# K183201: Hearing Healthcare Pro

- Pathway: 510(k) (Traditional)
- Applicant: Db Diagnostic Systems, Inc.
- Decided: Mar 6, 2019 after 107 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K902540 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171038: Hearing Healthcare Pro, Db Diagnostic Systems, Inc. (2017) Summary page 4.

## Indications for use
The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a “normal” or “abnormal” determination. If the decision is “abnormal”, the software can make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and may be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.

Source page: https://510kreport.com/device/K183201
Methodology: https://510kreport.com/methodology