# K043219: Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics AS
- Decided: Feb 4, 2005 after 74 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K141524: Neuro-Audio (2015), 0 descendants of its own

## Indications for use
The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss. The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers

Source page: https://510kreport.com/device/K043219
Methodology: https://510kreport.com/methodology