Are Hearing Aids classified as Class I or Class II under EU?

[Karichan]

Hello

May I ask that the Hearing Aids should be classified as Class I or Class II under EU?

Thank you

 

[Gert Sorensen]

Class IIa, short term invasive.

 

[Guillaume Prom]

I'm OK for class IIa, but I think that it's rule #9: active device that administer energy (where sound = energy).

 

[c.mitch]

Hi guillaume,
Yes. Class IIa according to rule #9. I saw another manufacturer having its products in this class in EU.

 

[dgrainger]

FYI - MEDDEV 2. 4/1 Rev. 9 P39 lists Hearing aids as class IIa.

ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm