# K171506: Easyscreen

- Pathway: 510(k) (Traditional)
- Applicant: Maico Diagnostics GmbH
- Decided: Aug 29, 2017 after 98 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- 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 K060539 (2006). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103760: TITAN, Interacoustics A/S (2011) Summary page 4.
- K130795: TITAN, Interacoustics A/S (2013) Summary page 4.

## Most influential descendants
- K173567: Sera (2018), 0 descendants of its own

## Indications for use
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages. The device ABR module 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 the ABR module is newborns and infants up to 6 months of age. The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.

Source page: https://510kreport.com/device/K171506
Methodology: https://510kreport.com/methodology