# K970340: Air Conduction Assistive Listening Device.Personal Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Bellab
- Decided: Mar 26, 1997 after 56 days
- Product code: LZI (Device, Assistive Listening)
- Device class: 2
- Regulation: 21 CFR 874.3320
- 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 indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies): Mild; Moderate; Gradually Sloping.

Source page: https://510kreport.com/device/K970340
Methodology: https://510kreport.com/methodology