# K942749: HI-Pro/Noah Universal Hearing Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Madsen Electronics (Canada), Ltd.
- Decided: Jul 18, 1994 after 38 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090720: Cochlear Baha BP100 (2009), 33 descendants of its own
- K132278: Cochlear Baha  4 Sound Processor (2013), 11 descendants of its own
- K103594: Ponto Pro Power (2011), 11 descendants of its own
- K142907: Baha 5 Sound Processor (2015), 10 descendants of its own
- K132775: Ponto Plus and Ponto Plus Power (2013), 10 descendants of its own

Source page: https://510kreport.com/device/K942749
Methodology: https://510kreport.com/methodology