# K981327: Interacoustics Model AD226 Diagnostic Audiometer

- Pathway: 510(k) (Traditional)
- Applicant: Idem (Int'L Dist. of Electronics For Medicine)
- Decided: May 11, 1998 after 28 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.
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) Beltone Model 110 Audiometer: named in the summary without a submission number

## Indications for use
The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Source page: https://510kreport.com/device/K981327
Methodology: https://510kreport.com/methodology