# K162210: touchTymp

- Pathway: 510(k) (Special)
- Applicant: Maico Diagnostics GmbH
- Decided: Nov 16, 2016 after 103 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- 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 K905704 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905704: MA630 Imped Screener/MA640 Imped/Audiomet Screener, Maico Hearing Instruments, Inc. (1991) Summary page 4.

## Indications for use
The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflex audiometry.

Source page: https://510kreport.com/device/K162210
Methodology: https://510kreport.com/methodology