# K980377: Fonix FP35 Hearing Aid Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Frye Electronics, Inc.
- Decided: Mar 18, 1998 after 44 days
- Product code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)
- Device class: 2
- Regulation: 21 CFR 874.3310
- 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 device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic perfoFmance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient’s ear in a test to determine his psychoacoustic comfort levels.

Source page: https://510kreport.com/device/K980377
Methodology: https://510kreport.com/methodology