# K122028: Aurical Hit

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics
- Decided: Oct 23, 2012 after 105 days
- Product code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)
- Device class: 2
- Regulation: 21 CFR 874.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945199 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113831: Primus Hearing Instrument Test Unit, Auditdata A/S (2012) Summary page 2.

## Indications for use
The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

Source page: https://510kreport.com/device/K122028
Methodology: https://510kreport.com/methodology