# K012306: Audioscan Verifit, Model VF-1

- Pathway: 510(k) (Traditional)
- Applicant: Etymonic Design, Inc.
- Decided: Sep 21, 2001 after 60 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: 1 generation back to K884046 (1989). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884046: Audioscan (TM) Real Ear Measurement System RM500, Etymonic Design, Inc. (1989) Summary page 2.

## Most influential descendants
- K061104: Speechlink 100 Type 1053 (2006), 1 descendant of its own
- K110286: GN Otometrics Type 1053 Freefit (2011), 0 descendants of its own

## Indications for use
The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber of a hearing aid when worn by a patient.

Source page: https://510kreport.com/device/K012306
Methodology: https://510kreport.com/methodology