# K110973: IE-Zen (in Clear Series Hearing Aid)

- Pathway: 510(k) (Special)
- Applicant: Widex USA
- Decided: May 5, 2011 after 29 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974501 (1998). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080955: Zen Program (Mind 440 Hearing Aid), Widex Hearing Aid Co., Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K101699: WidexLink in CLEAR440. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own
- K133308: Tinnitus Soundsupport (2014), 2 descendants of its own
- K151719: REVE134 (2015), 1 descendant of its own
- K221168: Tinnitogram Signal Generator (2023), 0 descendants of its own

## Indications for use
The IE-Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

Source page: https://510kreport.com/device/K110973
Methodology: https://510kreport.com/methodology