# K060885: Model MI 44 Tympanometer

- Pathway: 510(k) (Traditional)
- Applicant: Maico-Diagnostics
- Decided: Jun 5, 2006 after 66 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081841: Amplivox Otowave 102 Hand Held Portable Tympanometer (2008), 1 descendant of its own
- K150163: Otowave 202 Portable Tympanometer (2015), 0 descendants of its own

## Indications for use
The Maico Diagnostics model MI 44 Tympanometer is intended for use by trained operators in hospitals, ENT clinics and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. This is accomplished by measuring the acoustic impedance of the ear canal under various conditions.

Source page: https://510kreport.com/device/K060885
Methodology: https://510kreport.com/methodology