# K974069: Opus 2 - Canal Series (Itc)

- Pathway: 510(k) (Traditional)
- Applicant: Bernafon-Maico, Inc.
- Decided: Dec 15, 1997 after 48 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: Mild, Moderate, Severe Configuration: Gradually Sloping, Flat Other: Low Tolerance To Loudness

Source page: https://510kreport.com/device/K974069
Methodology: https://510kreport.com/methodology