# K984547: Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Mar 19, 1999 after 87 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- 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 K912669 (1991). 1 ancestor in all.
34 later devices descend from it; 1 cites it directly.
0 of 36 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 2.

## Most influential descendants
- K090720: Cochlear Baha BP100 (2009), 33 descendants of its own
- K132278: Cochlear Baha  4 Sound Processor (2013), 11 descendants of its own
- K103594: Ponto Pro Power (2011), 11 descendants of its own
- K142907: Baha 5 Sound Processor (2015), 10 descendants of its own
- K132775: Ponto Plus and Ponto Plus Power (2013), 10 descendants of its own

## Indications for use
The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource 11 fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals. The purpose of the ReSound LGOB test is to evaluate a patient’s suprathreshold hearing at specific frequencies. This is the range of hearing above a person’s threshold level but below their uncomfortable loudness level. The results of this test are used by the ReSource software to calculate hearing instrument fittings that are better tailored to the patient’s residual dynamic range of hearing. The LGOB test procedure requires the patient to evaluate narrow bands of noise signals generated directly the Digital-to-Analog converter within the hearing device. The patient indicates if the noise signal is Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible by entering their response with the hand held Personal Selector, which is the identical recording device used with the original P? system from ReSound. The new LGOB application uses the patient’s own digital hearing device or a stock “Digital Master” device to produce the sound stimulus directly from the Digital to Analog converter (DAC) within the hearing aid’s Digital Signal Processor. No insert earphones are required. Either BTE or Custom In-The-Ear devices can be used to perform the LGOB loudness scaling measurements. The test protocol is initiated and controlled by connecting a Digital hearing device to a personal computer and using proprietary fitting software (ReSource II). When the fitting computer is disconnected, the hearing instrument functions normally. Results from the test are used to provide fitting recommendations and initial device amplification parameter settings for the Digital 5000 and other programmable ReSound hearing devices.

Source page: https://510kreport.com/device/K984547
Methodology: https://510kreport.com/methodology