# K971032: Danavox Models 163/162 Bte

- Pathway: 510(k) (Traditional)
- Applicant: Gn Danavox, Inc.
- Decided: Jun 17, 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
Longest line of descent: 1 generation back to K905692 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905692: 143 Series Bte, Gn Danavox, Inc. (1991) Summary page 1.

## 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).

Source page: https://510kreport.com/device/K971032
Methodology: https://510kreport.com/methodology