# K151025: iHearTest

- Pathway: 510(k) (Traditional)
- Applicant: Ihear Medical, Inc.
- Decided: Dec 29, 2015 after 257 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 K850123 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982878: Earscan 3, Micro Audiometrics Corp. (1998) Summary page 4.
- K021867: Insound XT Series Hearing Aid, Insound Medical, Inc. (2002) Summary page 4.
- (no number) Maico MA1 Handheld Audiometer: named in the summary without a submission number

## Indications for use
The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.

Source page: https://510kreport.com/device/K151025
Methodology: https://510kreport.com/methodology