# K070118: Otogram, CA3350

- Pathway: 510(k) (Traditional)
- Applicant: Tympany, Inc.
- Decided: Mar 7, 2007 after 54 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
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. The FDA summary names its predicate without a number.
- (no number) Tympany Otogram combination device: named in the summary without a submission number

## Indications for use
The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer) The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders. The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following: 1) Pure tone air and bone conduction audiometry with automated masking 2) Speech recognition threshold with automated masking 3) Speech discrimination with automated masking 4) Tympanometry 5) Acoustic reflex threshold, both ipsilateral and contralateral 6) Distortion product otoacoustic emissions 7) Pure tone Stenger 8) Patient survey

Source page: https://510kreport.com/device/K070118
Methodology: https://510kreport.com/methodology