# K113831: Primus Hearing Instrument Test Unit

- Pathway: 510(k) (Traditional)
- Applicant: Auditdata A/S
- Decided: Apr 19, 2012 after 114 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
Longest line of descent: 1 generation back to K945199 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945199: RH2000 Real Ear Measurement System, Madsen Electronics, Inc. (1995) Summary page 2.

## Most influential descendants
- K122028: Aurical Hit (2012), 0 descendants of its own

## Indications for use
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician. Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing. The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings. The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved. The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician. Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing. The Primus Fitting Unit is intended for hearing test. The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments. The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments. Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers. The Primus Fitting Unit is indicated for use with both pediatric and adult age groups. The Primus Fitting Unit is not indicated as a sole means of diagnostics.

Source page: https://510kreport.com/device/K113831
Methodology: https://510kreport.com/methodology