# K960229: Resound Real Ear Loudness Mapping (Relm) System

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Mar 7, 1996 after 50 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
Longest line of descent: 1 generation back to K872242 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912669: Resound Portable Prescriptive Programming System, Resound Corp. (1991) Summary page 1.
- K872242: Type 6400 Real Ear Hearing Aid Analyzer, Frye Electronics, Inc. (1987) Summary page 1.
- K945750: Resound (R) Resource (TM), Resound Corp. (1995) Summary page 1.

## Indications for use
Similar to the Loudness Growth in Octave Bands (LGOB) Test provided with the ReSound® P3 System, this new hearing device fitting method is designed to measure loudness growth in hearing-impaired subjects in sound field, instead of with insert phones, in the unaided and aided conditions, through the use of subjective and objective measures, thus integrating both electroacoustic and psychoacoustic test capabilities.

Source page: https://510kreport.com/device/K960229
Methodology: https://510kreport.com/methodology