# K971845: Heartland Technologies, Ite, Itc, Cic

- Pathway: 510(k) (Traditional)
- Applicant: Sound Hearing Instruments, Inc.
- Decided: Aug 15, 1997 after 88 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- 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 no predicate by number.

## Indications for use
General Indications: Severity: Slight, Mild, Moderate, Severe Configuration: High Frequency, Gradually Sloping, Reverse Slope, Flat Other: Low tolerance to loudness

Source page: https://510kreport.com/device/K971845
Methodology: https://510kreport.com/methodology