# K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Aug 9, 1994 after 174 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K963838: Starkey TM Air Conduction Tinnitus Masker (1996), 7 descendants of its own
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker (1996), 6 descendants of its own
- K982451: Ttcghi-T and TTCTN3-T-T (1999), 2 descendants of its own
- K021202: Ultraquiet (2002), 1 descendant of its own
- K013253: Hisonic-TRD Tinnitus Relief Device (2002), 1 descendant of its own

Source page: https://510kreport.com/device/K940667
Methodology: https://510kreport.com/methodology