# K974219: Faceplate Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Finetone Hearing Instruments
- Decided: Feb 20, 1998 after 102 days
- Product code: LRB (Face Plate Hearing Aid)
- 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 M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-KAMP detects and amplifies quiet sounds. In foud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls. 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/K974219
Methodology: https://510kreport.com/methodology