# K984518: Sonic Innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell

- Pathway: 510(k) (Traditional)
- Applicant: Sonic Innovations, Inc.
- Decided: Mar 12, 1999 after 81 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: 2 generations back to K850123 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964603: Articular Hearing Aids, Decibel Instruments, Inc. (1996) Summary page 1.
- K915794: AD-Hear, Hearing Components, Inc. (1992) Summary page 1.
- (no number) SONIC innovations® CIC DSP hearing aid: named in the summary without a submission number

## Indications for use
The indication for use of the air conduction hearing aid 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): Mild, Moderate.

Source page: https://510kreport.com/device/K984518
Methodology: https://510kreport.com/methodology