# K103760: TITAN

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: May 5, 2011 after 133 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- 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 K060539 (2006). 2 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K060539: DPOAE20 , Eclipse, Interacoustics A/S, Assens (2006) Summary page 1.
- K082035: Maico MB 11 with Beraphone Probe, Maico Diagnostics (2009) Summary page 1.

## Most influential descendants
- K130795: TITAN (2013), 4 descendants of its own
- K171506: Easyscreen (2017), 1 descendant of its own
- K191372: Lyra (2019), 0 descendants of its own
- K173567: Sera (2018), 0 descendants of its own
- K172403: GSI Novus (2017), 0 descendants of its own

## Indications for use
The Titan with DPOAE44O is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE44O includes all ages. The Titan with ABRIS44O is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.The target population for Titan with ABRIS440 is newborns.

Source page: https://510kreport.com/device/K103760
Methodology: https://510kreport.com/methodology