# K110286: GN Otometrics Type 1053 Freefit

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: Apr 28, 2011 after 87 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: 3 generations back to K884046 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061104: Speechlink 100 Type 1053, Gn Otometrics A/S (2006) Summary page 1.

## Indications for use
Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing instrument settings. Note also that the Type 1053 FreeFit is designed for use in combination with NOAHLink -HIMSA's wireless hearing instrument programming device.

Source page: https://510kreport.com/device/K110286
Methodology: https://510kreport.com/methodology