# K061104: Speechlink 100 Type 1053

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: May 3, 2006 after 13 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 K884046 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012306: Audioscan Verifit, Model VF-1, Etymonic Design, Inc. (2001)
- K033645: Otoflex 100 Tye 1012, Gn Otometrics A/S (2004) Summary page 1.

## Most influential descendants
- K110286: GN Otometrics Type 1053 Freefit (2011), 0 descendants of its own

## Indications for use
The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

Source page: https://510kreport.com/device/K061104
Methodology: https://510kreport.com/methodology