# K071462: Unity 2 Hia & Probe ( for Use with Unity 2)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Hearing Instruments, Inc.
- Decided: Jun 5, 2007 after 11 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103298: Acam 5 Audiometer System (2011), 0 descendants of its own

## Indications for use
The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Unity 2 modules.

Source page: https://510kreport.com/device/K071462
Methodology: https://510kreport.com/methodology