# K923784: Starkey SM Series Bte Hearing Aids

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Aug 26, 1992 after 29 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K953872: Second Ear Bone Conduction Hearing Aid (1996), 3 descendants of its own
- K050653: Transear Bone Conduction Hearing Aid (2005), 2 descendants of its own
- K100649: Soundbite Hearing System by Sonitus (2011), 1 descendant of its own
- K110831: Soundbite Hearing System by Sonitus Medical (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K923784
Methodology: https://510kreport.com/methodology