# K983832: Interacoustics Model MT 10, Handheld Impedance Audiometer

- Pathway: 510(k) (Traditional)
- Applicant: Idem (Int'L Dist. of Electronics For Medicine)
- Decided: Jan 25, 1999 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Grason Stadler GSI-37 Auto Tymp: named in the summary without a submission number

## Indications for use
The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.

Source page: https://510kreport.com/device/K983832
Methodology: https://510kreport.com/methodology