# K971399: Auris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris Coe, Auris Cic

- Pathway: 510(k) (Traditional)
- Applicant: General Hearing Instruments, Inc.
- Decided: Jun 13, 1997 after 59 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
Mild to severe conductive, mixed or sensoryneural hearing loss Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern. Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired. Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM. Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.

Source page: https://510kreport.com/device/K971399
Methodology: https://510kreport.com/methodology