob Nielsen Hi Jim, i am just asking about hearing aids in general... I can read in the link alvin give me that normal hearing aids are class 1 and surgically implanted hearing aids are class 2 if i understand correct....

Hi Jakob, indeed hearingaid are class 1.

Abdul Haleem Mr. Jim, you are right. Surgically fitted hearing aids has different category, its all depends case to case.

Abdul Haleem Mr. Jacob,
Surgically fitted hearing aids are in class II

Karen Boyd, ASQ CQA (Re: Alvin's comment - I inadvertently clicked on "Report spam" instead of following the FDA link he provided! My apologies to Alvin. Joe Hage, please take note. Thank you.)

I cleared the flag, Karen. Alvin, you're welcome here any time!

Karen Boyd, ASQ CQA Thanks Joe. Yes, of course Alvin. :)

Karen Boyd, ASQ CQA Back to the discussion, my earlier comment, pertaining to hearing aid device classification, was derived from following FDA's web-based Product Classification database (under Medical Devices, then Databases). I located the following product codes: ESD (Class 1), OSM (Class 2), NIX (Class 2), and LXB (Class 2). Perhaps one of these fits the device Jakob is inquiring about? Thanks.

Annamaria Heldne Nagy There are many helpful questionnaires that guide you through multiple questions. Let me see if I can find one.

Alvin Tai No problem! Thanks, Karen and Joe!

I am looking for information regarding the necessary, if any, registration for Packing Group 2 hazardous medical waste containers. I am importing containers from Europe to sale to distributors in the USA. Thank you

Whatever the class, you will need to consider the biocompatibility of the final device if it contacts the body. Let me know if you need any help with this aspect

Jakob Nielsen If its just in contact with the body like an normal hearing aid its class 1, but do you have to operate it into the body its class 2 and maybe some devices is class 3....
What about if you have an needle on the device you put into the body, is it then class 2 too ? does anyone have an example on a class 3 device ?

a catheter that enters the central circulation would be one.
A hip implant another.

Abdul Haleem Dear Jakob,
In that case needles are in class II a.
Simple example of class 3 is bulldog clamps.

Trent Pierce From my understanding of the FDA classifications regarding the patient specific surgically implanted hearing devices, those would actually be Class III, and tracked through the FDA.