# K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: May 13, 1997 after 210 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 K944735 (1994). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944735: Bio-Logic Emav Emission Averaging Otoacoustic Test, Bio-Logic Systems Corp. (1994) Summary page 1.

## Most influential descendants
- K112247: A Baer with Abaer I/O Function (2012), 1 descendant of its own
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (2011), 1 descendant of its own
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own
- K121512: Scout Sport Otoacoustic Emissions Measurement System (2012), 0 descendants of its own

## Indications for use
The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (I/O) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing-impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing. DPOAE threshold is the lowest stimulus intensity level which produces a DPOAE response amplitude that is distinguishable from the level of system distortion and from the noise floor. DPOAE threshold is expressed in much of the published literature as the lowest intensity of the F2 stimulus that generates a clear DPOAE response. DPOAE threshold does not equate to and should not be confused with audiometric or auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures are limited to assessment of outer hair cell function in the cochlea only.

Source page: https://510kreport.com/device/K964132
Methodology: https://510kreport.com/methodology