# K970828: Uhs Micronet Programmable Hearing Aids Models 901,902,903,906,909/Programmer

- Pathway: 510(k) (Traditional)
- Applicant: United Hearing Systems, Inc.
- Decided: May 28, 1997 after 83 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
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies): Severity: Slight, Mild, Moderate Configuration: High Frequency, Gradually Sloping, Reverse Slope, Flat Other: Low tolerance to loudness

Source page: https://510kreport.com/device/K970828
Methodology: https://510kreport.com/methodology